Deliverable)1.2) Requirements)specification)and)pilot ... · EHR4CR!!...

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Electronic*Health*Records*for*Clinical*Research*

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Deliverable)1.2)Requirements)specification)and)pilot)evaluation)criteria)

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Version!1.1!

24th!October!2014!

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!!Project!acronym:!EHR4CR!Project!full!title:!Electronic!Health!Records!for!Clinical!Research!Grant!agreement!no.:!115189!Budget:!16!million!EURO!Start:!01.03.2011!K!End:!28.02.2015!Website:!www.ehr4cr.eu!

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The!EHR4CR!project!is!partially!funded!by!the!IMI!JU!programme!!

!Coordinator:

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EHR4CR!!

D1.2!Requirements!specification!and!pilot!evaluation!criteria! ! Page!2!

Document description

Deliverable no: 1.2!Deliverable title: Requirements!specification!and!pilot!evaluation!criteria!Description: Detailed!scenario!description!for!Patient!Identification!and!Recruitment!

Software!Requirements!Specification!for!Patient!Identification!and!Recruitment!Initial!evaluation!criteria!for!the!Protocol!Feasibility!Service!!

Status: Final, revised!Version: 1.1! Date:! 23rd!October!2014!Deadline: February!2013!Editors: Andreas!Schmidt,!Dipak!Kalra!

Type! Description! Communication!Vehicle!Report! xx! xx!

xx! xx! xx!

xx! xx! xx!

Outputs:*

Other! xx! xx!

Document history Date Revision Author(s) Changes 28/2/2013 0.1 Dipak Kalra Integrating initial contributions

from Richard and Töresin, plus short Executive Summary

4/4/2013 0.3 Dipak Kalra Integrating evaluation criteria summary from Nadir

26/4/2013 1.0 Dipak Kalra Addition of an updated Annex on evaluation criteria

24/10/2014 1.1 Dipak Kalra Expanded executive summary to relate the content to the Description of Work, page separators between the annexes

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Table)of)Contents)!

1! Executive!Summary .......................................................................................................................... 4!

1.1! Relationship!to!the!Description!of!Work ................................................................................... 4!

2! Scenarios!and!requirements!for!Patient!Identification!and!Recruitment ........................................ 5!

2.1! Introduction............................................................................................................................... 5!

2.2! Objectives .................................................................................................................................. 5!

2.3! Problems!being!addressed ........................................................................................................ 5!

2.4! Approach!and!activities!undertaken ......................................................................................... 6!

2.5! Results!and!outputs................................................................................................................... 6!

2.6! Relationship!to!the!rest!of!the!project ...................................................................................... 6!

2.7! Next!steps.................................................................................................................................. 7!

3! Pilot!evaluation!criteria .................................................................................................................... 8!

4! List!of!annexes.................................................................................................................................. 9!

4.1! Annex!1!K!Scenarios!for!the!EHR4CR!Platform!and!Business!Model.......................................... 9!

4.2! Annex!2!K!Patient!Recruitment!Software!Requirements!Specification!v!1.0 ............................. 9!

4.3! Annex!3!K!Evaluation!of!the!EHR4CR!Pilots................................................................................ 9!

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EHR4CR!!


1 Executive Summary

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Work!Package!1!focuses!on!the!stakeholders!and!their!requirements!for!the!scenarios!being!

developed!in!project,!including!governance!and!evaluation!criteria.!!

This!deliverable!D1.2!reports!new!research!undertaken!within!work!package!1,!during!the!year!2!of!the!project.!This!work!defines!in!detail!the!scenario!of!Patient!Identification!and!Recruitment!to!clinical!trials,!and!the!corresponding!specification!of!requirements!for!the!EHR4CR!platform,!tools!

and!services!to!support!this!scenario!across!Europe.!!

The!methodology!adopted!mirrors!that!used!to!during!year!1!to!develop!the!scenario!and!requirements!for!Protocol!Feasibility,!reported!in!Deliverable!1.1.!!

The!evaluation!methodology!will!comprise!evaluation!criteria!common!to!all!scenario,!and!specific!criteria!targeted!at!demonstrating!the!value!of!present!scenario.!

Other!areas!of!work!reported!in!that!previous!deliverable!are!still!ongoing,!but!have!not!reached!the!

level!of!completions!that!warrants!reporting!on!them!here.!Their!progress!is,!however,!documented!within!the!project's!year!2!annual!report.!

As!last!time,!this!deliverable!primarily!comprises!the!actual!technical!documents!that!were!generated!and!used!within!the!project!during!this!year,!in!their!original!form.!Although!their!development!was!

led!from!WP1,!their!content!was!developed!with!input!from!the!other!work!package!groups,!who!have!also!signed!off!the!deliverables!are!as!ready!for!implementation.!

There!are!complementarities!between!this!deliverable!and!the!work!of!work!package!2,!for!example!in!relation!to!stakeholder!engagement,!and!this!deliverable!should!therefore!be!read!in!conjunction!

with!Deliverable!2.2.!

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1.1 Relationship to the Description of Work

In!the!original!DoW!a!waterfall!platform!development!methodology!was!foreseen.!In!practice,!the!

design!and!implementation!of!each!of!the!scenarios!has!been!progressed!as!independent!cycles:!this!has!been!helpful!in!enabling!the!project!to!experience!the!full!cycle!for!Protocol!Feasibility!and!using!

the!lessons!learned!for!the!second!scenario:!Patient!Identification!and!Recruitment.!As!a!consequence,!Work!package!1,!and!this!deliverable,!is!reporting!the!requirements!and!detailed!Software!Requirements!Specification!for!Scenario!2!(Section!2!of!this!report),!and!the!evaluation!

methodology!and!criteria!planned!for!the!Protocol!Feasibility!deployment!(Section!3!of!this!report).!!

Progress!has!been!made!in!other!tasks!within!Work!package!1,!such!as!on!stakeholder!engagement!and!information!governance,!which!will!be!reported!later!in!Deliverable!1.3.!

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2 Scenarios and requirements for Patient Identification and Recruitment

2.1 Introduction A! well! conducted! requirements! gathering! and! analysis! process! is! an! important! first! step! in! the!development! of! a! usable! and! efficient! application.! This! process! consolidates! all! needs,! constraints!and!requirements!in!a!structured!way!within!scenario!and!software!requirements!specification!(SRS)!

documents.!!

Four!clinical!research!scenarios!have!been!defined!within!the!scope!of!this!project!and!prioritized!by!the!Executive!Committee:!

1.! Clinical!protocol!feasibility!2.! Patient!identification!and!recruitment!

3.! Clinical!trial!execution!4.! Adverse!event!reporting!!

During!Year!2!we!have!completed!the!scenario!and!requirements!definition!for!Patient!Identification!and!Recruitment!and!this!forms!the!focus!of!Deliverable!1.2!

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2.2 Objectives • Define!operational!scenarios!for!the!domain!of!Patient!Identification!and!Recruitment!!• Define!system!(platform)!requirements!based!on!operational!scenarios,!stakeholder!inputs,!and!

inputs!from!staff!at!the!pilot!sites!!

• Develop!use!cases!and!workflows!to!elaborate!the!requirements!and!steer!the!development!of!tools!and!services!

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2.3 Problems being addressed Patient!recruitment!is!one!of!the!biggest!challenges!for!Pharma!because!as!many!as!50%!of!today’s!clinical!trials!fail!to!achieve!the!target!recruitment!rate.!Interventions!may!include:!

• extensions!to!recruitment!periods!that!impact!later!development!activities!• the!identification!of!additional!sites!to!cover!for!those!that!don’t!perform!as!expected!

• amendment!of!the!protocol’s!inclusion/exclusion!criteria!that!will!initiate!a!time!consuming!round!of!reKapprovals!and!system!updates!

• in!the!worst!case,!abandonment!of!the!trial!

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Studies!show!that!today’s!manual!process!for!identifying!patient!candidates!misses!27%!of!suitable!candidates!compared!with!electronic!searching.!In!addition,!other!treating!physicians!may!only!be!contacted!if!recruitment!rate!is!not!being!achieved!and!there!is!often!no!easy!mechanism!to!allow!

treating!physicians!to!proactively!refer!patients!as!candidates!for!a!clinical!trial.!

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2.4 Approach and activities undertaken The!requirements!engineering!process!adopted!within!EHR4CR!provides!a!methodology!for!the!

thorough!examination!of!the!envisaged!operational!environment!and!specification!of!application!functionalities!and!behaviours.!!!

The!following!activities!have!been!undertaken:!!

• Interviews!with!experts!from!pharma!and!academia!to!develop!a!comprehensive!understanding!of!the!current!process!for!patient!identification!and!recruitment,!user!issues!and!needs!

• Brainstorming!and!Requirements!Elicitation!Workshop!in!Düsseldorf!(23.04.2012K24.04.2012)!with!project!members!representing!user!groups!

• Compilation!of!Requirements!Scenarios!for!the!Patient!Identification!and!Recruitment!

domain!• Conceptual!modelling!of!the!patient!identification!and!recruitment!scenarios!(UML!use!case!

diagrams!and!descriptions)!

• Compilation!of!the!Software!Requirements!Specification!(SRS)!and!their!review!and!improvement!within!WP1!

• Requirements!validation!workshop!with!domain!experts!in!Paris!(09.10.2012!–!10.10.2012)!

• Stage!Gate!Process:!Requirements!Freeze!!

2.5 Results and outputs The!main!outputs!of!Tasks!1.2!and!1.3!comprise:!

1. Scenarios!for!the!EHR4CR!Platform!and!Business!Model!(Annex!1)!containing!relevant!domain!and!usage!scenario!descriptions.!

2. !Patient!Recruitment!Software!Requirements!Specification!v!1.0!(Annex!2)!containing!the!following!information:!

o Tools,!methods!and!approach!

o A!description!and!responsibilities!of!the!key!actors/roles!o Use!cases!that!specify!the!envisaged!interaction!of!actors!with!components!of!the!

envisaged!system!

o Functional!requirements!o NonKfunctional!requirements!(process!and!quality!factors)!o Data!Requirements!

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2.6 Relationship to the rest of the project The!requirements!scenarios!and!specifications!provide!input!for:!

• Technical!work!package!members,!who!will!translate!the!use!cases!and!requirements!into!a!

software!system.!!

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• Pilot!work!package!members,!who!will!use!the!SRS!for!the!use!and!evaluation!of!the!

developed!software.!!!

2.7 Next steps Planned!next!steps:!

• Improvement!of!the!requirements!engineering!process!and!requirements!specification!

document!• Requirements!engineering!for!third!scenario!(clinical!trial!execution)!

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3 Pilot evaluation criteria

Criteria!for!evaluating!the!pilots!are!now!being!developed.!

Two!major!components!are!in!the!scope.!!

• The!criteria!and!test!procedures!required!to!validate!that!the!system!works!as!it!is!intended!

to!work.!This!is!required!for!system!validation!against!the!requirements.!• The!criteria!and!test!procedures!required!to!demonstrate!that!the!value!propositions!are!

met.!This!requires!to!define!the!baseline!measurement!and!what!data!needs!to!be!generated!

for!comparative!analysis!and!value!demonstration.!

A!common!pilot!evaluation!methodology!and!framework!is!being!developed!as!part!of!Task!1.5.!!

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A!set!of!success!criteria!are!being!developed!to!support!both!a!quantitative!and!qualitative!evaluation.!

The!success!criteria!may!differ!depending!upon!the!targeted!audience,!as!the!perspectives!of!what!is!important!varies!amongst!the!different!stakeholders!(EFPIA!members,!Data!Providers,!Service!

Providers).!

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Some!of!the!items!developed!to!date!have!already!been!investigated!by!WP1,!WP4,!WP7!during!year!1,!and!need!not!be!repeated.!They!are!accessible!in!the!document!entitled!“Evaluation!of!the!EHR4CR!Pilots”,!included!in!Annex!3!

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At!first!the!list!of!key!success!criteria,!will!be!developed!derived!from!the!requirements!and!the!

specifications!–!asking!the!question:!what!needs!to!be!demonstrated!to!show!evidence!of!a!success.!

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The!list!will!be!circulated!for!input!and!enrichments.!A!consolidation!will!then!be!required!to!summarize!the!criteria!that!are!more!closely!reflecting!on!expected!tangible!value!to!be!

demonstrated.!

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The!current!list!of!criteria!and!the!test!procedures!are!provided!in!Annex!3!(in!development).!

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4 List of annexes

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4.1 Annex 1 - Scenarios for the EHR4CR Platform and Business Model

28!pages!

4.2 Annex 2 - Patient Recruitment Software Requirements Specification v 1.0

58!pages!

4.3 Annex 3 - Evaluation of the EHR4CR Pilots

1!page!

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Annex 1 - Scenarios for the EHR4CR Platform and Business Model

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!DOMAIN'AND'USAGE'SCENARIOS'FOR'THE'

EHR4CR'PLATFORM'AND'BUSINESS'MODEL''

!Author:( Richard!Perkins!/!Alan!Yeomans!

Version:( 2.5!

Date:! 17!January!2013

1.2 Scenarios for the EHR4CR Platform and Business Model January 2013

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2! Introduction++ Project(Confidential(!

Document Description Document Id N/A! Status Internal+Release+Candidate+

Document Type PROJECT!DELIVERABLE!! Security PROJECT!CONFIDENTIAL!Title Domain!And!Usage!Scenarios!For!The!EHR4CR!Platform!And!Business!Model!

Subject EHR4CR!Scenarios!

Document History Date Revision Author Changes

20!June!2011! 1.0! R.Perkins!/!A!Yeomans! Template!and!Initial!draft!

19!July!2011! 1.1! Alan!Yeomans! Separate!document!created!for!Protocol!Feasibility!and!Patient!Identification!and!Recruitment!Scenarios!Updated!with!comments!from!second!workshop!(Leverkusen)!User!storyboard!added!as!appendix!for!later!incorporation!into!domain!scenario!content!

20!July!2011! 1.2! R.Perkins!/!A!Yeomans! Release!of!Protocol!Feasibility!Scenario!for!consultation!with!internal!stakeholders!

28!August!2011! 1.3! R.Perkins!/!A!Yeomans! Updated!release!of!Protocol!Feasibility!Scenario!for!consultation!with!internal!stakeholders!for!WPG2!workshop!2!September!

27!September!2011! 1.4! Alan!Yeomans! Updated!Protocol!Feasibility!Scenario!with!review!comments!from!Jos!Devlies,!Johan!Pröve,!Martin!Dugas,!Sarah!Thew!and!Töresin!Karakoyun.!

2!April!2012! 2.1! R.Perkins!/!A!Yeomans! Release!of!Patient!Identification!and!Recruitment!scenario!for!review!by!workshop!participants!16`17!April!2012!Dusseldorf!

May!2012! 2.2! R.Perkins!/!A!Yeomans! Updated!Patient!Identification!and!Recruitment!scenario!post!workshop!for!!User!Requirements!development!

20!December!2012! 2.3! R.Perkins!/!A!Yeomans! Integrated!release!to!reflect!User!Requirements!post!Stage!Gate!5!November!2012!for!review!by!Dusseldorf!workshop!participants!

16!January!2013! 2.4! R.Perkins!/!A!Yeomans! Updated!integrated!release!with!review!comments!from!internal!review.!Internal!Release!Candidate!

17!January!2013! 2.5! R.Perkins!/!A!Yeomans! Removal!incorrect!information!flow!analysis!subsection!in!4.3!!


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Contents'1! Introduction ........................................................................................................................................................ 5!

1.1! How!to!Read!This!Document....................................................................................................................... 6!

2! Domain!Scenario:!General................................................................................................................................... 7!

2.1! Problem!Statement ..................................................................................................................................... 7!

2.2! Domain!Scenario!Overview ......................................................................................................................... 7!

2.3! Domain!Scenario!Details ............................................................................................................................. 7!

2.4! Usage!Scenarios .......................................................................................................................................... 7!

2.4.1! Usage!Scenario:!Registration!of!Data!Providers!and!Data!Users!in!the!EHR4CR!System .................... 7!

2.4.2! Usage!Scenario:!Defining!the!Conditions!for!Data!Provision!and!Use................................................. 7!

2.4.3! Usage!Scenario:!Preparing!EHR!Data!for!Use!by!EHR4CR.................................................................... 8!

2.4.4! Usage!Scenario:!Paying!for!Services!and!Generating!Revenue ......................................................... 10!

2.4.5! Usage!Scenario:!Advertising!clinical!trials!on!the!EHR4CR!platform ................................................. 11!

2.4.6! Usage!Scenario:!Advertising!“interest”!in!clinical!research!participation ......................................... 11!

2.4.7! Usage!Scenario:!Governance!of!Actors!Involved!in!Provision!and!Use!of!Data................................. 12!

3! Domain!Scenario:!Protocol!Feasibility............................................................................................................... 13!

3.1! Scenario!Overview..................................................................................................................................... 13!

3.2! Scenario!Details ......................................................................................................................................... 13!

3.2.1! Risk!Analysis ...................................................................................................................................... 13!

4! Domain!Scenario:!Patient!Identification!and!Recruitment ............................................................................... 14!

4.1! Problem!Statement ................................................................................................................................... 14!

4.2! Domain!Scenario!Overview ....................................................................................................................... 14!

4.2.1! Scenario!Purpose/Objectives ............................................................................................................ 14!

4.2.2! Scenario!Description.......................................................................................................................... 14!

4.3! Domain!Scenario!Details ........................................................................................................................... 15!

4.3.1! Setting ............................................................................................................................................... 15!

4.3.2! Current!State ..................................................................................................................................... 15!

4.3.3! Future!Ideal!State .............................................................................................................................. 18!

4.3.4! Issues/Challenges .............................................................................................................................. 20!

4.3.5! Future!Extensions .............................................................................................................................. 20!

4.3.6! Actors!and!their!Roles!and!Responsibilities ...................................................................................... 20!

4.3.7! Expected!Benefits.............................................................................................................................. 21!

4.3.8! Assumptions!and!Constraints............................................................................................................ 21!

4.3.9! Risk!Analysis ...................................................................................................................................... 22!


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4.4! Usage!Scenarios!for!Patient!Identification!and!Recruitment .................................................................... 23!

4.4.1! Usage!Scenario:!Authorizing!Participation!and!Granting!Access....................................................... 24!

4.4.2! Usage!Scenario:!Reùsing!Trial!Specific!Queries................................................................................ 24!

4.4.3! Usage!Scenario:!Identifying!Potential!Candidates............................................................................. 24!

4.4.4! Usage!Scenario:!Contacting!Treating!Physicians ............................................................................... 24!

4.4.5! Usage!Scenario:!Evaluating!Patients ................................................................................................. 25!

4.4.6! Usage!Scenario:!Managing!Recruitment ........................................................................................... 25!

5! Domain!Scenario:!Clinical!trial!Data!Exchange .................................................................................................. 26!

6! Domain!Scenario:!Adverse!Event!reporting ...................................................................................................... 26!

Appendix!1:!Definitions/List!of!Terms....................................................................................................................... 27!

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1 INTRODUCTION This!document!describes!the!scenarios!for!the!EHR4CR!system!when!delivering!services!for!a!clinical!trial.!These!scenarios!are!used!for!informing!the!requirements!development!process.!

The!scenarios!cover!5!domains:!

• General!

• Protocol!Feasibility!

• Patient!Identification!and!Recruitment!

• Clinical!Trial!Data!Exchange!

• Adverse!Event!Reporting!

Each!domain!scenario!has!been!broken!down!into!lower!level!‘Usage!Scenarios’.!Together!they!describe!the!critical!business!interactions!(the!goals,!motivations,!inputs,!steps,!events,!and/or!actions!which!occur!during!the!interaction)!with!enough!detail!to!indicate!their!anticipated!operation!for!the!delivery,!control!and!use!of!each!EHR4CR!service.!

The!current!status!of!scenario!development!is!summarised!in!Table!1.!

Table 1: Summary of Domain and Usage Scenario Development

Domain(Scenario( +

+

Usage+Scenario+ +

General+ Protocol(Feasibility+

Patient(Identification(and(

Recruitment+

Clinical(Trial(Data(Exchange+

Adverse(Event(Reporting+

Domain scenario description and

storyboard Planned

V1.4 released internally

September 2011


January 2013

Planned

starts February 2013

Planned

starts Q4 2013

Registration of Data Providers and Data Users in the EHR4CR System

Planned

Defining the Conditions for Data Provision and Use

Planned

Preparing EHR Data for Use by EHR4CR


September 2011

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Using EHR4CR Compliant Data for Service Provision


September 2011


January 2013

Planned

starts February 2013

Planned

starts Q4 2013

Governance of Actors Involved in Provision and Use of Data

First Content

Paying for Services and Generating Revenue

Planned

Advertising “interest” in clinical research participation

First Content


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Domain(Scenario( +

+

Usage+Scenario+ +

General+ Protocol(Feasibility+

Patient(Identification(and(

Recruitment+

Clinical(Trial(Data(Exchange+

Adverse(Event(Reporting+

Advertising clinical trials on the EHR4CR platform

First Content

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1.1 HOW TO READ THIS DOCUMENT This!document!will!develop!into!the!complete!list!of!scenarios!for!the!EHR4CR!Platform!and!Business!Model.!!

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7! Domain+Scenario:+General++ Project(Confidential(!

!2 DOMAIN SCENARIO: GENERAL

Defining(the(core(components(of(the(EHR4CR(platform(and(business(model.(

2.1 PROBLEM STATEMENT <>!

2.2 DOMAIN SCENARIO OVERVIEW <>!

2.3 DOMAIN SCENARIO DETAILS

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2.4 USAGE SCENARIOS The!following!usage!scenarios!are!relevant!for!this!domain:!

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2.4.1 USAGE SCENARIO: REGISTRATION OF DATA PROVIDERS AND DATA USERS IN THE EHR4CR SYSTEM

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2.4.1.1 SCENARIO PURPOSE/OBJECTIVES To!describe!the!conditions!to!be!met!for!registration!of!Data!Providers!and!Data!Users!in!the!EHR4CR!system.!

2.4.1.2 SCENARIO DESCRIPTION To!be!developed!in!future!versions!

2.4.2 USAGE SCENARIO: DEFINING THE CONDITIONS FOR DATA PROVISION AND USE

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2.4.2.1 SCENARIO PURPOSE/OBJECTIVES

General!Registralon!of!Data!

Providers!and!Data!Users!in!the!EHR4CR!System!

Defining!the!Condilons!for!Data!Provision!

and!Use!

Preparing!EHR!Data!for!Use!by!EHR4CR!!

Paying!for!Services!and!Generalng!Revenue!!

Adverlsing!clinical!trials!

on!the!EHR4CR!planorm!

Adverlsing!“interest”!in!

clinical!research!

parlcipalon!

Governance!of!Actors!Involved!in!

Provision!and!Use!of!Data!


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2.4.3 USAGE SCENARIO: PREPARING EHR DATA FOR USE BY EHR4CR

2.4.3.1 SCENARIO PURPOSE/OBJECTIVES To!evaluate!the!potential!for!data!provision,!to!identify!the!gaps!and!to!undertake!the!necessary!steps!to!prepare!the!data!in!an!EHR4CR!compatible!format!so!that!it!can!be!used!by!EHR4CR!services.!

2.4.3.2 SCENARIO DESCRIPTION In!this!usage!scenario!EHR!data!is!made!accessible!for!later!searching!by!users!of!the!EHR4CR!platform.!The!typical!user!stories!for!this!scenario!are:!

• As!a!Sponsor!(‘Data!User’),!I!want!to!be!able!to!ensure!that!the!data!I!will!need!for!EHR4CR!clinical!trial!services!will!be!available!in!a!large!enough!volume!(number!of!patients!and/or!items)!and!quality!(key!data!fields!present)!so!that!I!can!search!accessible!data!using!EHR4CR!services!in!order!to!evaluate!patient!populations!for!protocol!feasibility,!to!optimise!protocol!design!and!to!identify!sites!with!access!to!patient!populations!that!fit!protocol!inclusion/exclusion!criteria.!

Note:(Data(Users(will(specify(required(data(conditions(for(specified(uses(within(the(usage(scenario:(Defining(the(Criteria(for(Data(Provision(and(Use(

• As!a!Healthcare!Site!providing!EHR!data!or!providing!access!to!EHR!data!(‘Data!Provider’),!I!want!to!be!able!to!evaluate!the!effort!required!to!prepare!data!for!access!by!EHR4CR!services,!the!steps!I!need!to!go!through!to!make!it!happen!and!the!potential!revenue!I!can!generate!so!that!I!can!understand!the!ROI.!

As!part!of!this!scenario:!

• Data!Provider!can!access!EHR4CR!data!provision!conditions!for!EHR4CR!compatibility!in!order!to!selfàssess:!

o Process!steps!to!be!undertaken!

o Data!volume!and!quality!required!for!the!intended!service(s)!

o Potential!revenue!

o Revenue!enhancement!options!(e.g.!how!revenue!is!linked!to!expansion!of!data!volume,!improvement!in!data!quality,!or!expansion!of!potential!uses)!

• Data!Provider!can!access!EHR4CR!tools!to!aid!in!the!preparation!of!the!data!subset!for!use!by!EHR4CR!services!(e.g.!filtering,!anonymisation,!transformation!to!a!standard!format!and!structure!compliant!with!EHR4CR!conditions).!

• EHR4CR!validates!the!Data!Provider!(part!of!the!Governance!scenario)!and!quality!controls!the!data!provision!to!ensure!conformance!with!EHR4CR!conditions!before!data!is!released!for!use!by!EHR4CR!services.!

• Data!Provider!can!authorise!release!of!data!for!use!by!specified!EHR4CR!services,!so!that!Data!Provider!retains!ownership!of!the!data!and!can!remove!permission!for!use!at!any!


!


time!or!at!pre`defined!intervals!(to!be!defined!whether!this!should!be!on!demand!or!at!fixed!intervals!e.g.!annually)!

• The!revenue!model!encourages!Data!Provider!to!increase!the!data!volume,!completeness,!quality!and!intended!uses!(part!of!the!Paying!for!Services!and!Generating!Revenue!scenario!in!2.4.4)!

• Provided!data!can!be!updated!at!specified!intervals!based!upon!intended!use.!!

Note:(Data(is(updated(by(adding(relevant(new(records,(updating(record(fields(and(deleting(no(longer(appropriate(records(so(that(the(dataset(being(used(by(EHR4CR(services(remains(contemporaneous.(This(may(or(may(not(require(a(physical(operation(depending(on(the(implementation(chosen,(e.g.(access(to(a(copy(of(the(data(would(require(regular(updates,(querying(via(an(interface(into(the(EHR(system(may(not.(For(Protocol(Feasibility(the(update(frequency(may(be(low((e.g.(monthly(or(quarterly)(whereas(other(services,(such(as(Patient(Identification(and(Recruitment,(may(require(even(daily(or(weekly(updates(in(order(to(capture(data(on(recent(patients.(

• As!a!Data!Protection!Manager/Officer!(‘Data!Controller’),!I!want!to!be!able!to!ensure!that!Data!Providers!retain!ownership!of!data!provided!for!access!and!that!accessible!data!meets!appropriate!requirements!for!reliability,!ethics!and!data!protection!(e.g.!data!is!deìdentified,!comes!from!a!known!and!reliable!source,!is!of!known!history!and!processes!and!systems!are!‘fit!for!purpose’).!

2.4.3.3 EXTENSIONS (ALTERNATE FLOWS) • Data!Provider!decides!to!remove!permission!for!access!to!their!EHR!data!for!a!particular!

service.!As!a!result,!the!site!will!no!longer!be!selectable!for!searching!as!part!of!the!service,!their!data!will!not!be!used!in!provision!of!this!service,!components!as!part!of!the!sites!participation!in!provision!of!the!service!will!be!locked.!

• Data!Provider!or!EHR!System!fails!EHR4CR!validation!e.g.!has!not!been!qualified!/!certified!or!fails!the!qualification/certification!process.!In!this!scenario!the!data’s!provenance,!history!and!reliability!is!questionable!and!data!will!not!be!released!for!use!by!EHR4CR!services!until!conditions!for!release!are!met.!

• Data!to!be!made!accessible!to!EHR4CR!services!fails!EHR4CR!quality!control!e.g.!data!quality!is!too!low!and/or!key!fields!are!missing.!In!this!scenario!the!minimum!data!elements!required!for!use!by!EHR4CR!services!are!not!present!and!the!data!will!not!be!released!for!use!by!EHR4CR!services.!

2.4.3.4 ISSUES AND CHALLENGES The!following!problems!and!challenges!are!related!this!scenario:!

• <>!!

2.4.3.5 EXPECTED BENEFITS The!following!benefits!are!expected!as!a!result!of!this!scenario:!

• Data!Providers!will!be!able!to!determine!the!gap!and!corrective!actions!to!take!to!maximise!compatibility!of!their!proposed!shared!data!with!requirements!from!EHR4CR!

• Data!Providers!will!be!rewarded!for!data!provision!based!upon!volume,!quality!and!intended!use!and!will!be!encouraged!to!maximise!these!parameters.!


!


• Systems!providing!data!will!conform!to!a!set!of!non`functional!requirements!that!ensure!the!reliability!of!accessible!data!and!conformance!with!defined!data!access!principles!(to!be!defined!in!domain!scenarios!for!individual!services).!

• EHR!systems!will!be!adapted!to!optimise!data!sharing!and!the!updating!of!shared!data!for!EHR4CR!

• Data!Providers!will!retain!their!ownership!and!control!of!shared!data!

• Actors!and!processes!will!be!qualified/certified!ensuring!that!data!privacy!and!data!reliability!standards!are!met!(and!seen!to!be!met)!and!maintained!(to!be!defined!in!usage!scenario:!Governance!Of!Actors!Involved!In!Provision!And!Use!Of!Data)!

QUANTIFICATION OF BENEFITS • Key!Performance!Indicators!(KPIs)!and!evaluation!criteria!will!be!developed!during!the!

project!lifetime!in!task!1.5.!

2.4.3.6 ASSUMPTIONS AND CONSTRAINTS The!following!assumptions!have!been!made!for!this!scenario:!

• Patient!consent!is!not!needed!or!given!for!secondary!use!of!deìdentified!data!by!EHR4CR!Protocol!Feasibility!and!Patient!Identification!and!Recruitment!services.!

• Patient!consent!is!needed!and!given!for!secondary!use!of!pseudoànonymised!data!by!EHR4CR!Clinical!Trial!Data!Exchange!and!Adverse!Event!Reporting!services.!

• Natural!Language!Processing!will!not!be!used!to!extract!data!or!to!generate!structured!data.!

• The!language!of!initial!tools,!interfaces!and!reports!will!be!in!English.!

2.4.3.7 RISK ANALYSIS The!following!table!summarizes!the!risks!that!have!been!identified!for!this!scenario.!

Table 2: Summary of Risk Assessment

Service'Component'or'Process'

Hazard'or'Potential'Event'

Potential'Consequence'

Proactive Actions(recommended(

to(lower(the(risk

Reactive'Actions(to(be(taken(if(

event(occurs(

General Anonymisation!does!not!work!100!%!

Data is documented with different codes/units that cannot be converted

!

2.4.4 USAGE SCENARIO: PAYING FOR SERVICES AND GENERATING REVENUE

2.4.4.1 SCENARIO PURPOSE/OBJECTIVES To!describe!the!conditions!for!cost!and!revenue!management!services.!



!


2.4.5 USAGE SCENARIO: ADVERTISING CLINICAL TRIALS ON THE EHR4CR PLATFORM

A(Sponsor(can(advertise(clinical(trials(on(the(platform(to(find(sites(that(are(interested(to(participate(in(clinical(trials.(

2.4.5.1 SCENARIO PURPOSE/OBJECTIVES The!Sponsor!of!a!clinical!trial!might!be!interested!to!promote!clinical!trials!on!the!platform!to!find!sites!that!are!interested!to!participate!in!a!clinical!trial.!One!reason!might!be!that!inclusion!and!exclusion!criteria!to!find!patients!with!a!specific!pathology!cannot!be!transformed!into!an!adequate!EHR4CR!query!due!the!complexity!or!the!specificity!of!the!eligibility!criteria.!

2.4.5.2 SCENARIO DESCRIPTION <>.!

2.4.5.3 ACTORS AND THEIR ROLES AND RESPONSIBILITIES

HUMAN ACTORS • Sponsor!

• Site/Hospital!staff,!such!as!Treating!Physicians!

COMPUTER ACTORS • EHR!systems,!

• EHR4CR!platform,!in!the!role!of!provider!of!clinical!trial!promoting!services.!The!EHR4CR!platform!is!responsible!for!making!the!necessary!tools!and!services!available!for!promoting!the!interest!of!sites!to!participate!in!clinical!trials.!

2.4.6 USAGE SCENARIO: ADVERTISING “INTEREST” IN CLINICAL RESEARCH PARTICIPATION

A(site(or(a(department(of(a(site(may(want(to(“advertise”(their(interest(to(participate(in(clinical(trials.(

2.4.6.1 SCENARIO PURPOSE/OBJECTIVES The!site!may!report!following!in!the!EHR4CR!platform:!

• The!presence!/!availability!of!a!number!of!patients!with!a!given!pathology!

• The!presence!/!availability!of!a!number!of!patients!treated!in!a!department!with!experience!in!conducting!clinical!trials!

2.4.6.2 SCENARIO DESCRIPTION The!Sponsor!initiating!a!trial!can!then!as!first!step!be!informed!on!the!sites!that!advertised!interest!in!conducting!a!trial!related!to!the!domain.!!

The!typical!user!stories!for!this!scenario!are:!

• As!a!trial!Sponsor,!I!want!to!find!sites!that!are!interested!and!eligible!to!participate!in!specific!clinical!trial.!

• As!a!Data!Provider,!I!want!to!be!able!share!or!to!promote!my!interest!to!participate!in!clinical!trials.!


!


To!be!developed!in!future!versions.!

2.4.6.3 ACTORS AND THEIR ROLES AND RESPONSIBILITIES

HUMAN ACTORS • Site/Hospital!staff,!such!as!Treating!Physicians!

• Sponsor.!

COMPUTER ACTORS • EHR!systems,!

• EHR4CR!platform,!in!the!role!of!provider!of!clinical!trial!promoting!services.!The!EHR4CR!platform!is!responsible!for!making!the!necessary!tools!and!services!available!for!promoting!the!interest!of!sites!to!participate!in!clinical!trials.!

2.4.6.4 EXPECTED BENEFITS The!following!benefits!are!expected!as!a!result!of!this!scenario:!

• This!will!enable!–!in!some!cases!–!to!avoid!a!long!feasibility!process.!

2.4.7 USAGE SCENARIO: GOVERNANCE OF ACTORS INVOLVED IN PROVISION AND USE OF DATA

2.4.7.1 SCENARIO PURPOSE/OBJECTIVES To!describe!the!conditions!to!be!met!for!governance!of!the!EHR4CR!system!and!actors.!


• Certification!and!qualification!

• Ombudsman!role!

• Contracting!

• Monitoring!of!use!of!EHR4CR!platform!

• Control!of!EHR4CR!network!

• Maintenance!of!platform!specifications!

• Auditing!

• Risk!evaluation!and!management!

• Training!

• Help!desk!services!

• Management!of!service!providers,!!Data!Providers!!and!Data!Users!

• <>!

!

!


!

13! Domain+Scenario:+Protocol+Feasibility++ Project(Confidential(!

3 DOMAIN SCENARIO: PROTOCOL FEASIBILITY Evaluating(patient(populations(to(assist(in(the(feasibility(assessment(and(protocol(design(of(a(new(clinical(trial(by(querying(EHR(databases(for(patient(populations(that(meet(preOdefined(inclusion/exclusion(criteria.(

3.1 SCENARIO OVERVIEW Described!in!a!separate!document!<<Protocol!Feasibility!Requirement!Scenarios!V1_4!20110930.docx>>!released!September!2011.!!

3.2 SCENARIO DETAILS

Described!in!a!separate!document!<<Protocol!Feasibility!Requirement!Scenarios!V1_4!20110930.docx>>!released!September!2011.!!

3.2.1 RISK ANALYSIS The!following!table!summarizes!the!risks!that!have!been!identified!for!this!scenario.!






to(lower(the(risk


event(occurs(

General None

Run Protocol Feasibility Query

Query being run for unauthorised activity

Loss of confidence in system governance Data Providers withdraw access to their data

Report to allow monitoring of query use by a Trusted Third Party (TTP).

Contract terms between EHR4CR and Data User concerning appropriate use

User can be warned and then removed from EHR4CR approved users if inappropriate use continues

Run Protocol Feasibility Query

Query shared with an individual outside those authorised by owner

Company confidential information in PF query available to non-authorised individuals

Loss of confidence in platform and process

Query owner can see at a glance who the query has been shared with, when it was last run and by who

Site Selection User needs to identify site contact during the site selection process but contact details missing

New scenario System holds metadata on who to contact at site for selected diagnosis/therapeutic area

Contact details are mandatory

Update feature to notify Sponsor as soon as contact details are entered

Site Selection User needs to identify sites wanting to participate during site

New scenario System holds metadata on which sites are advertising for trials in

Promote functionality for sites to advertise


!

14! Domain+Scenario:+Patient+Identification+and+Recruitment++ Project(Confidential(!





to(lower(the(risk


event(occurs(

selection process patient populations with diagnosis or Therapeutic area

their interest

4 DOMAIN SCENARIO: PATIENT IDENTIFICATION AND RECRUITMENT Identifying(patients(for(Clinical(Trials(to(confirm(patient(eligibility(and(to(facilitate(their(clinical(trial(enrolment(by(searching(existing(EHRs(database.(

4.1 PROBLEM STATEMENT Establishing!the!safety!and!efficacy!of!new!drugs!requires!treating!patients!under!very!controlled!conditions!in!Phase!II!and!III!CTs.!!

Incredibly!though,!50%!of!trials!fail!to!achieve!the!projected!recruitment!rate,!despite!the!industry’s!best!efforts!to!establish!achievable!targets!for!patient!recruitment.!

The!impact!of!getting!it!wrong!can!be!significant:!

• Extended!recruitment!periods!and!delays!in!trial!completion!

• Recruitment!of!extra!sites!to!compensate!for!low!performers!

• Modifications!in!trial!design!(protocol!amendments)!

In!the!best!case,!failure!to!achieve!recruitment!targets!creates!a!lot!of!rework,!delays!in!decision`making!and!changes!to!subsequent!development!strategies!that!are!based!on!the!expected!availability!of!results.!In!the!worst!case,!the!failure!may!result!in!abandonment!of!the!trial,!but!fortunately!this!is!rare.!

Patient!recruitment!therefore!remains!one!of!the!biggest!challenges!for!Pharma.!Studies,!however,!show!that!a!manual!process!to!search!for!potential!candidates!misses!27%!of!suitable!candidates!compared!with!electronic!searching.!Tools!to!support!searching!of!electronic!health!records!therefore!have!the!potential!to!significantly!enhance!the!reliability!of!recruitment!predictions!and!the!identification!of!potential!clinical!trial!candidates.!

4.2 DOMAIN SCENARIO OVERVIEW

4.2.1 SCENARIO PURPOSE/OBJECTIVES To!evaluate!patient!populations!via!the!EHR4CR!platform!with!the!goal!of!identifying!local!Treating!Physicians!and!patient!candidates!for!a!given!clinical!research!trial!based!upon!their!fit!with!the!requirements!of!the!clinical!research!protocol.!

4.2.2 SCENARIO DESCRIPTION In!this!scenario!users!are!searching!for!local!Treating!Physicians!with!access!to!a!defined!patient!population!and!for!patients!that!are!eligible!for!participation!in!a!planned!clinical!research!trial.!!

The!typical!user!stories!for!this!scenario!are:!

• As!an!Investigator,!I!want!to!be!able!to!access!local/regional!shared!EHR!data!in!order!to:!

o Identify!suitable!existing!patients!that!meet!selected!inclusion/!exclusion!criteria!for!a!Clinical!Trial!(e.g.!within!range!for!age,!indication/diagnosis,!co`meds,!lab!values)!and!


!


with!an!appropriate!status!(e.g.!are!willing!to!participate!in!a!clinical!trial;!aren’t!currently!participating!in!a!Clinical!Trial,!etc.)!

o Identify!the!Treating!Physician!and!patient!identifiers!so!that!the!patient!can!be!evaluated!further!!and!contacted!if!appropriate!

o Identify!new!patients!that!meet!criteria!through!automated!execution!of!the!query.!

• As!a!Sponsor,!I!want!to!be!able!to!support!investigational!sites!by!pre`populating!queries!and!templates!with!trial!specific!information!for!sites!selected!and!preparing!for!patient!recruitment.!

4.2.2.1 NOT INCLUDED IN THIS SCENARIO As!a!future!user!story:!

• As!a!patient,!I!want!to!be!able!to!register!my!interest!or!my!disinterest!in!being!contacted!about!participation!in!clinical!research!trials!

The!following!are!not!included!in!this!scenario:!

• Identify!new!patients!that!meet!criteria!either!by!near!real`time!flagging!of!patient!candidates.!This!option!will!be!difficult!to!achieve!and!instead!the!process!will!rely!on!re`running!the!defined!query!at!specified!intervals.!

• Automated!reporting!of!patient!recruitment!status!at!the!site!level.!This!option!will!require!consolidated!status!information!to!be!pushed!to!the!central!EHR4CR!platform!for!access!by!Sponsors!and!is!not!considered!to!be!essential!functionality!at!this!time.!

4.3 DOMAIN SCENARIO DETAILS

4.3.1 SETTING The!setting!for!the!Patient!Identification!and!Recruitment!domain!scenario!is:!

• The!Principal!Investigator!needs!to!confirm!potential!patient!numbers!to!the!trial!Sponsor!for!site!selection!and!recruitment!planning!decisions!and!to!the!Ethics!Committee!to!confirm!the!achievability!of!patient!recruitment!targets.!

• A!Principal!Investigator/Research!Nurse!needs!to!identify!local!patient!candidates!for!a!clinical!trial!that!meet!protocol!inclusion/exclusion!criteria!so!that!patients!can!be!contacted!for!participation!in!the!trial.!This!may!also!require!the!Research!Physician!to!reach!out!to!local!Treating!Physicians!for!candidates/referrals.!

• The!Principal!Investigator!needs!to!inform!the!trial!Sponsor!of!recruitment!progress!in!order!to!monitor!achievement!of!expectations!and!to!allow!proactive!and!reactive!actions!in!the!event!of!significant!variance.!

4.3.2 CURRENT STATE The!current!process!for!identifying!suitable!patient!candidates!and!recruiting!them!to!a!clinical!trial!goes!through!a!sequence!of!steps:!

1. Recruitment!planning!

2. Identification!of!patient!candidates!

3. Contacting!Treating!Physicians!for!referrals!

4. Recruiting!patients!


!


5. Managing!recruitment!!

4.3.2.1 STEP 1: RECRUITMENT PLANNING The!objective!is!to!ascertain!the!recruitment!potential!of!an!individual!site!and!to!develop!site!

specific!recruitment!plans.!At!this!stage!the!site!has!not!been!definitively!selected!for!

participation.!In!order!to!set!expectations!and!to!plan!recruitment!strategy!for!the!site,!each!

Research!Physician!will!be!asked!for!the!number!of!suitable!patients!found!during!a!local!search!

that!meet!the!protocol!inclusion/exclusion!criteria!who!either:!

• Are!already!registered!with!the!site!and!likely!to!be!available!for!recruitment!into!the!trial!

(for!chronic!disease!indications).!

• Were!previously!seen!in!a!specified!time!period!e.g.!previous!12!months!(for!acute!

disease!indications).!

The!information!is!obtained!by!the!site!in!the!best!case!via!a!manual!search!of!hospital!records,!

but!more!likely!just!Research!Physician!memory.!The!reliability!of!the!number!is!not!known!–!i.e.!

the!method!for!obtaining!and!the!accuracy!of!the!fit!with!protocol!inclusion/exclusion!criteria!is!

unknown.!Normally!the!number!is!based!on!Research!Physician!experience!and!may!not!take!

into!account!suitable!candidates!being!seen!by!other!Treating!Physicians.!!

Experienced!Research!Physicians!or!central!Clinical!Trial!Units!may!provide!more!reliable!figures!

drawn!from!a!self`maintained!spread!sheet!or!database.!In!only!rare!cases!will!the!Research!

Physician!or!Research!Nurse!be!able!to!query!local!records!directly!(e.g.!using!online!tools!

querying!electronic!health!records)!in!order!to!obtain!hard!numbers!of!potential!patients.!Even!

when!such!tools!are!available,!within!any!one!region!multiple!platforms!may!be!involved,!so!that!

each!query!has!to!be!different.!Whether!the!number!is!produced!by!rule!of!thumb,!manual!

search!of!records!or!using!online!querying!tools,!each!site!may!therefore!use!different!selection!

criteria!making!the!reliability!of!the!final!results!questionable.!

The!problem!is!that!there!is!little!incentive!for!the!site!to!provide!reliable!numbers:!

• Hospital!records!are!still!heavily!paper`based!and!it!therefore!takes!effort!to!manually!

trawl!records!

• Sites!are!not!paid!for!this!effort!

• At!this!stage!there!is!no!guarantee!that!the!site!will!be!selected!for!participation!in!the!

trial!

In!some!settings!where!there!is!a!central!research!coordinator,!this!early!process!may!also!

identify!Treating!Physicians!that!can!then!be!contacted!to!evaluate!their!capability!and!their!

interest!in!contributing!to!the!research!protocol.!

This!information!is!used!by:!

• Sponsor!staff!to!be!able!to!develop!recruitment!plans!at!the!site!level.!

• Some!sites!as!part!of!the!Ethics!Committee!submission!process!(e.g.!Germany,!France)!

where!the!local!EC!wants!to!ensure!that!the!Investigator!is!qualified!to!participate!and!

can!deliver!the!required!number!of!patients.!

• Research!Physician!as!part!of!the!funding!stage!discussions.!

4.3.2.2 STEP 2: IDENTIFICATION OF PATIENT CANDIDATES


!


The!objective!is!to!identify!suitable!individual!patient!candidates!for!the!trial.!The!Research!

Physician!draws!upon!knowledge!of!patients!within!their!care!that!may!be!candidates!that:!

• Are!already!known!to!the!Research!Physician!or!colleagues,!who!potentially!meet!

inclusion/exclusion!criteria,!who!will!consider!participation!into!a!trial.!Patients!may!be!

discharged!and!not!attending!outpatient!clinics!or!may!be!attending!regular!outpatient!

clinics!(for!chronic!disease!indications).!

• Are!acute!admissions!presenting!with!the!correct!inclusion/exclusion!criteria!(for!acute!

disease!indications).!

Normally!identification!of!patient!candidates!occurs!only!within!the!Research!Physician’s!

immediate!care!pool!and!only!once!the!trial!is!initiated.!For!chronic!diseases!where!the!patients!

have!preèxisting!records!and!are!attending!regular!outpatient!clinics,!it!may!be!possible!for!the!

Research!Physician!to!preìdentify,!evaluate!and!approach!patient!candidates.!!

The!Research!Nurse!may!scan!patient!records!for!outpatient!clinics!to!identify!potential!trial!

candidates!that!the!Treating!Physician!should!evaluate!and!refer!on!to!the!Research!Physician!if!

they!meet!the!protocol!criteria!and!show!willingness!for!further!evaluation!and!information.!!

The!problem!is!that!busy!clinics!may!have!a!number!of!clinical!trials!going!on!(and!with!only!slight!

variations!in!inclusion/exclusion!criteria)!and!it!is!difficult!for!a!Treating!Physician!to!know!the!

best!trial!for!a!patient.!Some!companies!provide!“crib!sheets”!for!the!site!to!use.!

Except!in!rare!instances,!the!Treating!Physician!is!the!only!person!with!the!knowledge!about!

whether!a!patient!is!willing/not!willing!to!be!contacted!for!participation!within!a!trial.!!

Note.(Some(sites(do(use(existing(tools(to(access(healthcare(data(electronically(for(Patient(Identification(and(Recruitment(purposes.(Within(the(data(accessed(by(the(Farsite(system(used(in(Salford(UK,(there(is(a(flag(that(can(be(set(by(the(Treating(Physician((and(only(the(Treating(Physician)(if(the(patient(is(inappropriate(for(participation(in(a(clinical(trial(or(has(requested(not(to(be(contacted((currently(only(used(in(primary(care).(Other(users(of(the(Farsite(system(simply(get(results(returned(that(don’t(include(such(patients.!

4.3.2.3 STEP 3: CONTACTING TREATING PHYSICIANS FOR REFERRALS The!objective!is!to!boost!recruitment!potential!by!collaborating!with!other!Treating!

Physicians/care!routes.!

• Normally!other!Treating!Physicians/other!departments!are!only!contacted!if!recruitment!

rate!is!not!being!achieved.!Colleagues!may!not!always!want!to!participate.!Getting!them!

involved!requires!personal!contact!–!a!15!min!talk!on!the!protocol.!Some!research!centres!

have!research!meetings!once!a!week!where!trial!needs!can!be!discussed.!

• Trial!patients!may!come!from!a!number!of!care!pathways!e.g.!general/geriatric!wards!

4.3.2.4 STEP 4: RECRUITING PATIENTS

KNOWN CANDIDATES The!hospital!records!for!candidates!are!evaluated!by!the!Treating!Physician!and!only!suitable!

patients!are!contacted!for!participation.!Even!if!the!patient!candidates!are!identified!via!a!

structured!spread!sheet!or!database,!there!is!no!automated!link!to!the!hospital!records,!so!these!

have!to!be!retrieved!manually.!Even!the!limited!querying!of!existing!health!records!that!may!be!

possible!today!e.g.!age!and!thyroxin!levels,!can!save!time.!


!


ACUTE ADMISSIONS Certain!protocols!will!require!identification!of!patients!as!they!come!through!the!door!for!treatment!within!a!small!time!window.!Recruitment!of!these!patients!is!primarily!through!awareness!of!Treating!Physicians!that!a!suitable!trial!is!on`going!and!knowing!who!they!should!contact.!!

4.3.2.5 STEP 5: MANAGING RECRUITMENT The!objective!is!to!ensure!that!recruitment!potential!is!achieved.!

Members!of!the!Sponsor’s!clinical!trial!team!or!monitoring!staff!will!monitor!recruitment!versus!expectations!in!order!to!take!early!action!if!needed!to!maximize!recruitment!potential.!Where!recruitment!is!at!variance!with!the!site!recruitment!plan!appropriate!actions!may!be!needed!to!correct!the!situation.!!

4.3.3 FUTURE IDEAL STATE

4.3.3.1 OBJECTIVES The!future!ideal!process!for!identifying!suitable!patient!candidates!and!recruiting!them!to!a!clinical!trial:!

• Will!make!information!available!faster!!

• Will!facilitate!site!identification!of!candidates!

• May!increase!the!number!of!identified!candidates!(i.e.!candidates!are!missed!in!today’s!memory/manual!process)!

4.3.3.2 WORKFLOW: The!following!figure!summarises!the!anticipated!future!workflow.!


!


!

Figure 1: Workflow for the Patient Identification and Recruitment Process

Within!this!workflow:!

• Sponsor!develops!a!query!that!includes!a!complete!list!of!inclusion/exclusion!criteria.!This!query!is!stored!within!the!trial|country!folder!for!reùse!within!the!site!level!Patient!Identification!and!Recruitment!process.!

• Sponsor!prepares!study!information!(per!country)!that!will!be!required!by!Research!Physician!for!the!patient!recruitment!process!(templates,!tool!kits).!This!information!is!stored!within!the!trial|country!folder.!

• Sites!selected!to!participate!in!the!trial!are!granted!access!to!the!trial|country!folder.!

• Site!runs!query!on!local!data:!!

o Special!privileges!allow!Research!Nurse!to!see!numbers!of!patients!by!Treating!Physician.!!

o When!user!is!the!Treating!Physician,!individual!patients!are!shown.!The!Treating!Physician!can!elect!to!deìdentify!patient.!Within!a!future!scenario,!the!user!can!link!to!the!patient’s!hospital!record!in!order!to!fully!evaluate!suitability.!

o Treating!physician!can!evaluate!which!patients!to!contact!for!participation.!Within!a!future!scenario,!the!Treating!Physician!can!flag!those!that!are!never!appropriate!


!


or!have!requested!not!to!be!contacted.!These!patients!are!then!excluded!from!subsequent!site!level!searches!(but!are!still!included!in!feasibility!reports)!

o Treating!physician!details!are!sufficient!to!allow!Research!Physician!/!Research!Nurse!to!contact!Treating!Physician!

• The!system!tracks!who!was!contacted,!when!and!subsequent!actions!(e.g.!response).!

• For!chronic!diseases,!trial!patients!can!be!preìdentified.!This!allows!recruitment!to!proceed!briskly!once!site!is!initiated!

• To!catch!recent/acute!admissions:!

o Query!rerun!at!regular!intervals!to!identify!new!admissions!(is!frequency!set!by!Research!Physician!locally?)!

o System!sends!automatic!reminder!to!selected!Treating!Physicians!at!regular!intervals!

o In!a!future!extension,!potential!patient!candidates!being!entered!into!the!hospital!EHR!system!are!flagged!dynamically!

4.3.4 ISSUES/CHALLENGES The!following!issues/challenges!have!been!identified!for!this!scenario:!

• The!correct!way!to!handle!missing!data.!Potential!candidates!should!not!be!eliminated!from!returned!results!if!subsidiary!data!is!missing!to!answer!a!query!criterion!because!the!information!may!be!available!within!the!patient!record!(but!is!just!unavailable!for!use!by!EHR4CR).!!

4.3.5 FUTURE EXTENSIONS To!be!considered!for!future!iterations:!

• A!flag!is!set!against!a!patient!within!an!EHR!system!to!show!that!they!are!potential!candidates!for!one!or!more!on`going!trials!

• A!flag!is!set!for!a!patient!that!has!been!enrolled!within!a!trial!so!that!it!is!possible!to!monitor!the!efficiency!of!different!pathways!to!recruitment!

• The!EHR!system/EHR4CR!records!patients!that!the!Treating!Physicians!considers!inappropriate!for!contact!for!participation!

• The!EHR!system/EHR4CR!records!patients!who!have!requested!not!to!be!contacted!for!participation!in!clinical!trials!

4.3.6 ACTORS AND THEIR ROLES AND RESPONSIBILITIES For!detailed!definitions!of!actors,!their!roles!and!responsibilities!please!see!Appendix!1:!Definitions/List!of!Terms.!The!following!sections!simply!list!the!actors!involved!in!this!domain!scenario,!and!the!applicable!roles/responsibilities.!

4.3.6.1 HUMAN ACTORS • Sponsor,!in!the!role!of!clinical!trial!project!manager.!The!Sponsor!is!responsible!for!

applications!to!regulatory!bodies!and!ethics!committees,!identification!of!sites!at!which!the!trial!will!be!held!and!definition!of!the!query!parameters!for!patient!recruitment.!


!


• Research!Physician,!in!the!role!of!Clinical!Trial!Investigator.!The!principle!Investigator!is!responsible!for!supplying!subjects!for!participation!in!the!clinical!trial!and!local!management!and!compliance!of!the!trial!at!the!site.!

• Treating!Physician.!The!Treating!Physician!is!responsible!for!normal!care!provision!to!the!patient!and!is!the!individual!who!can:!

o see!patient!identifying!information!

o assess!the!applicability!of!the!trial!or!any!trial!for!the!patient!

o make!the!initial!contact!with!the!patient!

• Patient,!in!the!role!of!potential!clinical!trial!subject.!The!patient!wants!to!participate!in!a!given!clinical!trial.!

4.3.6.2 COMPUTER ACTORS • EHR!systems,!in!the!role!of!data!repositories.!The!EHR!system!is!responsible!for!making!

the!patient!EHR!data!available!for!scanning!as!part!of!the!patient!recruitment!process.!

• EHR4CR!system,!in!the!role!of!interface!between!the!Sponsor!and!the!Research!Physician.!

4.3.7 EXPECTED BENEFITS The!following!benefits!are!expected!as!a!result!of!this!scenario:!

• Will!make!information!available!faster!!

• Will!facilitate!site!identification!of!candidates!

• May!increase!the!number!of!identified!candidates!(i.e.!candidates!are!missed!in!today’s!memory/manual!process)!

• It!will!be!easier!to!identify!patient!candidates!for!recruitment!

• Potential!patient!numbers!will!be!available!to!improve!reliability!of!patient!recruitment!predictions!and!plans!

• More!suitable!patients!will!be!identified!through!electronic!searching!of!electronic!health!records!

• A!mechanism!is!provided!to!reach!out!to!other!Treating!Physicians!for!patient!referrals!

• Consistent!information!is!available!to!Treating!Physicians!

• Effort!and!costs!will!be!reduced!by:!

o Automating!the!process!for!searching!electronic!records!

o Shortening!the!recruitment!window!

• Reduce!the!number!of!protocol!violations!with!better!fit!of!the!patient!population!

• There!will!be!fewer!protocol!violations!due!to!identification!and!inclusion!of!patients!that!do!not!fulfil!the!inclusion!/!exclusion!criteria.!

QUANTIFICATION OF BENEFITS • KPI!and!evaluation!criteria!will!be!developed!during!the!project!lifetime!in!task!1.5!to!

assess!and!measure!the!patient!recruitment!process.!

4.3.8 ASSUMPTIONS AND CONSTRAINTS


!


The!following!assumptions!have!been!made!for!this!scenario:!

• Patients!do!not!need!to!give!consent!for!their!data!to!be!made!available!for!patient!recruitment!purposes!

• EHR!data!is!relevant!and!of!a!quality!consistent!with!clinical!research!for!the!parameters!being!looked!at!for!patient!recruitment!

• EHR!data!is!available!for!scanning!

• EHR!is!readily!accessible,!i.e.!patient!recruitment!data!is!in!a!common!format!(e.g.!numerical)!!

4.3.9 RISK ANALYSIS The!following!table!summarizes!the!risks!that!have!been!identified!for!this!scenario.!





Proactive'Actions(recommended(

to(lower(the(risk!


event(occurs(

General! Patient!identifying!information!is!leaked!from!system!

System!compromised!Loss!of!confidence!in!system!

Identifying!information!kept!securely!(and!encrypted?)!Expiry!date!on!site!certification/version!of!security!module!is!checked!before!query!is!run!

Local!site/system!moved!offHline!until!security!issue!fixed!


!


!

Share!PF!Query!for!local!identification!of!patient!candidates!

Query!shared!with!an!individual!outside!those!authorised!by!owner!

Company!confidential!information!in!PF!query!available!to!nonHauthorised!individuals!Loss!of!confidence!in!platform!and!process!

Owner!can!see!at!a!glance!who!the!query!has!been!shared!with,!who!is!currently!authorised!to!run!local!versions,!when!last!run!locally!and!by!who!

Site!can!be!warned!and!then!removed!from!EHR4CR!approved!site!if!inappropriate!use!continues!

Run!refined!local!query!

Inappropriate!display!of!patient!identifying!information!to!nonHTreating!Physician!

System!compromised!Loss!of!confidence!in!system!

Issue!reporting!and!management!mechanism!

Monitoring!of!issues!and!issue!management,!change!control!

Evaluate!patient!candidates!for!eligibility!

Local!user!runs!query!without!appropriate!authorisation!(i.e.!Treating!Physician!delegates!to!Research!Nurse)!

User!can!see!identifying!information!when!not!appropriately!authorised!

Treating!Physician!can!temporarily!authorise!another!individual!within!the!system!to!run!query!for!the!trial!on!local!data!using!enhanced!privileges!!

!


Patient!contacted!for!the!trial!despite!not!being!eligible!for!THIS!trial!or!already!in!a!trial!and!should!not!be!contacted!

! Flag!can!be!set!against!patient.!Patient!is!then!excluded!from!subsequent!Recruitment!Query!results!for!the!trial!

!


Patient!reHcontacted!for!trials!despite!Treating!Physician!determining!that!patient!not!!suitable!for!ANY!trial!and!should!not!be!contacted!

! Flag!can!be!set!against!patient.!Patient!is!then!excluded!from!subsequent!Recruitment!Query!results!for!all!trials!

!


Patient!reHcontacted!despite!Patient!request!not!to!be!contacted!for!this!or!future!trials!

! Flag!can!be!set!against!patient.!Patient!is!then!excluded!from!subsequent!Recruitment!Query!results!for!this!or!for!all!trials!

!

!

4.4 USAGE SCENARIOS FOR PATIENT IDENTIFICATION AND RECRUITMENT

The!following!usage!scenarios!are!relevant!for!this!domain:!

!!

Palent!Idenlficalon!and!Recruitment!

Authorizing!Parlcipalon!

and!Granlng!Access!

Reùsing!Trial!Specific!!Queries!

Idenlfying!Potenlal!Candidates!

Contaclng!Trealng!Physicians!

Evalualng!Palents!

Managing!Recruitment!


!


4.4.1 USAGE SCENARIO: AUTHORIZING PARTICIPATION AND GRANTING ACCESS

4.4.1.1 SCENARIO PURPOSE/OBJECTIVES To!ensure!that!appropriate!authorisations!have!been!granted!for!the!participation!of!sites!in!trial!recruitment!and!for!the!release!of!EHR4CR!tools!for!use!on!local!site!EHR!data.!

4.4.1.2 SCENARIO DESCRIPTION • Sponsor!invites!sites!that!have!been!selected!to!conduct!the!trial!to!participate!in!patient!

recruitment!services.!

• Site!confirms!participation!and!gains!access!to!shared!folder!containing!patient!recruitment!query!and!other!recruitment!tools/templates!

• Site!authorises!that!local!EHR4CR!tools!can!be!run!against!locally!held!EHR!data!

• Local!Workbench!Administrator!establishes!local!rights!for!site!team!members!

4.4.2 USAGE SCENARIO: RE-USING TRIAL SPECIFIC QUERIES

4.4.2.1 SCENARIO PURPOSE/OBJECTIVES To!describe!the!development!of!detailed!patient!recruitment!queries!to!be!reùsed!at!the!site!level!to!identify!potential!patient!candidates!and!associated!Treating!Physicians.!

4.4.2.2 SCENARIO DESCRIPTION • Sponsor!creates!detailed!core!patient!recruitment!query!with!full!complement!of!

inclusion!and!exclusion!criteria!to!be!used!for!local!querying!of!EHR!data!

• Sponsor!creates!supporting!documentation!for!use!in!patient!recruitment!to!be!used!/!modified!by!site!

• System!synchronises!latest!version!of!core!patient!recruitment!query!and!documents!with!local!workbench!

• Site!can!activate/inactivate!query!statements!based!upon!richness!of!local!data!

• Site!can!set!frequency!by!which!query!is!run!

4.4.3 USAGE SCENARIO: IDENTIFYING POTENTIAL CANDIDATES

4.4.3.1 SCENARIO PURPOSE/OBJECTIVES To!query!the!local!database!to!identify!Treating!Physicians!and!patient!candidates!numbers.!

4.4.3.2 SCENARIO DESCRIPTION • Investigator/Research!Nurse!uses!local!workbench!to!run!patient!recruitment!query!

against!local!data.!

• Workbench!reports!local!Treating!Physicians!and!patient!candidate!counts!meeting!protocol!inclusion/exclusion!criteria.!

4.4.4 USAGE SCENARIO: CONTACTING TREATING PHYSICIANS

4.4.4.1 SCENARIO PURPOSE/OBJECTIVES


!


To!provide!tools!to!assist!the!Research!Physician/Investigator/Research!Nurse!in!reaching!out!to!Treating!Physicians.!

4.4.4.2 SCENARIO DESCRIPTION In!many!cases!the!Investigator!will!also!be!a!Treating!Physician!with!direct!access!to!patient!candidates.!

Where!patient!recruitment!also!requires!reaching!out!to!other!Treating!Physicians:!

• Investigator/research!coòrdinator!uses!local!workbench!to!assemble!briefing!materials!to!be!sent!to!Treating!Physicians!

• Workbench!tracks!contacts!with!Treating!Physicians!!

4.4.5 USAGE SCENARIO: EVALUATING PATIENTS

4.4.5.1 SCENARIO PURPOSE/OBJECTIVES To!describe!the!how!local!EHR4CR!tools!will!be!used!to!evaluate!patient!candidates!for!notification!and!evaluation!by!Research!Physician.!

4.4.5.2 SCENARIO DESCRIPTION • Treating!Physician!runs!recruitment!query!with!privileges!that!allow!identification!of!

individual!patients!meeting!criteria.!Report!indicates!level!of!fit!of!patient!with!inclusion/exclusion!criteria!(i.e.!how!many!criteria!cannot!be!evaluates).!!

• Patient!identifiers!are!used!by!the!Treating!Physician!to!identify!suitable!patients!for!notification!

• Report!allows!Treating!Physician!to!indicate!the!status!of!each!patient!candidate!(not!suitable,!notified,!accepted!/!denied)!

• Investigator/Research!Nurse!evaluates!notified,!accepted!patients!for!fit!with!protocol!inclusion/exclusion!criteria!and!undertakes!informed!consent!

• Local!workbench!allow!Investigator!to!record!patients!that!have!given!informed!consent!and!those!that!are!being!entered!into!the!trial!

4.4.6 USAGE SCENARIO: MANAGING RECRUITMENT

4.4.6.1 SCENARIO PURPOSE/OBJECTIVES To!provide!the!Research!Physician!with!tools!to!allow!accurate!monitoring!of!recruitment!status!for!onward!reporting!to!Sponsor!and!Ethics!Committee!when!required.!

4.4.6.2 SCENARIO DESCRIPTION • Treating!Physician!runs!summary!or!detailed!recruitment!status!report!as!required!to!

obtain!status!information!at!the!site!level!or!individual!patient!level.!

• Investigator!reports!appropriate!numbers!to!Sponsor/Ethics!Committee!as!required.!


!

26! Domain+Scenario:+Clinical+trial+Data+Exchange++ Project(Confidential(!

!

5 DOMAIN SCENARIO: CLINICAL TRIAL DATA EXCHANGE <>.!

6 DOMAIN SCENARIO: ADVERSE EVENT REPORTING <>.!


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27! Appendix+1:+Definitions/List+of+Terms++ Project(Confidential(!

!

Appendices!APPENDIX 1: DEFINITIONS/LIST OF TERMS

!

Term+ Definition+Data+Controller+ A!generic!role!responsible!for!data!protection!and!control!of!

data!ownership,!such!as!Data!Protection!Manager!or!Data!Protection!Officer!

Data+Provider+ A!generic!descriptor!to!describe!members!of!the!group!making!data!available!for!use!via!EHR4CR!services.!These!are!primarily!Healthcare!Sites!during!the!EHR4CR!project!but!may!ultimately!encompass!a!wider!range!of!sources!both!within!and!external!to!Healthcare!

Data+User+ A!collection!of!roles!that!make!use!of!data!accessible!via!EHR4CR!services.!These!roles!will!include!sponsor!roles!engaged!in!Protocol!Feasibility!or!Clinical!Trial!Data!Exchange!(such!as!Protocol!Feasibility!Manager,!Data!Manager!etc.)!as!well!as!site!roles!engaged!in!Patient!Identification!and!Recruitment,!Clinical!trial!Data!Exchange!or!population!analysis.!

EHR4CR+Services+ Any!of!the!primary!services!to!be!offered!via!the!EHR4CR!platform:!

• Protocol Feasibility • Patient Identification and Recruitment • Clinical trial Data Exchange • Adverse Event Reporting

Investigator+ The!person!responsible!for!the!conduct!of!the!clinical!trial!at!a!trial!site.!!

KPI+ Key!Performance!Indicator.!One!of!a!select!number!of!key!measures!that!enable!performance!to!be!monitored!against!targets.!The!KPI!will!indicate!how!well!the!process!or!service!attains!its!goals.!

Local+Workbench+ The!local!implementation!of!EHR4CR!tools!and!services!Local+Workbench+Administrator+ The!local!workbench!administrator!is!responsible!for!the!

local!user!and!role!management.!Patient+ A!person!receiving!or!registered!to!receive!medical!

treatment!Principal+Investigator+ If!a!trial!is!conducted!by!a!team!of!individuals!at!a!trial!site,!

the!investigator!is!the!responsible!leader!of!the!team!and!may!be!called!the!principal!investigator!

Research+Nurse+ A!member!of!the!clinical!research!team!at!the!site.!The!research!nurse!plays!a!vital!role!in!ensuring!clinical!research!studies!run!smoothly!and!that!participants!are!safe!and!fully!informed!

Sponsor+ An!individual,!company,!institution,!or!organization!which!takes!responsibility!for!the!initiation,!management,!and/or!financing!of!a!clinical!trial!

TPP+ Trusted!Third!Party.!A!trusted!third!party!is!an!individual!or!


!

28! Appendix+1:+Definitions/List+of+Terms++ Project(Confidential(!

entity!which!facilitates!interactions!between!two!parties!who!both!trust!the!third!party.!The!relying!parties!use!this!trust!to!secure!their!own!interactions!e.g.!through!certification,!monitoring,!handling!of!breaches,!repository!etc.!

Treating+Physician+ The!individual!responsible!for!the!clinical!care!of!a!patient!and!functioning!as!the!patient’s!primary!care!provider!

+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !+ !

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EHR4CR!!

Annex 2 - Patient Recruitment Software Requirements Specification v 1.0

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D1.2!Requirements!specification!and!pilot!evaluation!criteria! ! Page!39!!!

!!!!Subject!Identification!and!Recruitment!Software!Requirements!Specification!Töresin(Karakoyun,(Christian(Krauth,(Martin(Eckert,(,(Benjamin(Braasch,(Benjamin(Trinczek(

Version:(1.0(

Status:(Freezed(

05.11.2012(

( (

(

05/12/2012! EHR4CR(Consortium! Page 2 of 58

(

1. Document Information

1.1. Document description Document(Id(

Subject(Identification(and(Recruitment(–(Software(Requirements(Specification((EHR4CR(Subject(Recruitment(SRS_FREEZED.docx(

Status( FREEZED(

Document(Type(

( Security( EHR4CR(Consortium(

Revision( 1.0( Date( 05/12/2012(Title( Subject(Identification(and(Recruitment(–(Software(Requirements(Specification(Subject( (

1.2. Document history Date Revision Author Changes 20120521( 0.0( C.(Krauth(( Initial(draft(&(structure(of(document(20120523( 0.1( C.(Krauth( Phases(of(a(subject(recruitment(process(&(new(

functionalities(20120612( 0.2( C.(Krauth( content((&(mockups((20120629( 0.3( T.(Karakoyun( (

20120824( 0.8( A.(Pichowski( last(internal(revision(20120917( 0.9( M.(Eckert,(C.(Krauth( review(by:(Sebastian(John,(Benjamin(Trinczek,(Jos(

Devlies,(Andreas(Schmidt,(Andreas(Grass,(Caroline(Lafitte(

20120920( 0.1( T.(Karakoyun,(M.(Eckert(

transformed(informal(capability(description(to(software(requirement(specification(

20121001( 0.2( C.(Krauth,(M.(Eckert( created(use(case(descriptions(20121002( 0.3( M.(Eckert,(C.(Krauth( created(mockups(20121005( 0.4( T.(Karakoyun,(M.(

Eckert(overall(document(structure(

20121005( 0.5( T.(Karakoyun,(M.(Eckert,(B.(Braasch,(C.(Sideris(

data(requirements(added,(graphics(edited(

20121008( 0.6( T.(Karakoyun,(M.(Eckert,(B.(Braasch,(C.(Sideris,(C.(Krauth(

internal(working(documentation(

20121018( 0.7( C.(Krauth,(M.(Eckert(B.(Braasch,((((

Freeze(Candidate(version(after(Paris(workshop(UCbadded,(role(/(system(naming(conventions(/(sequence(diagram(changed(

20121102( 0.8( C.(Krauth,(M.(Eckert(B.(Braasch(

Finalization(of(Freeze(Candidate(

20121207( 1.0( M.(Eckert,(C.(Krauth( Refinalization(of(Freeze(Candidate(

( (

(


(

!

( (

(


(

2. Table of Contents 1.( Document(Information ................................................................................................................... 2(

1.1.( Document(description............................................................................................................. 2(

1.2.( Document(history.................................................................................................................... 2(

2.( Table(of(Contents ............................................................................................................................ 4(

3.( Software(Requirements(Specification((SRS)(Document .................................................................. 8(

3.1.( SRS(Description ....................................................................................................................... 8(

3.2.( SRS(Overview .......................................................................................................................... 8(

3.3.( Related(Documents................................................................................................................. 8(

3.3.1( Developed(Documents .................................................................................................... 8(

3.3.2( Literature/Reference(Documents ................................................................................... 9(

4.( Tools,(Methods(and(Approach ...................................................................................................... 11(

4.1.( Method(&(Approach ............................................................................................................. 11(

4.2.( Template(for(Use(Cases......................................................................................................... 11(

4.3.( Naming(Conventions ............................................................................................................. 11(

5.( General(Description(of(Subject(Identification(and(Recruitment ................................................... 13(

5.1.( Role(Descriptions .................................................................................................................. 13(

5.2.( Phases(of(Subject(Identification(and(Recruitment ................................................................ 14(

5.3.( Functional(Overview ............................................................................................................. 16(

6.( Identification(and(Recruitment(Services ....................................................................................... 17(

6.1.( Scope(of(Identification(and(recruitment(services ................................................................. 17(

6.2.( Request,(grant(or(deny(authorization ................................................................................... 18(

6.3.( Use(Case(Diagram(–(Identification(and(recruitment(services ............................................... 19(

6.4.( Use(Case(Descriptions(–(Identification(and(recruitment(services ......................................... 19(

6.4.1( Add(Participating(Sites .................................................................................................. 19(

6.4.2( Grant/Deny(Access(to(Site............................................................................................. 20(

6.4.3( Remove(sites ................................................................................................................. 20(

6.4.4( Share(study.................................................................................................................... 21(

6.4.5( Publish(Study................................................................................................................. 21(

6.4.6( Publish(Interest(to(Participating(Site............................................................................. 22(

6.4.7( Add(Link(to(Feasibility(Study ......................................................................................... 22(

( (

(


(

6.4.8( Remove(Link(to(Feasibility(Study................................................................................... 23(

6.4.9( Show(List(of(Linked(Queries .......................................................................................... 24(

6.4.10( Show(List(of(Sites........................................................................................................... 24(

6.4.11( Show(List(of(Results....................................................................................................... 25(

6.4.12( Show(List(of(Studies ...................................................................................................... 25(

6.4.13( Show(Details(of(Studies ................................................................................................. 25(

6.4.14( Site(Confirmation .......................................................................................................... 26(

6.4.15( Add(New(Query ............................................................................................................. 26(

6.4.16( Modify(Query ................................................................................................................ 27(

6.4.17( Add(Comments.............................................................................................................. 27(

6.4.18( Edit(Comments.............................................................................................................. 27(

6.4.19( Remove(Comments ....................................................................................................... 28(

6.5.( Mockups................................................................................................................................ 28(

7.( Subject(Identification .................................................................................................................... 32(

7.1.( Scope(of(Subject(Identification ............................................................................................. 32(

7.2.( Use(Case(Diagram(–(Subject(Identification ........................................................................... 33(

7.3.( Use(Case(Descriptions(–(Subject(Identification ..................................................................... 33(

7.3.1( Show(Dashboard ........................................................................................................... 33(

7.3.2( Run(Query ..................................................................................................................... 34(

7.3.3( Change(study(specific(status(of(Subject ........................................................................ 34(

7.3.4( See(Subject(List.............................................................................................................. 35(

7.3.5( See(Subject(Details ........................................................................................................ 35(

7.3.6( Notify(Treating(Physician(s)........................................................................................... 35(

7.3.7( Export(List(of(Subjects ................................................................................................... 36(

7.4.( Mockups................................................................................................................................ 37(

8.( Subject(Recruitment ..................................................................................................................... 38(

8.1.( Scope(of(Subject(Recruitment............................................................................................... 38(

8.2.( Use(Case(Diagram(–(Subject(Recruitment............................................................................. 39(

8.3.( Use(Case(Descriptions(–(Subject(Recruitment ...................................................................... 39(

8.3.1( Show(Dashboard ........................................................................................................... 39(

8.3.2( Change(study(specific(status(of(Subject ........................................................................ 39(

8.3.3( Change(additional(status(of(Subject.............................................................................. 40(

( (

(


(

8.3.4( Enter(Recruitment(Denied(Reason................................................................................ 40(

8.3.5( Export(List(of(Subjects ................................................................................................... 41(

8.4.( Mockbups .............................................................................................................................. 42(

9.( User(Management(at(Local(Workbench ....................................................................................... 43(

9.1.( Scope(of(User(Management.................................................................................................. 43(

9.2.( Use(Case(Diagram(–(User(Management................................................................................ 43(

9.3.( Use(Case(Descriptions(–(User(Management ......................................................................... 44(

9.3.1( Add(User........................................................................................................................ 44(

9.3.2( Edit(User........................................................................................................................ 44(

9.3.3( Remove(User ................................................................................................................. 44(

9.3.4( Change(Password .......................................................................................................... 45(

9.3.5( Request(for(New(Password ........................................................................................... 45(

9.3.6( Create(Role.................................................................................................................... 46(

9.3.7( Modify(Role ................................................................................................................... 46(

9.3.8( Remove(Role ................................................................................................................. 46(

9.3.9( Assign(User(to(Role........................................................................................................ 47(

9.3.10( Withdraw(User(from(Role ............................................................................................. 47(

9.3.11( Assign(Access(Rights(to(Role ......................................................................................... 47(

9.3.12( Withdraw(Access(Rights(from(Role ............................................................................... 48(

9.3.13( Assign(User(to(Study...................................................................................................... 48(

9.3.14( Withdraw(User(from(Study ........................................................................................... 48(

9.4.( Mockups................................................................................................................................ 49(

10.( Data(Requirements ................................................................................................................... 50(

10.1.( Local(workbench(development ......................................................................................... 50(

10.2.( High(Level(Information(Model .......................................................................................... 50(

10.3.( Access(Rights ..................................................................................................................... 50(

10.3.1( Study(Manager .............................................................................................................. 50(

10.3.2( Data(Relation(Manager ................................................................................................. 51(

10.3.3( Investigator ................................................................................................................... 51(

10.3.4( Treating(Physician ......................................................................................................... 51(

10.3.5( Workbench(Administrator ............................................................................................ 51(

10.4.( Clinical(Study ..................................................................................................................... 52(

( (

(


(

10.5.( Role(Based(Access(Control(for(Central(Platform ............................................................... 52(

10.6.( Role(Based(Access(Control(for(Local(Subject(Identification(and(Recruitment(Workbench53(

10.7.( States(of(a(site((study(related) .......................................................................................... 53(

10.8.( States(of(a(subject ............................................................................................................. 54(

10.8.1( Study(related(subject(states((1st(level(states)................................................................ 54(

10.8.2( Additional(subject(states((2nd(level(states) .................................................................... 54(

10.8.3( Subject(“DENIED”(Reasons............................................................................................ 55(

10.9.( Identification(and(Recruitment(Services ........................................................................... 56(

10.10.( Subject(Identification ........................................................................................................ 56(

11.( Tables(and(Figures..................................................................................................................... 58(

(

( (

(

05/12/2012! EHR4CR(Consortium! Page 8 of 58 (

3. Software Requirements Specification (SRS) Document The(purpose(of(the(document(is(to(describe(the(expected(functionalities(and(specify(the(requirements(of(the(EHR4CR(platform(for(supporting(the(subject(identification(and(recruitment(scenario.(This(document(focuses(on(the(envisaged(functionality(provided(by(EHR4CR(to(identify(

individual(subjects(that(match(a(set(of(prebdefined(criteria,(and(that(support(further(followbup(and(possible(enrolment(of(the(subject(in(clinical(studies.(

3.1. SRS Description The(objectives(of(this(specification(document(are(to(formally(specify(the(envisaged(EHR4CR(System:(

• Provide(a(system(overview(of(the(envisaged(EHR4CR(system(including(definition,(goals,(objectives,(context(and(major(capabilities(in(a(software(requirements(specification((SRS)(

• Use(cases/use(case(descriptions((functional(requirements)(

• Processes(

• Mockbups(

• Data(requirements(

3.2. SRS Overview This(specification(is(organized(into(the(following(sections:(

• Software( requirements( specification( document,( which( introduces( the( specification( for( the(EHR4CR(platform(and(Local(Workbench.(

• Tools,(methods(and(approach,(which( illustrates(the(used(tools,(methods(and(approaches( in(the(specification(for(the(EHR4CR(platform(

• Actors,( which( provides( a( brief( description( and( the( associated( responsibilities( of( the(actors/roles(

• Use(cases(that(specify(the(envisaged(usage(of(the(EHR4CR(platform(in(terms(of(a(conceptual(model(

• Processes(that(specify(the(envisaged(stepbbybstep(interaction(with(the(EHR4CR(platform(

• Data(requirements(

3.3. Related Documents

3.3.1 Developed Documents No.! Name!of!Document! Author! Date!

[1]! EHR4CR(Protocol(Feasibility(Specification(v1.0( T.(Karakoyun(et(al.( 15.12.2011(

Table!1:!Developed!Documents!

( (

(


(

3.3.2 Literature/Reference Documents No.! Document! Date!

1! Excerpt(from(""Usability(Engineering:(ScenariobBased(Development(of(

Human(Computer(Interaction""(by(Mary(Beth(Rosson,(John(M.(

Carrollhttp://ldt.stanford.edu/~gimiller/Scenariob

Based/ProblemScen.htm(

July(2011(

2! The(Open(Architecture(Group,(Copyright:(The(Open(Group,(All(Rights(

Reserved(TOGAF(is(a(trademark(of(The(Open(Group,(

http://pubs.opengroup.org/architecture/togaf8b

doc/arch/chap34.html#tag_35_01(

July(2011(

3! Agile(Software(Requirements:(Lean(Requirements(Practices(for(Teams,(

Programs,(and(the(Enterprise((Agile(Software(Development),Dean(

Leffingwell((Author),(Don(Widrig((Author),(Addison(Wesley;(1(edition((

27(December(2010(

4! Alistair(Cockburn,(http://alistair.cockburn.us/Use+case+fundamentals( (

5! Supporting(ScenariobBased(Requirements(Engineering,(Alistair(G.(

Sutcliffe,(Member,(IEEE,(Neil(A.M.(Maiden,(Member,(IEEE,Shailey(

Minocha,(and(Darrel(Manuel,(IEEE(TRANSACTIONS(ON(SOFTWARE(

ENGINEERING,(VOL.(24,(NO.(12(

December(1998(

6! Dean(Leffingwell(and(Don(Widrig,(Managing(Software(Requirements:(A(

Use(Case(Approach((2(ed.),(Pearson(Education.(

2003(

7! A.M.(Davis,(Software(Requirements:(Objects,(Functions(and(States,(

Prentice(Hall.(

1993(

8! J.(Goguen(and(C.(Linde,("Techniques(for(Requirements(Elicitation,"(

presented(at(International(Symposium(on(Requirements(Engineering.(

1993(

9! IEEE(Std(830b1998,(IEEE(Recommended(Practice(for(Software(

Requirements(Specifications,(IEEE,(1998.((IEEE14143.1b00)(IEEE(Std(

14143.1b2000//ISO/IEC14143b1:1998,(Information(Technology—

Software(Measurement—Functional(Size(Measurement—Part(1:(

Definitions(of(Concepts,(IEEE.(

2000(

10! G.(Kotonya(and(I.(Sommerville,(Requirements(Engineering:(Processes(and(

Techniques,(John(Wiley(&(Sons.(

2000(

11! P.(Loucopulos(and(V.(Karakostas,(Systems(Requirements(Engineering,(

McGrawbHill.(

1995(

12! S.L.(Pfleeger,("Software(Engineering:(Theory(and(Practice,"(second(ed.,(

Prentice(Hall,(Chap.(4.(

2001(

( (

(


(

13! S.(Robertson(and(J.(Robertson,(Mastering(the(Requirements(Process,(

AddisonbWesley.(

1999(

14! I.(Sommerville(and(P.(Sawyer,(Requirements(Engineering:(A(Good(

Practice(Guide,(John(Wiley(&(Sons,(Chap.(1b2.(

1997(

15! I.(Sommerville,(Software(Engineering,(seventh(ed.,(AddisonbWesley.( 2005(

16! R.H.(Thayer(and(M.(Dorfman,(eds.,(Software(Requirements(Engineering,(IEEE(Computer(Society(Press,(pp.(176b205,(389b404.(

1997(

17! R.R.(You,(Effective(Requirements(Practices,(AddisonbWesley.( 2001(

18! Cuggia(M,(Besana(P,(Glasspool(D,(Comparing(semibautomatic(systems(for(recruitment(of(patients(to(clinical(trials.(

2011(

Table!2:!Literature/Reference!Documents!

( (

(


(

4. Tools, Methods and Approach This(section(specifies(and(illustrates(the(used(tools,(methods(and(requirement(engineering(approach.((

4.1. Method & Approach This(document(is(part(of(a(use(case(driven(approach(in(software(requirements(engineering.(The(core(issue(in(doing(a(use(case(driven(approach(was(to(create(a(practically(oriented(and(lighter(document(with(lower(redundancy.(The(document(aims(to(be(sufficiently(detailed(for(a(developer(but(at(the(same(time(easy(to(read(for(a(user(with(a(lesser(technical(background.((The(following(order(of(priorities(is(used(in(the(use(cases:(

• ESSENTIAL:(Means(that(the(definition(is(an(absolute(requirement(of(the(specification.(

• EXPECTED:(Means(that(there(may(exists(valid(reasons(in(particular(circumstances(to(ignore(a(particular(item,(but(the(full(implications(must(be(understood,(carefully(weighed(and(documented(before(choosing(a(different(course.(

• OPTIONAL:(Desired((nicebtobhave)(functionality,(but(full(implications(should(be(understood(and(the(case(carefully(weighed(before(implementing(any(behaviour(described(with(this(label.(

The(general(method(and(approach(that(has(been(used(is(described(in(the(protocol(feasibility(

requirements(specification.([1](((

4.2. Template for Use Cases Use(Case(ID! "UC_"!+!FunctionalAreaAbbreviation.NameAbbreviation!+!"_"!+!Number!Summary! ((Related!UML!Diagrams! (Priority! Essential(|(Expected(|(Optional(Use!Frequency! Always(|(Often(|(Sometimes(|(Rarely(|(Once(Direct!Actors! (Prereq./Trigger! (Main!Success!Use!Case!Scenario!

(

Alternative!Use!Case!Scenario!Extensions!

(

Notes!and!Questions! (Table!3:!Template!for!Use!Cases!

4.3. Naming Conventions The following naming convention is used in the SRS:

Element! Construction! Example:!Manage!Protocols!X!(Add!New!Protocol)!

Use Case ID "UC_" + FunctionalAreaAbbreviation.NameAbbreviation + "_" + Number

UC_ManProt.AddNew_01

UML Use Case Diagram ID

"UML_UC_" + FunctionalAreaAbbreviation.NameAbbreviation + "_" + Number

UML_UC_ManProt.AddNew_01

( (

(


(

UML Use Case Diagram Name

self-explanatory name

Add New Protocol

UML Sequence Diagram Name


Add New Protocol

UML Activity Diagram Name


Add New Protocol

Table!4:!Naming!Conventions!

(

( (

(


(

5. General Description of Subject Identification and Recruitment

The(subject(identification(and(recruitment(process(can(be(started(after(a(successfully(completed(

protocol(feasibility(study(has(been(conducted.(This(means(that(based(on(the(eligibility(criteria(there(are(a(potential(number(of(subjects(in(one(or(more(specific(sites.(The(number(is(different(from(the(feasibility(numbers(because(of(the(prospective(approach(of(the(recruitment(procedure.(The(eligibility(

criteria(as(defined(in(the(protocol,(the(corresponding(query(that(has(been(used(for(the(feasibility(study(and(the(protocol(itself(are(the(main(instruments(for(the(subject(recruitment(scenario.(

In(this(scenario,(users((Study(Manager)(are(initiating(the(process(of(subject(identification(and(

recruitment(on(the(EHR4CR(platform(with(the(purpose(to(engage(Investigators(at(local(sites((hospitals)(with(access(to(a(defined(subject(population(to(recruit(subjects(that(are(candidates(for(participation(in(a(planned(clinical(research(study.(

5.1. Role Descriptions Depending(on(the(kind(of(study((Investigator(Initiated(Studies((IIT),(Investigator(Sponsored(Study((IST))(one(person(can(hold(more(than(one(role.(For(example(the(Investigator(can(be(also(the(Treating(Physician(on(a(smaller(site.(It(is(likely(that(he(also(inhabits(the(role(of(a(Data(Relation(Manager(on(a(

smaller(site.(It’s(foreseen(that(the(roles(can(be(adjusted(by(the(Local(Workbench(Manager(to(the(specific(site.(If(the(site(might(work(with(SubbInvestigators(a(fitting(role(can(be(created.((

Actor((Roles)! Description/(Responsibilities! Location!

Study(Manager! The(Study(Manager,(e.g.(a(member(of(EFPIA(or(a(CRO,(has(to( plan,( implement( and( supervise( clinical( studies( and( is(responsible( for(execution(of(a(clinical(study(while(ensuring(that( all( study( deliverables( are( met( (milestones,( budgets,(resources…).(

EHR4CR(b(Platform(

Data(Relation(Manager! The(person(responsible(for(the(management(of(the(local(site;(has(access(to(site(reports(and(can(grant(and(deny(access((to(local(site’s(data(warehouse(to(interested(party((EFPIA,(CRO)(

EHR4CR(b(Platform(

Treating(Physician! The(Treating(Physician(is(any(doctor(of(medicine(who(has(direct(contact(to(a(patient(or(a(group(of(patients.(Its(task(is(to(help(the(Investigator(in(finding(eligible(patients.(The(patient’s(request(for(participation(is(initiated(via(the(subject’s(authorised(Treating(Physicians.(

Local(Workbench(

Investigator! The(responsible(local(healthcare(professional,(who(conducts(one(or(more(studies(at(a(site(and(is(involved(in(subject(identification,(recruitment(and(study(execution(and(is(responsible(for(the(subject’s((candidate’s)(consensus.(

Local(Workbench(

( (

(


(

Local(Workbench(

Administrator!

The(Local(Workbench(Administrator((subject(identification(and(recruitment(workbench)(is(responsible(for(the(local(user(and(role(management.((

Local(Workbench(

Table!5:!New!Actor!Descriptions!

5.2. Phases of Subject Identification and Recruitment As(a(first(step(the(Study(Manager(publishes(the(study(and(shows(his(interest(in(the(relevant(sites.((

The(relevant(sites(have(been(identified(in(the(study(feasibility(step.((

When(the(Data(Relation(Manager(from(a(specific(site(logs(on(the(central(EHR4CR(platform(he(gets(an(

overview(of(potential(studies(that(can(be(run(on(his(site.((

The(Data(Relation(Manager,(after(agreement(with(his(site,(can(decide(if(his(site(takes(part(in(the(

study(or(not.(After(all(documents(and(contracts(have(been(signed(outside(of(EHR4CR(the(Study(

Manager(sets(the(status(READY(TO(GO(and(at(the(same(time(the(identification(and(recruitment(

starts.((

Additional(information(is(pulled(from(the(central(EHR4CR(Platform(to(the(local(site.((

On(the(site(the(Investigator(runs(the(query(adjusted(to(his(site(and(hands(a(list(of(potential(

candidates(to(the(Treating(Physician.((

The(Treating(Physician(now(receives(this(list(and(starts(to(check(the(patients(if(they(still(match(the(

query.(If(so(he(marks(the(subjects(as(a(candidate(and(informs(them(about(the(study.((

A(list(with(notified(and(denied(subjects(is(reported(back(to(the(Investigator(and(the(numbers(are(

reported(back(to(the(central(EHR4CR(platform(to(be(evaluated(by(the(Study(Manager.(

The(Subject(signs(the(Informed(Consent(after(the(Investigator(informed(him(about(the(study(and/or(

signs(him(up(for(a(screening.(The(included,(screening(and(denied(subject(numbers(are(reported(back(

to(the(Study(Manager.(

The(Investigator(uses(the(Local(Workbench(after(the(screening(to(report(if(the(screening(was(

successful(and(the(patient(was(included(or(if(the(screening(failed.(Also(this(numbers(are(reported(

back(to(the(central(EHR4CR(platform.(

Alternative*1*

The(subject(gets(notified(about(the(study(from(the(Investigator(and(denies(signing(the(Informed(

Consent.(In(this(case,(the(Study(Manager(gets(a(message(that(a(subject(denied(to(join(the(study.(The(

numbers(of(subjects(who(are(not(willing(to(participate(are(reported(back(to(the(Study(Manager.(The(

reported(information(is(just(a(number(and(does(not(allow(the(identification(of(a(single(patient.(

Alternative*2*

The(subject(gets(notified(about(the(study(from(the(Investigator,(signs(the(Informed(Consent(but(

needs(a(screening(phase((e.g.(washoutbphase)(to(join(the(study.(In(this(case(the(Investigator(starts(

the(screening(with(the(subject(and(if(the(screening(takes(a(positive(course(the(subject(gets(included.(

( (

(


(

The(number(of(screened(subjects(is(reported(back(to(the(Study(Manager.(The(reported(information(is(

just(a(number(and(does(not(allow(the(identification(of(a(single(patient.(

Alternative*3*

The(subject(gets(notified(about(the(study(from(the(Investigator,(signs(the(Informed(Consent(but(needs(a(screening(phase((e.g.(washoutbphase)(to(join(the(study.(In(this(case(the(Investigator(starts(the(screening(with(the(subject,(but(the(screening(fails.(At(this(juncture(the(Study(Manager(gets(an(

update(on(the(number(of(patients(where(the(screening(failed.(The(reported(information(is(just(a(number(and(does(not(allow(the(identification(of(a(single(patient.(

The(figure(below(shows(the(described(scenarios(visualized(in(a(sequence(diagram.(

(

Figure!1:!Sequence!diagram!of!Subject!Identification!and!Recruitment!

( (

(

05/12/2012! EHR4CR(Consortium! Page 16 of 58 (

5.3. Functional Overview The(EHR4CR(central(platform(shall(support(the(feasibility,(exploration,(design(and(execution(of(clinical(studies(and(longbterm(surveillance(of(subject(populations.(The(envisaged(extension(to(the(EHR4CR(platform(shall(support(the(identification(and(recruitment(process(for(relevant(subjects(and(initiate(confidential(participation(requests(via(the(subject’s(authorised(Treating(Physicians.

(

Figure!2:!new!functional!overview!of!EHR4CR!platform!interacting!with!EHR4CR!local!workbench!(Stickman!Source:!http://openclipart.org/)!

The(subject(identification(&(recruitment(workbench(will(enable(and(support(Investigators(to(identify(

potential(subjects(in(its(local(data(warehouse(and(screen(out(those(who(do(not(match(as(well(as(supporting(the(Treating(Physicians(during(the(recruitment(phase.(

((

( (

(


(

6. Identification and Recruitment Services In(the(Identification(and(Recruitment(Services(section(the(user(at(the(EHR4CR(central(platform(has(

access(to(the(list(of(their(own(clinical(studies(with(different(state((e.g.(running,(in(preparation,(

cancelled),(linked(protocol(information,(protocol(feasibility(studies(and(corresponding(queries.(The(

Identification(and(recruitment(services(section(of(central(platform(is(the(starting(point(for(initiating(of(

subject(identification(and(recruitment(process.(

On(an(additional(way(the(sponsor(of(a(clinical(study(might(be(interested(to(draw(the(attention(of(a(

Data(Relation(Manager(to(clinical(studies(on(the(platform(and(to(find(sites(that(are(interested(to(

participate(in(a(clinical(study.(

One(reason(for(the(increased(attention(on(a(clinical(study(might(be(that(the(eligibility(criteria(which(

are(supposed(to(find(subjects(with(a(specific(pathology(cannot(be(transformed(into(an(adequate(CRF.(

The(Data(Relation(Manager,(after(agreement(with(his(site,(can(grant(or(deny(authorisation(to(

participate(in(a(clinical(study(to(the(Study(Manager(to(the(interested(party(such(as(EFPIA(or(a(CRO.(

6.1. Scope of Identification and recruitment services There(is(no(envisaged(functionality/tool(for(medication(management,(site(management(or(study(

management(etc.(

As(a(Study(Manager(I(want(to:(

Be(able(to(support(investigational(sites(by(prebpopulating(queries(and(templates(with(study(

specific(information(for(sites(selected(and(preparing(for(subject(recruitment.(

Add(and(promote(clinical(studies(information(on(the(central(platform(

Publish(protocol(specific(information(

Share(study(specific(information((prebpopulating(queries(and(templates,(protocol(specific(

information)(with(sites(and(hospitals(

Request(authorisation(from(sites(to(start(identification(and(recruitment(

Rebuse(stored(queries(from(protocol(feasibility(

Create(and(modify((reused)(queries(in(order(to(meet(eligibility(criteria(

As(a(Data(Relation(Manager(I(want(to:(

Access(to(site(specific(reports(regarding(launched(queries(and(results(at(local(site,(running(

studies(and(recruited(subjects(for(a(specific(study(

Grant(or(deny(authorisation(for(a(specific(study(to(be(submitted(to(local(site(

As(an(Investigator(I(want(to:(

Access(clinical(studies(specific(information,(protocol(specific(information(and(provided(

queries(

( (

(


(

6.2. Request, grant or deny authorization The(authorization(request(is(the(process(of(obtaining(permission(from(any(local(site(to(accept(the(

clinical(study,(related(protocol(information(and(queries(to(be(submitted(to(the(local(site’s(system.(The(authorization(involves(the(assessment(of(the(Data(Relation(Manager.(The(Data(Relation(Manager,(after(agreement(with(his(site,(grants(or(denies(the(authorisation(for(a(specific(study.(A(

positive(authorization(response,(done(on(the(EHR4CR(platform,(indicates(that(study(and(protocol(specific(information(and(corresponding(queries(are(available(in(the(local(workbench(of(the(specific(site.(The(authorisation(process(secures(that(e.g.(contracts(and(study(specific(documents(are(in(place(

and(the(site(has(been(initiated.(

( (

(


(

6.3. Use Case Diagram – Identification and recruitment services

(

Figure!3:!Use!Case!Diagram!X!Identification!and!recruitment!services!

6.4. Use Case Descriptions – Identification and recruitment services

6.4.1 Add Participating Sites Use!Case!ID! UC_IdentificationRecruitmentServices.AddSites_01!

( (

(


(

Summary! The(Study(Manager(is(able(to(add(one(or(more(participating(sites(to(a(study.((Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Essential(Use!Frequency! Always(Direct!Actors! Study(Manager(Prereq./Trigger! At(least(one(study(and(one(site(are(available.(

User(has(access(right(to(add(sites.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(identification(and(recruitment(services.(2. User(browses(through(list(of(available(studies,(depending(on(access(

rights.((Studies(are(listed(by(study(ID,(EudraCT1(number,(sponsor(name,(site(name,(dept.,(unit,(town,(creation(date,(modification(date(and(status.(

3. User(selects(study.(4. User(browses(through(list(of(sites,(depending(on(access(rights.(Sites(

are(listed(by(name,(date,(last(editor,(etc.(5. User(selects(one(or(more(sites(to(be(added(to(the(study.(6. User(accepts(changes((7. Study(is(saved(by(the(system.(


(

Notes!and!Questions! An(entry(in(the(audit(trail(of(the(study(is(created.(! (

6.4.2 Grant/Deny Access to Site Use!Case!ID! UC_IdentificationRecruitmentServices.GrantDenyAccessToSites_01!Summary! The(Data(Relation(Manager(is(able(to(grant(or(deny(the(access(to(his(site(for(a(

study((Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Essential(Use!Frequency! Always(Direct!Actors! Data(Relation(Manager(Prereq./Trigger! At(least(one(study(and(one(site(are(available.(

User(has(access(right(to(grant/deny(access(to(site.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(identification(and(recruitment(services.(2. User(browses(through(list(of(available(studies(for(his(site.((

Studies(are(listed(by(study(ID,(EudraCT(number,(sponsor(name,(creation(date,(modification(date(and(status.(

3. User(selects(study(s).(4. User(browses(through(list(of(studies,(depending(on(access(rights.(

Studies(are(listed(by(name,(date,(last(editor,(etc.(5. User(grants(access(to(his(site.(


5.((User(denies(access(to(his(site.(

Notes!and!Questions! An(entry(in(the(audit(trail(of(the(study(is(created.(! (

6.4.3 Remove sites Use(Case(ID! UC_IdentificationRecruitmentServices.RemoveSites_01!

(((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((1(https://eudract.ema.europa.eu/(

( (

(


(

Summary! The(Study(Manager(is(able(to(remove(one(or(more(sites(from(a(study.((Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Essential(Use!Frequency! Sometimes(Direct!Actors! Study(Manager(Prereq./Trigger! At(least(one(study(with(one(site(is(available.(

User(has(access(right(to(remove(sites.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(identification(and(recruitment(services.(User(browses(through(list(of(available(studies,(depending(on(access(rights.(Studies(are(listed(by(study(ID,(EudraCT(number,(sponsor(name,(site(name,(dept.,(unit,(town,(creation(date,(modification(date(and(status.(

2. User(selects(study.(3. User(browses(through(list(of(sites,(depending(on(access(rights.(Sites(

are(listed(by(name,(date,(last(editor,(etc.(4. User(selects(one(or(more(sites(to(be(removed(from(the(study.(

5. User(accepts(changes((6. Site((e.g.(Data(Relation(Manager)(gets(notified(by(the(system(by(mail(

7. Study(is(saved(by(the(system.(Alternative!Use!Case!Scenario!Extensions!

(

Notes!and!Questions! An(entry(in(the(audit(trail(of(study(is(created.(

6.4.4 Share study Use(Case(ID! UC_IdentificationRecruitmentServices.ShareStudy_01!Summary! The(Study(Manager(is(able(to(share(a(study(to(other(organisations((e.g.(CRO).((Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Essential(Use!Frequency! Sometimes(Direct!Actors! Study(Manager(Prereq./Trigger! At(least(one(study(is(available.(

User(has(access(right(to(share(studies.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(identification(and(recruitment(services.(User(browses(through(list(of(available(studies,(depending(on(access(rights.((Studies(are(listed(by(study(ID,(EudraCT(number,(sponsor(name,(site(name,(dept.,(unit,(town,(creation(date,(modification(date(and(status.(

2. User(selects(study.(3. User(assigns(other(organization(to(the(study.(4. For(each(organization(access(rights(are(defined.((5. User(saves(study.(


Email(is(sent(to(assigned(organisation(by(the(system.(


6.4.5 Publish Study Use(Case(ID! UC_IdentificationRecruitmentServices.PublishStudy_01!Summary! The(Study(Manager(is(able(to(publish(one(or(more(studies(to(the(platform((Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Essential(

( (

(


(

Use!Frequency! Always(Direct!Actors! Study(Manager(Prereq./Trigger! At(least(one(study(is(available.(

User(has(access(right(to(publish(sites.(Study(status(is(neither(FINISHED(or(CANCELLED(or(ANALYSIS(

Main!Success!Use!Case!Scenario!

1. User(navigates(to(identification(and(recruitment(services.(

User(browses(through(list(of(available(studies,(depending(on(access(rights.((Studies(are(listed(by(study(ID,(EudraCT(number,(sponsor(name,(site(name,(dept.,(unit,(town,(creation(date,(modification(date(and(status.(

2. User(selects(study.(

3. User(publishes(the(study.(

4. Study(is(published(to(platform(and(user(gets(a(confirmation(for(

positive(publishing(of(the(study.(


(

Notes!and!Questions! An(entry(in(the(audit(trail(that(the(study(is(published.(

6.4.6 Publish Interest to Participating Site Use(Case(ID! UC_IdentificationRecruitmentServices.PublishInterest_01!Summary! The(Study(Manager(is(able(to(directly(communicate(his(interest(to(a(specific(

site.((Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Essential(Use!Frequency! Sometimes(Direct!Actors! Study(Manager(Prereq./Trigger! At(least(one(study(with(one(site(is(available.(

User(has(access(right(to(contact(sites.(Main!Success!Use!Case!Scenario!


2. User(browses(through(list(of(available(studies,(depending(on(access(

rights.(Studies(are(listed(by(study(ID,(EudraCT(number,(sponsor(name,(

site(name,(dept.,(unit,(town,(creation(date,(modification(date(and(

status.(


4. User(browses(through(list(of(sites,(depending(on(access(rights.(Sites(

are(listed(by(name,(date,(last(editor,(etc.(

5. User(selects(one(or(more(sites(to(be(contacted(directly.(

6. User(message(is(generated(by(system(and(is(customizable(by(the(user(

7. System(sends(a(message(to(all(selected(sites.(

8. User(gets(a(confirmation(when(message(has(been(seen(by(site.(


7.((System(cannot(send(message(to(at(least(one(site(or(retrieves(at(least(one(error(message.(User(gets(confirmation(about(number(of(failed(messages.(

Notes!and!Questions! An(entry(in(the(audit(trail(of(study(is(created.(Is(it(needed(to(send(customized(messages(to(the(site(or(is(a(standard(message(legit?(

6.4.7 Add Link to Feasibility Study Use(Case(ID! UC_IdentificationRecruitmentServices.AddLink_01!Summary! The(Study(Manager(is(able(to(create(a(link(to(the(Feasibility(Study(

( (

(


(

Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Essential(Use!Frequency! Sometimes(Direct!Actors! Study(Manager(Prereq./Trigger! At(least(one(study(and(one(feasibility(study(is(available.(

User(has(access(right(to(link(studies(to(feasibility(studies.(Main!Success!Use!Case!Scenario!


rights.(Studies(are(listed(by(study(ID,(EudraCT(number,(sponsor(name,(site(name,(dept.,(unit,(town,(creation(date,(modification(date(and(

status.(3. User(selects(study.(

4. User(browses(through(list(of(available(feasibility(studies,(depending(on(access(rights.(Studies(are(listed(by(study(ID,(EudraCT(number,(sponsor(

name,(site(name,(dept.,(unit,(town,(creation(date,(modification(date(and(status.(

5. User(selects(one(or(more(studies.(6. User(adds(link(to(feasibility(study.(


(


6.4.8 Remove Link to Feasibility Study Use(Case(ID! UC_IdentificationRecruitmentServices.RemoveLink_01!Summary! The(Study(Manager(is(able(to(remove(a(link(to(feasibility(study(Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Essential(Use!Frequency! Sometimes(Direct!Actors! Study(Manager(Prereq./Trigger! At(least(one(study(with(one(linked(feasibility(study(is(available.(

User(has(access(right(to(remove(links(between(studies(and(feasibility(studies.(Main!Success!Use!Case!Scenario!




4. Already(added(feasibility(studies(are(preselected(in(list(of(available(feasibility(studies,(depending(on(access(rights.(Studies(are(listed(by(

study(ID,(EudraCT(number,(sponsor(name,(site(name,(dept.,(unit,(town,(creation(date,(modification(date(and(status.(

5. User(selects(one(or(more(added(studies.(6. User(removes(link(to(feasibility(study.(


(

Notes!and!Questions! An(entry(in(the(audit(trail(of(study(is(created.(Maybe(just(one(button(for(add/(remove(links((set/(unset(link)?(

( (

(


(

6.4.9 Show List of Linked Queries Use(Case(ID! UC_IdentificationRecruitmentServices.ShowQueryList_01!Summary! The(user(is(able(to(see(a(list(of(linked(queries(

Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(

Priority! Essential(

Use!Frequency! Always(

Direct!Actors! Study(Manager(

Prereq./Trigger! At(least(one(study(with(at(least(one(linked(query(is(available.(






status.(


4. Linked(queries(are(shown.(


(


6.4.10 Show List of Sites Use(Case(ID! UC_IdentificationRecruitmentServices.ShowSiteList_01!Summary! The(Study(Manager(is(able(to(see(a(list(of(available(/(participating(sites((

Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(

Priority! Essential(

Use!Frequency! Always(

Direct!Actors! Study(Manager(

Prereq./Trigger! At(least(one(study(and(one(site(are(available.(

User(has(access(right(to(see(sites.(






status.(


4. User(browses(through(list(of(available(/(participating(sites,(depending(

on(access(rights.(Sites(are(listed(by(name,(query(results((if(available(

and(linked(to(protocol(feasibility(study)(and(status:((

a. PARTICIPATING(

b. AVAILABLE(

c. PENDING_AUTHORIZATION(

5. User(requests(site(details:(

• Name(

• Contact(person(

• Contact(address((region)(

• Country(

(


(

Notes!and!Questions! (

( (

(


(

6.4.11 Show List of Results Use(Case(ID! UC_IdentificationRecruitmentServices.ShowListofResults_01!Summary! The(Study(Manager(is(able(see(a(List(of(Results((Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Essential(Use!Frequency! Always(Direct!Actors! Study(Manager(Prereq./Trigger! At(least(one(study(is(available.(

User(has(access(right(to(see(query(results.(Main!Success!Use!Case!Scenario!




4. Linked(queries(are(shown(with(query(results(as(in(Feasibility(Study((see([1]).(

5. User(selects(a(query(and(requests(further(details.(6. Query(results(are(shown.(


(


6.4.12 Show List of Studies Use(Case(ID! UC_IdentificationRecruitmentServices.ShowListofStudies_01!Summary! The(user((is(able(see(a(list(of(Studies((Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Essential(Use!Frequency! Always(Direct!Actors! Study(Manager,(Data(Relation(Manager(Prereq./Trigger! At(least(one(study(is(available.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(identification(and(recruitment(services(2. A(list(of(studies(is(displayed.(According(to(his(role(/(access(rights(the(

user(can(sort(and(filter(the(studies(by(status(e.g.(PLANNING,(EXECUTING,(ANALYSIS,(FINISHED,(CANCELLED.(Also(published(studies(

are(indicated.(Alternative!Use!Case!Scenario!Extensions!

(

Notes!and!Questions! This(is(part(of(the(same(interface(as(UC(Show(List(of(Results(An(entry(in(the(audit(trail(of(study(is(created?(

6.4.13 Show Details of Studies Use(Case(ID! UC_IdentificationRecruitmentServices.ShowDetailsofStudy_01!Summary! The(user((is(able(see(details(of(the(Study((Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Essential(Use!Frequency! Always(Direct!Actors! Study(Manager,(Data(Relation(Manager(Prereq./Trigger! At(least(one(study(is(available.(

( (

(


(

User(has(access(right(to(see(study(details.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(identification(and(recruitment(services((



creation(date,(modification(date(and(status.(

3. User(selects(study(and(requested(further(details.(

4. Details(of(study((Sponsor(Information,(Contact(Details,(Feasibility(

Query,(Status(of(Study,(EudraCT(number)(are(displayed.(


(


6.4.14 Site Confirmation Use(Case(ID! UC_IdentificationRecruitmentServices.SiteConfirmation_01!Summary! The(user((is(able(to(report(back(the(status(of(his(site(Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Essential(Use!Frequency! Always(Direct!Actors! Data(Relation(Manager(Prereq./Trigger! At(least(one(study(with(the(user’s(site(is(available.(

User(has(access(right(to(contact(sites.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(identification(and(recruitment(services((



creation(date,(modification(date(and(status.(

3. User(selects(study(and(sets(status(to(“READY(TO(GO”(

4. Status(is(reported(back(to(Study(Manager(


(

Notes!and!Questions! The(“READY(TO(GO”(Status(is(set(after(all(Documents(were(signed(and(sent(back(to(the(Study(Manager((outside(of(EHR4CR)(

6.4.15 Add New Query Use(Case(ID! UC_IdentificationRecruitmentServices.AddNewQuery_01!Summary! The(Study(Manager(is(able(to(create(a(new(query(for(patient(identification(and(

recruitment((see[1])(Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Expected(Use!Frequency! Sometimes(Direct!Actors! Study(Manager(Prereq./Trigger! User(has(access(rights(to(add(queries.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(Identification(and(Recruitment(Services.(2. User(selects(Query(Manipulation(3. User(is(redirected(to(Query(Workbench(as(implemented(in(Protocol(

Feasibility(4. Query(is(linked(to(the(related(study(as(identification(and(recruitment(

query(Alternative!Use!Case!Scenario!Extensions!

(

( (

(


(

Notes!and!Questions! An(entry(in(the(audit(trail(is(created(

6.4.16 Modify Query Use(Case(ID! UC_IdentificationRecruitmentServices.ModifyQuery_01!Summary! The(Study(Manager(is(able(to(modify(or(reuse(the(query(that(was(created(for(

the(protocol(feasibility(study((see([1])(Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Desired(Use!Frequency! Sometimes(Direct!Actors! Study(Manager(Prereq./Trigger! User(has(access(rights(to(modify(queries.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(Identification(and(Recruitment(Services.(2. User(selects(Query(Manipulation(3. User(is(redirected(to(Query(Workbench(as(implemented(in(Protocol(

Feasibility(4. Query(is(linked(to(the(related(study(as(identification(and(recruitment(

query(Alternative!Use!Case!Scenario!Extensions!

(

Notes!and!Questions! A(new(version(of(the(query(is(created(and(an(entry(in(the(audit(trail(is(created(

6.4.17 Add Comments Use(Case(ID! UC_IdentificationRecruitmentServices.AddComments_01!Summary! The(Study(Manager(is(able(to(add(comments(to(a(protocol.(Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Desired(Use!Frequency! Sometimes(Direct!Actors! Study(Manager(Prereq./Trigger! At(least(one(study(with(a(protocol(is(available.(

User(has(access(rights(to(edit(protocol.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(Identification(and(Recruitment(Services.(2. User(browses(through(list(of(available(studies,(depending(on(access(

rights.(Studies(are(listed(by(study(ID,(EudraCT(number,(sponsor(name,(creation(date,(modification(date(and(status.(

3. User(selects(study.(4. User(selects(the(protocol.(5. User(adds(comment(to(protocol.(6. User(accepts(changes.(7. Protocol(is(saved(by(the(system(as(a(new(version.(


(

Notes!and!Questions! An(entry(in(the(audit(trail(is(created.(

6.4.18 Edit Comments Use(Case(ID! UC_IdentificationRecruitmentServices.EditComments_01!Summary! The(Study(Manager(is(able(to(edit(the(comments(of(a(protocol.(Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Desired(Use!Frequency! Sometimes(Direct!Actors! Study(Manager(Prereq./Trigger! At(least(one(study(with(one(protocol(and(comment(is(available.(

( (

(


(




3. User(selects(study.(4. User(selects(protocol.(5. User(selects(comment(to(be(edited.(6. User(changes(comment.(7. User(accepts(changes.(8. Protocol(is(saved(by(the(system(as(a(new(version.(


(


6.4.19 Remove Comments Use(Case(ID! UC_IdentificationRecruitmentServices.RemoveComments_01!Summary! The(Study(Manager(is(able(to(remove(comments.(Related!UML!Diagrams! Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services(Priority! Desired(Use!Frequency! Sometimes(Direct!Actors! Study(Manager(Prereq./Trigger! At(least(one(study(with(one(protocol(and(comment(is(available.(




3. User(selects(study.(4. User(selects(protocol.(5. User(selects(comment(to(be(removed(from(protocol.(6. User(accepts(changes.(7. Protocol(is(saved(by(the(system(as(a(new(version.(


(


(

6.5. Mockups (

Figure!4:!MockXup!X!Study!Dashboard!(Data!Relation!Manager)!

( (

(


(

!

Figure!5:!MockXup!X!Study!Dashboard!(Study!Manager)!

(

( (

(


(

(

Figure!6:!MockXup!X!Link!to!feasibility!results!

( (

(


(

(

Figure!7:!MockXup!X!Show!Queries!

( (

(


(

7. Subject Identification The(Subject(Identification(step(takes(place(on(the(local(workbench.(

7.1. Scope of Subject Identification In(the(subject(identification(process,(the(Investigator(has(the(possibility(to(select(an(available(study(

for(its(site(and(can(see(the(eligibility(criteria(and(the(corresponding(query(for(this(study.(After(checking(the(query(the(Investigator(can(execute(the(query.(The(result(will(be(an(internal(list(of(all(candidate(subjects(found(in(the(electronic(health(records.((

The(Investigator(is(able(to(see(how(many(potentially(eligible(subjects(are(found(per(

clinic/department/organization(unit(within(its(own(site.(The(Investigator(can(select(which(clinics(and(associated(Treating(Physicians(shall(be(contacted(via(the(system.(After(contacting,(each(Treating(Physician(is(able(to(see(identified(subjects(that(might(be(eligible(for(the(study((e.g.(“candidate(list”).((

Based(on(this,(each(Treating(Physician(is(able(to(contact(each(of(its(potentially(eligible(subjects,(

explain(the(basics(of(the(study(and(ask(for(permission(that(the(Investigator(gains(access(to(the(subjects’(patient(data(for(contacting.(The(Treating(Physician(tags(every(willing(subject(as(“notified”,(making(the(Investigator(able(to(see(patient(details(of(these(subjects(and(move(on(to(Patient(

Recruitment.(

(

( (

(


(

7.2. Use Case Diagram – Subject Identification

(

Figure!8:!Use!Case!Diagram!X!Subject!Identification!

7.3. Use Case Descriptions – Subject Identification

7.3.1 Show Dashboard Use(Case(ID! UC_SubjectIdentification.ShowDashboard_01!Summary! User(is(able(see(list(of(subjects(and(identification(status(on(Dashboard(Related!UML!Diagrams! Figure(8:(Use(Case(Diagram(b(Subject(Identification(Priority! Expected(Use!Frequency! Always(Direct!Actors! Treating(Physician(Prereq./Trigger! At(least(one(study(with(one(subject(is(available.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(subject(identification((dashboard).(2. User(browses(through(list(of(available(studies.(Numbers(of(potential,(

screened(and(recruited(subjects(are(listed((update(since(last(login)(Alternative!Use!Case!Scenario!Extensions!

(

Notes!and!Questions! Last(changes(in(the(identification(procedure(are(shown(in(dashboard.(

( (

(


(

7.3.2 Run Query Use(Case(ID! UC_SubjectIdentification.RunQuery_01!Summary! User(is(able(to(run(a(query.(Related!UML!Diagrams! Figure(8:(Use(Case(Diagram(b(Subject(Identification(Priority! Essential(Use!Frequency! Always(Direct!Actors! Investigator(Prereq./Trigger! At(least(one(query(is(available.(

User(has(access(right(to(run(a(query.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(subject(identification.(2. User(browses(through(list(of(available(queries,(depending(on(access(

rights.(Queries(are(listed(by(study(title,(creation(date,(modification(date,(last(editor(or(status.(

3. User(selects(query.(4. User(runs(query.((5. System(displays(results.(


(

Notes!and!Questions! Query(runs(automatically(every(24h(and(user(receives(an(email(when(subject(count(changed.(An(entry(in(the(audit(trail(is(created.(

7.3.3 Change study specific status of Subject Use(Case(ID! UC_SubjectIdentification.ChangeStudySpecificStatusOfSubject_01!Summary! User(is(able(to(change(the(status(of(a(subject.(Related!UML!Diagrams! Figure(8:(Use(Case(Diagram(b(Subject(Identification(Priority! Essential(Use!Frequency! Always(Direct!Actors! Treating(Physician(Prereq./Trigger! At(least(one(study(with(one(identified(and(not(denied(subject(is(available.(

User(has(access(right(to(change(status(of(subject.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(subject(identification.(2. User(browses(through(list(of(available(studies,(depending(on(access(

rights.(Studies(are(listed(by(ID,(sponsor,(title(or(last(update.(3. User(selects(study.(4. System(lists(and(user(browses(through(potentially(eligible(subjects.(

Subjects(are(listed(by(ID,(name,(birthday(or(date(of(identification.(5. User(informs(subject(about(study((not(in(local(workbench).(6. User(changes(1st(level(status(of(subject(to(“NOTIFIED”.(7. User(confirms(status(change.(


a)(6. Subject(does(not(fit(to(study.(User(changes(1st(level(status(to(

“DENIED”.(7. User(documents(reason(for(denial.(8. User(confirms(status(change.(

b)(6. Subject(fits(into(study((based(on(queried(eligibility(criteria(and(

Treating(Physician’s(opinion)(but(doesn’t(want(to(participate(in(this/any(study.(User(changes(1st(level(status(to(“DENIED”.(

7. User(documents(reason(of(denial(from(a(list.(8. User(confirms(status(change.(


( (

(


(

Status(changes(need(to(be(time(stamped(Counts(of(denied(b(reasons(are(going(to(be(reported(back(to(central(EHR4CR(Platform(

7.3.4 See Subject List Use(Case(ID! UC_SubjectIdentification.SeeSubjectList_01!Summary! User(is(able(see(list(of(subjects(Related!UML!Diagrams! Figure(8:(Use(Case(Diagram(b(Subject(Identification(Priority! Essential(Use!Frequency! Always(Direct!Actors! Treating(Physician(Prereq./Trigger! At(least(one(subject(is(available.(Main!Success!Use!Case!Scenario!


rights.(Studies(are(listed(by(ID,(sponsor,(title(or(last(update.(3. User(selects(study.(4. System(lists(and(User(browses(through(potentially(eligible(subjects(

(POTENTIAL(CANDIDATE).(Subjects(are(listed(by(ID,(name,(birthday(or(date(of(identification.(

(Alternative!Use!Case!Scenario!Extensions!

(


7.3.5 See Subject Details Use(Case(ID! UC_SubjectIdentification.SeeSubjectDetails_01!Summary! User(is(able(see(details(of(subject(Related!UML!Diagrams! Figure(8:(Use(Case(Diagram(b(Subject(Identification(Priority! Expected(Use!Frequency! Always(Direct!Actors! Treating(Physician(Prereq./Trigger! At(least(one(subject(is(available.(Main!Success!Use!Case!Scenario!


rights.(Studies(are(listed(by(ID,(sponsor,(title(or(last(update.(3. User(selects(study.(4. System(lists(and(User(browses(through(potentially(eligible(subjects(

(POTENTIAL(CANDIDATE).(Subjects(are(listed(by(ID,(name,(birthday(or(date(of(identification.(

5. User(selects(to(see(details(of(subject(6. Details(are(displayed.(


4.(No(details(are(displayed(but(Msg.(with(reason((no(access(to(EHR(or(Database(etc...)((

Notes!and!Questions! This(might(be(only(a(link(to(the(EHR(System(that(opens(in(another(window(or(might(be(opened(e.g.(in(an(iFrame.(

7.3.6 Notify Treating Physician(s) Use(Case(ID! UC_!SubjectIdentification.NotifyTreatingPhysician_01!Summary! Investigator(forwards(candidate(list(to(Treating(Physician(Related!UML!Diagrams! Figure(8:(Use(Case(Diagram(b(Subject(Identification(

( (

(


(

Priority! Essential(Use!Frequency! Always(Direct!Actors! Investigator(Prereq./Trigger! Result(set(is(available.(

User(has(access(right(to(read(query.(Main!Success!Use!Case!Scenario!

1. Investigator(selects(result(set(of(query(2. List(of(POTENTIAL(CANDIDATE(subjects(are(sent(to(Treating(Physician(3. Investigator(gets(confirmation(that(list(has(been(sent(


No(results(are(available.(


7.3.7 Export List of Subjects Use(Case(ID! UC_!SubjectIdentification.ExportSubjectList_01!Summary! Investigator(is(able(to(export(candidate(list(Related!UML!Diagrams! Figure(8:(Use(Case(Diagram(b(Subject(Identification(Priority! Expected(Use!Frequency! Sometimes(Direct!Actors! Investigator(Prereq./Trigger! Result(set(is(available.(

User(has(access(right(to(read(query.(Main!Success!Use!Case!Scenario!

1. Investigator(selects(result(set(of(query(2. User(selects(format(of(export(3. List(of(POTENTIAL(CANDIDATE(subjects(is(exported(to(file/email(4. Investigator(gets(confirmation(that(list(has(been(exported(


No(results(are(available.(

Notes!and!Questions! Export(as(*.pdf,(*.csv(

(

( (

(


(

7.4. Mockups

(

Figure!9:!MockXup!X!Subject!Identification!

(

( (

(


(

8. Subject Recruitment The(subject(recruitment(takes(place(on(the(local(EHR4CR(workbench.((

8.1. Scope of Subject Recruitment After(the(subject(has(been(identified,(the(candidate(list(is(generated(and(the(subject(recruitment(starts.(Additional(Information(is(pulled(from(the(EHR4CR(platform(to(the(Local(Workbench(where(the(

Investigator(can(rerun(the(query(according(to(his(needs.(A(list(of(“POTENTIAL_CANDIDATE”s(is(forwarded(to(the(Treating(Physician(who(starts(to(check(the(list(and(notifies(the(subject.(After(this(step(counts(of(the(subject(are(reported(back(to(the(EHR4CR(platform(and(a(list(of(“NOTIFIED”(and(

“DENIED”(is(accessible(by(the(Investigator.((

In(the(next(step,(the(Investigator(meets(the(subject(and(signs(the(Informed(Consent.(The(new(status(is(set(by(the(Investigator(and(also(reported(back(to(the(EHR4CR(platform.(If(the(subject(consents(to(take(part(in(the(study(the(status(will(be(“INCLUDED”.(Whereas(the(Investigator(can(also(sign(up(the(

subject(for(a(screening((“SCREENING”)(or(if(the(subject(does(not(agree(to(the(Informed(Consent(the(status(“DENIED”(is(reported(to(the(EHR4CR(platform.((

As(well(as(on(denied(there(is(a(second(status(with(a(dropout(reason(set(by(the(Investigator(for(why(the(subject(is(dropping(out(and(if(he(wants(to(get(informed(again(about(other(studies(or(might(not.((

After(the(screening(phase(there(is(the(option(to(set(the(subject(status(might(be(changed(to(“INCLUDED”(or(“DENIED”(again.((

(

(

( (

(


(

8.2. Use Case Diagram – Subject Recruitment

(

Figure!10:!Use!Case!Diagram!X!Subject!Recruitment!

8.3. Use Case Descriptions – Subject Recruitment

8.3.1 Show Dashboard Use(Case(ID! UC_SubjectRecruitment.ShowDashboard_01!Summary! User(is(able(see(list(of(subjects(and(recruitment(status(on(Dashboard(Related!UML!Diagrams! Figure(10:(Use(Case(Diagram(b(Subject(Recruitment(Priority! Expected(Use!Frequency! Always(Direct!Actors! Investigator(Prereq./Trigger! At(least(one(study(with(one(subject(is(available.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(subject(recruitment((dashboard).(2. User(browses(through(list(of(available(studies.(Numbers(of(potential,(

screened(and(recruited(subjects(are(listed((update(since(last(login)(Alternative!Use!Case!Scenario!Extensions!

(

Notes!and!Questions! A(history(is(kept(to(track(the(changes(in(recruitment(and(subject(states(

8.3.2 Change study specific status of Subject Use(Case(ID! UC_SubjectRecruitment.ChangeStudySpecificSubjectStatus_01!Summary! User(is(able(to(change(the(status(of(a(subject.(Related!UML!Diagrams! Figure(10:(Use(Case(Diagram(b(Subject(Recruitment(Priority! Essential(Use!Frequency! Always(Direct!Actors! Investigator(Prereq./Trigger! At(least(one(subject(is(available.(

( (

(


(

User(has(access(right(to(change(status(of(subject(query.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(subject(recruitment.(2. User(browses(through(list(of(available(studies,(depending(on(access(

rights.(Studies(are(listed(by(ID,(title,(status(or(last(update.(3. User(selects(study.(4. System(presents(and(user(browses(through(list(of(subjects.(Subjects(

are(listed(by(ID,(name,(birthday,(status(or(last(update.(5. User(selects(subject.(6. User(changes(status(of(subject.(Available(states(are:(

a. DENIED(b. RECRUITED(c. REVIEWED(d. SCREENING(e. SCREENING(SUCCEED(f. SCREENING(FAILED(g. INCLUDED(

7. User(confirms(status(change.(Alternative!Use!Case!Scenario!Extensions!

(


8.3.3 Change additional status of Subject Use(Case(ID! UC_SubjectRecruitment.ChangeAdditionalSubjectStatus_01!Summary! User(is(able(to(change(the(status(of(a(subject.(Related!UML!Diagrams! Figure(10:(Use(Case(Diagram(b(Subject(Recruitment(Priority! Essential(Use!Frequency! Always(Direct!Actors! Treating(Physician(Prereq./Trigger! At(least(one(subject(is(available.(

User(has(access(right(to(change(status(of(subject.(Main!Success!Use!Case!Scenario!

1. User(navigates(to(subject(identification.(2. User(browses(through(list(of(available(subjects,(depending(on(access(

rights.(Subjects(are(listed(by(ID,(status(or(last(update.(3. User(selects(subject.(4. User(changes(status(of(subject((

A. WON’T(PARTICIPATE(B. WON’T(EVER(PARTICIPATE(C. CURRENTLY(PARTICIPATING(

5. User(confirms(status(change.(Alternative!Use!Case!Scenario!Extensions!

(

Notes!and!Questions! An(entry(in(the(audit(trail(is(created.(Status(changes(need(to(be(time(stamped.(

8.3.4 Enter Recruitment Denied Reason Use(Case(ID! UC_!SubjectRecruitment.EnterRecruitmentDeniedReason_01!Summary! The(Investigator(enters(a(reason(why(the(subject(denied(to(take(part(in(the(

study(Related!UML!Diagrams! Figure(10:(Use(Case(Diagram(b(Subject(Recruitment(Priority! Expected(Use!Frequency! Often(

( (

(


(

Direct!Actors! Investigator(Prereq./Trigger! A(list(of(subjects(is(available.(

User(has(rights(to(modify(status.(Main!Success!Use!Case!Scenario!


rights.(Studies(are(listed(by(ID,(title,(status(or(last(update.(3. System(presents(and(user(browses(through(subject(list(for(the(

selected(study.(Subjects(are(listed(by(ID,(name,(birthday,(status(or(last(update.(

4. User(can(filter(list(of(subject(according(to(status.(5. User(selects(specific(subject.(6. User(adds(reason(from(list(why(subject(is(not(recruited(

a. CRITERIA(NOT(MET(b. INVESTIGATOR(MAX(REACHED(c. INVESTIGATOR(REFUSAL(d. SUBJECT(LOGISTIC(e. SUBJECT(PREV(TRIAL(f. SUBJECT(BENEFIT(g. SUBJECT(COMMUNICATION(h. SUBJECT(OCCUPIED(i. SUBJECT(PROCEDURE(j. SUBJECT(REFUSAL(k. SUBJECT(DECEASED(

7. Free(text(field(is(now(available(for(further(details(8. User(saves(changes(and(is(directed(to(subject(list(


6.(User(cancels(and(is(directed(to(subject(list(

Notes!and!Questions! Subject(study(related(status(is(set(to(“DENIED”(by(the(system(On(the(free(text(field(it(needs(to(be(ensured(that(no(subject(ID(data(is(entered(

8.3.5 Export List of Subjects Use(Case(ID! UC_!SubjectRecruitment.ExportSubjectList_01!Summary! Investigator(exports(list(of(subjects(Related!UML!Diagrams! Figure(10:(Use(Case(Diagram(b(Subject(Recruitment(Priority! Expected(Use!Frequency! Sometimes(Direct!Actors! Investigator(Prereq./Trigger! A(list(of(subjects(is(available.(

User(has(access(right(to(export(subject(list.(Main!Success!Use!Case!Scenario!


rights.(Studies(are(listed(by(ID,(title,(status(or(last(update.(3. User(selects(study.(4. System(presents(and(user(browses(through(subjects.(Subjects(are(

listed(by(ID,(name,(birthday,(status(or(last(update.(5. User(can(filter(list(of(subject(according(to(status.(6. User(requests(export(of(subjects(list.(7. List(of(subjects(is(exported(to(file.(8. User(get(confirmation(that(list(has(been(exported.(


(

Notes!and!Questions! Export(as(*.pdf,(*.csv((

( (

(


(

8.4. Mock-ups

(

Figure!11:!MockXup!X!Subject!Recruitment!

!

( (

(


(

9. User Management at Local Workbench

9.1. Scope of User Management Due(the(fact(that(we(have(a(dedicated(Local(Workbench(for(Subject(Identification(and(Recruitment,(user(and(role(management(is(in(the(responsibility(of(the(local(site.(To(manage(users(and(their(

associated(roles(the(position(of(a(Local(Workbench(Administrator(has(to(be(established.((The(tasks(of(the(Local(Workbench(Administrator(comprises(user(management((e.g.(add(new(users,(edit(current(users,(remove(users)(and(role(management((e.g.(change(the(role(or(assign(one(or(more(roles(to(a(

user).((

9.2. Use Case Diagram – User Management

!

Figure!12:!Use!Case!Diagram!X!User!Management!

( (

(


(

9.3. Use Case Descriptions – User Management

9.3.1 Add User Use(Case(ID! UC_UserManagement.Add_User_01!Summary! User(can(add(users(Related!UML!Diagrams! Figure(12:(Use(Case(Diagram(b(User(Management(Priority! Essential(Use!Frequency! Often(Direct!Actors! Local(Workbench(Administrator(Prereq./Trigger! User(has(access(right(to(add(users(Main!Success!Use!Case!Scenario!

1. User(navigates(to(user(management.((2. User(creates(a(new(user.(3. User(enters(new(user((meta)(information(

• Surname,(• First(name,(• Phone(number(• EbMail(address(and(• Organisation(

4. User(confirms(creation(of(new(user(5. Systems(confirms(creation(of(new(user(


3. User(does(not(enter(all(of(the(required(fields((correctly)(4. System(tells(user(about(missing(or(wrong(entries,(marks(

missing/wrong(entries(and(presents(“new(user”(dialog(again(Notes!and!Questions! An(entry(in(the(audit(trail(is(created.(

Should(the(new(user(get(an(email?(

9.3.2 Edit User Use(Case(ID! UC_UserManagement.ManageUsers.Edit_User_01!Summary! User(can(edit(user(information(Related!UML!Diagrams! Figure(12:(Use(Case(Diagram(b(User(Management(Priority! Essential(Use!Frequency! Sometimes(Direct!Actors! Local(Workbench(Administrator(Prereq./Trigger! User(has(access(right(to(edit(user(information(Main!Success!Use!Case!Scenario!

1. User(navigates(to(user(management.((2. User(browses(through(available(users(3. User(selects(a(user(4. User(is(updating((meta)(information;(e.g.(Name(5. User(accepts(changes(6. System(confirms(changes.(7. User(is(saved(by(the(system(as(a(new(version.(


3. User(deletes(required(fields(or(changes(them(to(be(wrong.(4. User(accepts(changes.(5. System(tells(user(about(missing(or(wrong(entries,(marks(

missing/wrong(entries(and(presents(“edit(user”(dialog(with(latest(version(again.(


9.3.3 Remove User Use(Case(ID! UC_UserManagement.Remove_User_01!Summary! User(can(delete(user(

( (

(


(

Related!UML!Diagrams! Figure(12:(Use(Case(Diagram(b(User(Management(Priority! Essential(Use!Frequency! Sometimes(Direct!Actors! Local(Workbench(Administrator(Prereq./Trigger! At(least(two(users(are(available(

User(has(access(right(to(remove(user(Main!Success!Use!Case!Scenario!

1. User(navigates(to(user(management.((2. User(browses(through(available(users(3. User(selects(a(user(4. User(confirms(remove(of(a(user(5. User(is(saved(by(the(system(as(a(new(version(with(status(“removed”.(


(


9.3.4 Change Password Use(Case(ID! UC_UserManagement.ChangePassword_01!Summary! User(wants(to(change(his(password(or(is(forced(by(the(system(to(change(his(

password,(e.g.(every(3(month.(Related!UML!Diagrams! Figure(12:(Use(Case(Diagram(b(User(Management(Priority! Essential(Use!Frequency! Sometimes(Direct!Actors! All(Prereq./Trigger! User(is(registered.(Main!Success!Use!Case!Scenario!

1. The(user(wants(or(is(forced(to(change(his(password.(2. User(enters(his(old(password(3. User(enters(new(password((twice)(4. User(password(is(accepted(


• User’s(new(password(does(not(correspond(to(the(system’s(password(policy(

• Entered(old(password(is(not(correct(Notes!and!Questions! 1. New(created(users(get(an(system(generated(password(with(the(

activation/notification(email(2. New(users(get(a(link(with(the(activation/notification(email(to(activate(

their(account(and(is(prompted(to(enter(a(new(password(to(activate(their(account(

9.3.5 Request for New Password Use(Case(ID! UC_UserManagement.RequestNewPassword_01!Summary! User(has(forgotten(his(password(and(sends(a(request(for(a(new(password(Related!UML!Diagrams! Figure(12:(Use(Case(Diagram(b(User(Management(Priority! Expected(Use!Frequency! Sometimes(Direct!Actors! All(Prereq./Trigger! User(is(registered.(Main!Success!Use!Case!Scenario!

1. User(enters(user(name(email(address)(2. User(sends(a(request(for(a(new(password(3. User(gets(an(email(with(new(system(generated(password.(4. User(enters(new(password(and(is(prompted(to(change(system(

generated(password.(Alternative!Use!Case! (

( (

(


(

Scenario!Extensions!Notes!and!Questions! (

9.3.6 Create Role Use(Case(ID! UC_UserManagement.CreateRole_01!Summary! User(can(create(roles(Related!UML!Diagrams! Figure(12:(Use(Case(Diagram(b(User(Management(Priority! Essential(Use!Frequency! Often(Direct!Actors! Local(Workbench(Administrator(Prereq./Trigger! User(has(access(right(to(add(roles(Main!Success!Use!Case!Scenario!

1. User(navigates(to(user(management.((2. User(creates(a(new(role(3. User(enters(new(role((meta)(information(

a. Name(b. Role(description(

4. User(confirms(creation(of(new(role(Alternative!Use!Case!Scenario!Extensions!

3. Required(fields(are(not(filled(4. Error(message(appears(


9.3.7 Modify Role Use(Case(ID! UC_UserManagement.ModifyRole_01!Summary! User(can(modify(role(information(Related!UML!Diagrams! Figure(12:(Use(Case(Diagram(b(User(Management(Priority! Essential(Use!Frequency! Often(Direct!Actors! Local(Workbench(Administrator(Prereq./Trigger! At(least(one(role(is(available(

User(has(access(right(to(edit(role(information(Main!Success!Use!Case!Scenario!

1. User(navigates(to(user(management.((2. User(browses(through(available(roles(3. User(selects(a(role(4. User(updates(role((meta)(information;(e.g.(Name(5. User(accepts(changes(6. System(stores(role(as(a(new(version(


4. Required(fields(are(not(filled(5. Error(message(appears(

9.3.8 Remove Role Use(Case(ID! UC_UserManagement.RemoveRoles_01!Summary! User(can(remove(roles(Related!UML!Diagrams! Figure(12:(Use(Case(Diagram(b(User(Management(Priority! Essential(Use!Frequency! Often(Direct!Actors! Local(Workbench(Administrator(Prereq./Trigger! At(least(two(roles(are(available(

User(has(access(right(to(remove(roles(Main!Success!Use!Case!Scenario!

1. User(navigates(to(user(management.((2. User(browses(through(available(roles(3. User(selects(a(role(

( (

(


(

4. User(confirms(remove(of(a(role(5. Role(is(saved(by(the(system(as(a(new(version(with(status(“removed”.(


3. User(selects(the(role(“Local(Workbench(Administrator”(4. System(disables(the(possibility(to(remove(the(selected(role(


9.3.9 Assign User to Role Use(Case(ID! UC_UserManagement.AssignUserToRole_01!Summary! User(can(assign(users(to(roles(Related!UML!Diagrams! Figure(12:(Use(Case(Diagram(b(User(Management(Priority! Essential(Use!Frequency! Often(Direct!Actors! Local(Workbench(Administrator(Prereq./Trigger! User(has(access(right(to(assign(users(to(roles(Main!Success!Use!Case!Scenario!

1. User(navigates(to(user(management.((2. User(browses(through(available(roles(3. User(selects(one(role(4. User(selects(one(or(more(users((5. User(assigns(user(s)(to(selected(role(


(


9.3.10 Withdraw User from Role Use(Case(ID! UC_UserManagement.WithdrawUserFromRole_01!Summary! User(can(withdraw(users(from(role(Related!UML!Diagrams! Figure(12:(Use(Case(Diagram(b(User(Management(Priority! Essential(Use!Frequency! Often(Direct!Actors! Local(Workbench(Administrator(Prereq./Trigger! User(has(access(right(to(withdraw(users(from(role(Main!Success!Use!Case!Scenario!

1. User(navigates(to(user(management.((2. User(browses(through(available(roles(3. User(selects(one(role(4. User(selects(one(or(more(users(5. User(withdraws(user(s)(from(selected(role(


(


9.3.11 Assign Access Rights to Role Use(Case(ID! UC_UserManagement.AssignAccessRights_01!Summary! User(can(assign(access(rights(to(roles(Related!UML!Diagrams! Figure(12:(Use(Case(Diagram(b(User(Management(Priority! Essential(Use!Frequency! Often(Direct!Actors! Local(Workbench(Administrator(Prereq./Trigger! User(has(access(right(to(assign(Access(rights(to(roles(Main!Success!Use!Case!Scenario!

1. User(navigates(to(user(management.((2. User(browses(through(available(roles(

( (

(


(

3. User(selects(a(role(4. User(browses(through(available(access(rights(5. User(selects(one(or(more(access(rights(6. User(assigns(access(rights(to(selected(role(


(


9.3.12 Withdraw Access Rights from Role Use(Case(ID! UC_UserManagement.WithdrawAccessRights_01!Summary! User(can(withdraw(access(rights(from(roles(Related!UML!Diagrams! Figure(12:(Use(Case(Diagram(b(User(Management(Priority! Essential(Use!Frequency! Often(Direct!Actors! Local(Workbench(Administrator(Prereq./Trigger! User(has(access(right(to(withdraw(Access(Rights(from(roles(Main!Success!Use!Case!Scenario!

1. User(navigates(to(user(management.((2. User(browses(through(available(roles(3. User(selects(one(role(4. User(browse(through(available(access(rights(5. User(selects(one(or(more(access(rights(6. User(withdraws(access(rights(from(selected(role(


5. User(selects(the(last(access(right(6. System(disables(the(possibility(to(remove(the(selected(role(


9.3.13 Assign User to Study Use(Case(ID! UC_UserManagement.AssignUserToStudy_01!Summary! User(can(assign(users(to(study(Related!UML!Diagrams! Figure(12:(Use(Case(Diagram(b(User(Management(Priority! Essential(Use!Frequency! Often(Direct!Actors! Local(Workbench(Administrator(Prereq./Trigger! User(has(access(right(to(assign(users(to(study(Main!Success!Use!Case!Scenario!

1. User(navigates(to(user(management.((2. User(browses(through(available(studies(3. User(selects(a(study(4. User(browses(through(available(users(5. User(selects(one(or(more(users(6. User(assigns(access(users(to(selected(study(


(


9.3.14 Withdraw User from Study Use(Case(ID! UC_UserManagement.WithdrawUserFromStudy_01!Summary! User(can(withdraw(users(from(study(Related!UML!Diagrams! Figure(12:(Use(Case(Diagram(b(User(Management(Priority! Essential(Use!Frequency! Often(Direct!Actors! Local(Workbench(Administrator(

( (

(


(

Prereq./Trigger! User(has(access(right(to(withdraw(users(from(study(Main!Success!Use!Case!Scenario!

1. User(navigates(to(user(management.((2. User(browses(through(available(studies(3. User(selects(one(study(4. User(browse(through(available(users(5. User(selects(one(or(more(users(6. User(withdraws(users(from(selected(study(


(


9.4. Mockups

(

Figure!13:!MockXup!X!User!Management!

( (

(


(

10. Data Requirements

10.1. Local workbench development Sites(or(hospitals(can(use(the(EHR4CR(provided(workbench(or(enhance(their(hospital(specific(solutions(to(meet(EHR4CR(requirements.(

It(is(important(that(the(Patient(Recruitment(SRS(is(used(as(a(base(for(the(development(process(and(all(

relevant(data(is(reported(back(to(the(EHR4CR(platform.((

10.2. High Level Information Model

(Figure!14:!Hierarchy!of!concepts!

10.3. Access Rights

10.3.1 Study Manager Study!MGR S(hare)! C(reate)! R(ead)! E(dit)! D(elete)!

Study( x( x( x( x( x(

Participation( x( x( x( x( x(

Query( x( x( x( x( x(

IRbReports( ( ( x( ( (

Table!6:!Access!Rights!of!the!Study!Manager!

( (

(


(

10.3.2 Data Relation Manager DSM S(hare)! C(reate)! R(ead)! E(dit)! D(elete)!

Participation( ( ( x( x( (

IRbReport((Sitebbased)(

x( ( x( ( (

Table!7:!Access!Rights!of!the!Data!Relation!Manager!

10.3.3 Investigator Investigator! S(hare)! C(reate)! R(ead)! E(dit)! D(elete)!

Study( ( ( x( ( (

Query( x( ( x( x( (

Subject(state( ( ( x( x( (

Table!8:!Access!Rights!of!the!Investigator!

10.3.4 Treating Physician Treating!

Physician!

S(hare)! C(reate)! R(ead)! E(dit)! D(elete)!

Study( ( ( x( ( (

Query( ( ( x( ( (

IRbReports( ( ( x( ( (

Subject(

state(

( ( x( x( (

Table!9:!Access!Rights!of!the!Treating!Physician!

10.3.5 Workbench Administrator Study!MGR! S(hare)! C(reate)! R(ead)! E(dit)! D(elete)!

User( ( x( x( x( x(

Role( ( x( x( x( x(

Table!10:!Access!of!the!Workbench!Administrator!

( (

(


(

10.4. Clinical Study Attribute! Type!

Key(identifier(information((ID)! ID(

Brief(description! Text(

Name(of(the(clinical(study! Text(

EudraCT(number( Numeric(

Author( Link(to(user(s),(User(ID(s)(

Owner/Sponsor?! Link(to(user/organization,(User(ID(or(Organization(ID(

Last(editor! Link(to(user,(User(ID(

Last(modification(date! Date(

Status! Linked(status,(Status(ID(

Version(no.! Numeric(

Link(to(audit(trail! Link(to(audit(trail(query),(Audit(Trail(ID(

One(or(more(associated(protocols! List(of(links(to(protocols,(protocol(ID(

One(or(more(associated(protocol(feasibility(studies!

List(of(links(to(protocol(feasibility(studies,(protocol(feasibility(study(ID(

Creation(date! Date(

One(or(more(participating(sites! List(of(links(to(sites((organisations),(organisation(ID(

Table!11:!attributes!of!a!clinical!study!

10.5. Role Based Access Control for Central Platform Basic!role/!Functional!

area!Identification!and!

Recruitment!Services!User!Management!

Study(Manager! x( (

( (

(


(

Data(Relation(Manager! x( (

Investigator! ( (

Treating(Physician! ( (

Local(Workbench(

Administrator!( (

Table!12:!Data!Requirements!X!RBAC!to!Functional!Areas!

10.6. Role Based Access Control for Local Subject Identification and Recruitment Workbench

Basic!role/!Functional!area!

Subject!Identification! Subject!Recruitment! User!Management!

Investigator! x( x( (

Treating(Physician! x( x( (

Local(Workbench(Administrator!

( ( x(

Table!13:!Data!Requirements!X!RBAC!to!Functional!Areas!

10.7. States of a site (study related) Attribute! Description!

PENDING(AUTHORIZATION! status(that(is(set(automatically(after(request(has(been(sent(to(site(

PARTICIPATING! site(is(willing(to(participate(in(study(

NOT(PARTICIPATING! site(does(not(want(to(participate(in(study(

READY(TO(GO! all(documents(have(been(signed(and(sent(back(to(Study(Manager((outside(EHR4CR)(and(site(is(ready(to(go(

Table:!attributes!for!states!of!a!clinical!study!

( (

(


(

10.8. States of a subject

10.8.1 Study related subject states (1st level states) Attribute! Description!

POTENTIAL(CANDIDATE! The(subject(was(recognized(by(the(system(as(a(potential(candidate.(

CANDIDATE! It(was(confirmed(that(the(subject(is(a(candidate(by(the(Treating(

Physician.(

NOTIFIED! When(the(subject(knows(that(there(is(a(study(he(could(probably(

participate(in(and(has(given(permission(to(the(Investigator(to(see(

her/his(patient(data(and(to(contact(her/him(for(further(recruitments(

steps.(

DENIED! Subject(does(not(want(to(take(part(in(the(study.(

SCREENING! Screening(as(used(here(describes(a(washout(phase(of(a(patient(

SCREENING(FAILED! For(particular(reason(s)(the(screening(was(not(successful.(

INCLUDED! The(patient(has(been(successfully(included(into(the(study(

Table!14:!study!related!subject!states!(1st!level!–!states)!of!subject!

The(Study(related(subject(states(are(based(on(the(BRIDGbModel(that(can(be(accessed(on(

http://www.bridgmodel.org/.(The(Study(related(subject(states(have(been(slightly(modified(to(fit(in(

the(EHR4CR(–(Patient(Recruitment(SRS.((

(

!

Figure!15:!Subject!States!in!logical!order!

10.8.2 Additional subject states (2nd level states) Attribute! Description!

( (

(


(

CURRENTLY(PARTICIPATING! (

WON’T(PARTICIPATE! (

WON’T(EVER(PARTICIPATE! (

Table!15:!patient!level!information!states!(2nd!level!–!states)!of!subject!

10.8.3 Subject “DENIED” Reasons Attribute! Description!

CRITERIA(NOT(MET! Inclusion / Exclusion Criteria of the protocol not fulfilled

(e.g. came up during talk to patient, latest lab values)

INVESTIGATOR(MAX(REACHED! Investigator reached maximum number of patients allocated to site

INVESTIGATOR(REFUSAL! Investigator Refusal ( for medical reasons or for other reasons)

Doubts of Investigator that patient will be compliant (any reason)

SUBJECT(LOGISTIC! Logistic Reasons

• e.g. not able to follow trial time schedule (e.g. vacation) • e.g. too long travelling required

SUBJECT(PREV(TRIAL! Not enough time elapsed since previous participation to a Clinical Study

SUBJECT(BENEFIT! Lack of direct benefit to patient

SUBJECT(COMMUNICATION! Problems caused by language/understanding

SUBJECT(OCCUPIED! Patient still under treatment in another Clinical study

SUBJECT(PROCEDURE! Protocol procedures not acceptable to patient

SUBJECT(REFUSAL! Patient refusal

( (

(


(

• e.g. private issues • e.g. don’t like the trial

SUBJECT(DECEASED( Patient died after signing Informed Consent

Table!16:!Reason!States!of!not!being!recruited!

10.9. Identification and Recruitment Services Attributes! Description!

Key(identifier(information((ID)! ID(


Name(of(the(protocol Text

Eligibility(Criteria Textbox,(Checklist Author Link(to(user(s)(and(User(IDs(

Owner Link(to(user/organization,(User(ID/Organization(ID Last(editor Link(to(user,(User(ID Last(modification(date Date Status Linked(status,(Status(ID Version(no. Numeric Link(to(audit(trail Link(to(audit(trail,(Audit(Trail(ID One(or(more(associated(queries

List(of(links(to(queries,(query(ID

Creation(date( Date Table!17:!attributes!of!Identification!and!Recruitment!Services!

10.10. Subject Identification Attributes! Description!

Key(identifier(information((ID)!

ID(

( (

(


(


Name(of(the(subject! Text(

Eligibility(Criteria! Text(

Last(editor! Link(to(user,(User(ID(

Last(changes! Date(

Investigator! Text(

Treating(Physician! Text(

Table!18:!attributes!of!subject!identification!

(

( (

(


(

11. Tables and Figures Table(1:(Developed(Documents .............................................................................................................. 8(Table(2:(Literature/Reference(Documents ........................................................................................... 10(

Table(3:(Template(for(Use(Cases........................................................................................................... 11(Table(4:(Naming(Conventions ............................................................................................................... 12(Table(5:(New(Actor(Descriptions........................................................................................................... 14(

Table(6:(Access(Rights(of(the(Study(Manager ....................................................................................... 50(Table(7:(Access(Rights(of(the(Data(Relation(Manager........................................................................... 51(Table(8:(Access(Rights(of(the(Investigator............................................................................................. 51(

Table(9:(Access(Rights(of(the(Treating(Physician................................................................................... 51(Table(10:(Access(of(the(Workbench(Administrator............................................................................... 51(Table(11:(attributes(of(a(clinical(study .................................................................................................. 52(

Table(12:(Data(Requirements(b(RBAC(to(Functional(Areas.................................................................... 53(Table(13:(Data(Requirements(b(RBAC(to(Functional(Areas.................................................................... 53(Table(14:(study(related(subject(states((1st(level(–(states)(of(subject..................................................... 54(

Table(15:(patient(level(information(states((2nd(level(–(states)(of(subject ............................................. 55(Table(16:(Reason(States(of(not(being(recruited .................................................................................... 56(Table(17:(attributes(of(Identification(and(Recruitment(Services .......................................................... 56(

Table(18:(attributes(of(subject(identification........................................................................................ 57((

Figure(1:(Sequence(diagram(of(Subject(Identification(and(Recruitment .............................................. 15(Figure(2:(new(functional(overview(of(EHR4CR(platform(interacting(with(EHR4CR(local(workbench(

(Stickman(Source:(http://openclipart.org/) .......................................................................................... 16(Figure(3:(Use(Case(Diagram(b(Identification(and(recruitment(services ................................................. 19(Figure(4:(Mockbup(b(Study(Dashboard((Data(Relation(Manager) .......................................................... 28(

Figure(5:(Mockbup(b(Study(Dashboard((Study(Manager)....................................................................... 29(Figure(6:(Mockbup(b(Link(to(Feasibility .................................................................................................. 30(Figure(7:(Mockbup(b(Show(Queries........................................................................................................ 31(

Figure(8:(Use(Case(Diagram(b(Subject(Identification ............................................................................. 33(Figure(9:(Mockbup(b(Subject(Identification............................................................................................ 37(Figure(10:(Use(Case(Diagram(b(Subject(Recruitment............................................................................. 39(

Figure(11:(Mockbup(b(Subject(Recruitment ........................................................................................... 42(Figure(12:(Use(Case(Diagram(b(User(Management ............................................................................... 43(Figure(13:(Mockbup(b(User(Management .............................................................................................. 49(

Figure(14:(Hierarchy(of(concepts .......................................................................................................... 50(Figure(15:(Subject(States(in(logical(order.............................................................................................. 54((

EHR4CR!!

Annex 3 - Evaluation of the EHR4CR Pilots

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