www.cineca.it 1© CINECA 2012

CINECA web based platformIn supporting of Ethics Committee

activities

July 2013

www.cineca.it 2

Ethics Committees platformThe project

Establish a monitoring and evaluation system to ensure quality and achievement of the IRB to improve research processes and operations.

The aim is to provide Ethics committees with a web based platform for the integrated management of IRB activities, supporting harmonization, optimization and transparency of procedures and improving the efficiency of the process.

www.cineca.it 3

Ethics committees Needs (1)

• to employ administrative tools for organizing meetings and secure storing of minutes, resolutions and results

• to support networking of members involved in the IRB process (sponsors, investigators, IRB members, IRB secretariat, ..) by offering data collection and data sharing directly form one sources

• to create one centralized registry for each Ethics Committee containign all the information and all the documents related to clinical research

www.cineca.it 4

• to support harmonization and standardization of procedures, improve transparency and efficiency of monitoring and evaluation of clinical research

• to employ tools for scientific and economic monitoring of studies (study follow-up, results and publications, SAE, amendments, study costs and payments, …)

• to use tools and indicators for the analysis and planning of activities at local level and at central level (Ethics Committee, Hospital, Region …) in an integrated and transversal way

Ethics committees Needs (2)

www.cineca.it 5

Platform Users

• Sponsors

• Ethics Committees Secretariat

• Ethics Committees members

• Principal Investigator

• Directors of Hospitals and Health Units

• Pharmacies

• Local competent authorities

• …

www.cineca.it 6

Platform modules

The platform is composed of several integrated web modules, offering all functionalities to manage the entire IRB process.

Core modules

Registry of all clinical studies

Workflow management system

Meetings organization

Scientific monitoring

Additional modules

Administrative and economic monitoring

Pharmacy activities management

EC Public Web Portal

www.cineca.it 7

Platform schema

Workflow management system

Centralized Registry of all clinical studies

Mee

tings

or

gani

zatio

n

Adm

inis

trat

ive

and

econ

omic

m

onito

ring

Sci

entif

ic

mon

itorin

gEC

Secretariat

EC members

Directors of Hospitals

and Health Units

Investigators

Research Units

EC Public Web Portal

Sponsors

Local competentauthorities

Pha

rmac

y m

anag

emen

t

Pharmacy

www.cineca.it 8

Workflow management system and Registry of all clinical studies

The main aim of the platform is to create an unique centralized registry of all ECs

clinical studies recording all informations and documents of each studies:• Interventional studies• Observational studies• Studies involving drugs• Studies involving medical devices• Biological studies• ….

The Registry is constantly updated by the workflow management system, that manages and monitors the entire process from initial application submission to ECs review and approval, and from first patient enrollment to the publication of results.

www.cineca.it 9

Meetings Organization Module

• Electronic Calendar of meetings• Invitations for members and external experts (via

mail, sms, etc)• Automatic agenda and minutes of meetings using

information available on registered clinical studies• Ethics Committees members access to reports and

comments, or to confirm their participation to meetings, etc

• Meetings attendance registry

www.cineca.it 10

Scientific Monitoring Module

This module includes all functionalities for collection and management of all necessary information necessary for monitoring the progress of a clinical study, from Ethics Committee approval to study closure and publication of results.

In particular, the platform manages the following

information:• Study Follow-up (accrual, annual report, study

closure)• Study amendments, with relative Ethics Committee

review process management • Serious Adverse Events (SAE)• Study results and publications

www.cineca.it 11

Data analysis and Reporting tools

The platform offers advanced tools for data analysis and quick information retrieval.

Information entered in the platform are integrated to allow global monitoring of research activities.

For example– OLAP Reporting– Predefined reports – Studies progress report– Information dashboards– …

Availability of information will be based on user roles and profiles.

www.cineca.it 12

Example of predefined reports

Some reports are already be setted up in the platform

For example, studies distribution for:• status (to be approved, open, closed, etc)• type of study • sponsor• therapeutic area and pathology• participating sites• …

And reports on study progress monitoring , such as:• time for EC review and approval• patients enrollment (enrolled patients vs. expected

patients, enrolment progress)• actual duration vs. expected duration• …

www.cineca.it 13

Service delivery model for Ethics Committees

The proposed service is offered as SaaS (Software-as-a-Service), a cloud model service where software is delivered via the Internet to remove all burdens of hardware and software implementation and maintenance from users. Main advantages:• enhanced flexibility in updating the service (e.g new regulations) and its standards and dictionaries (e.g. ICD IX e MedDRA).• Networks of users can easily be extended to new participants• high reliability, availability, security and integrity of information, constant and transparent technological maintenance and evolution (Data Center: Cineca)

www.cineca.it 14

Information Security

•High level of security and confidentiality of information is granted by the use of AXMR®  (“Advanced eXtended Multicenter Research”) developed by Cineca coupled with http e  SSL protocols and password protected access, thus ensuring data transmission on a secure and encrypted channel.

•The IT infrastructure, its applications and data are hosted at the Cineca Data Center to grant daily backup and disaster recovery

• The quality management system is certified ISO 9001:2000 and the information security management system is certified ISO 27001:2005

www.cineca.it 15

Cineca platform supporting

Makerere SHS IRB processes

www.cineca.it 16

Cineca platform for Makerere SHS IRB

Cineca will use the Italian model for Ethics Committee for the SHS IRB.

The system will include the following modules:• Registry of all clinical studies• Workflow management system • Meetings organization • Scientific monitoring (study follow up, annual reports, SAE,

amendments, results and publications)

In the phase I of the project, Cineca will  provide a system  where the Secretariat will enter the application information, organize meetings and IRB post approval reporting.

www.cineca.it 17

Makerere SHS IRB Platform Demo

Enter a new study

www.cineca.it 18

Home page – Study registry

www.cineca.it 19

Enter a new study

Click here to enter a new study

www.cineca.it 20

Identification data of the study

At first it is necessary to enter data identification of the study: study code, title and type of the study. Once the form has been filled in, click on “Proceed” botton to save the data.

www.cineca.it 21

Home page of the study - Study details

Study summary information table: It helps to identify the study and is available in each form of the registry

The form Details of the proposed research contains informations about:-Performance site(s)-Collaborating Institutions-Funding-Details of study population - Proposed inclusione criteria

www.cineca.it 22

Details of the proposed research (1)

www.cineca.it 23

Details of the proposed research (2)

www.cineca.it 24Click Save to proceed with data entry

Details of the proposed research (3)

www.cineca.it 25

Study details – Research Team

Click on “Details of Research Team” to fill in this form

www.cineca.it 26

Click Save to continue

Details of Research Team

www.cineca.it 27

Study details - Documentation

Click on “Study documentation” to upload the documentation.

www.cineca.it 28

Study documentation – add a new document (1)

Choose the type of document you are uploading

www.cineca.it 29

Study documentation – add a new document (2)

Upload a file

www.cineca.it 30

Study documentation – List of documents included

It is possible to download, modify and delete documents

www.cineca.it 31

Send data to central database to check the documents by the IRB Secretariat (1)

Click here to send study data to the central database

www.cineca.it 32

Send data to central database to check the documents by the IRB Secretariat (2)

www.cineca.it 33

Check documentation for the next meetings by IRB

Secretariat

Makerere SHS IRB Platform Demo

www.cineca.it 34

Home Page – List of new studies to be checked

www.cineca.it 35

List of studies to be check by IRB Administrator

Click here to view study data alredy entered

www.cineca.it 36

Check study data – Access to study forms

www.cineca.it 37

Check study data – IRB Administrator review checklist

www.cineca.it 38

Click here to view or update the checklist

Check study data – IRB Administrator review checklist

www.cineca.it 39

IRB Administrator review checklist (1)

If data are complete, the system will show a new field at the bottom of the form, which ask to state the type of review

www.cineca.it 40

IRB Administrator review checklist (2)

www.cineca.it 41

When the IRB Administrator review is filled in and sent, it is possible to Schedule and prepare IRB meeting

www.cineca.it 42

Schedule and prepare IRB meeting by the Secretariat

Makerere SHS IRB Platform Demo

www.cineca.it 43

Home Page – Meeting calendar

Calendar of current month

Click here to “Add a New meeting” to enter a new meeting

Scheduled meeting to be prepared

www.cineca.it 44

Insert a new meeting

www.cineca.it 45

Home page of the IRB meeting

Data summary of the meeting

www.cineca.it 46

Select studies /amendments to be reviewed by IRB

Check from the lists new studies and suspended studies (major changes required), renewal reviewa and amendments.

It’s also possible to select a relator for each study

www.cineca.it 47

Home page of the IRB meeting

Click here to invite IRB members

www.cineca.it 48

IRB members invited (summon)

Tick members and investigators that should be invited to the meeting

www.cineca.it 49

Home page of IRB meeting

www.cineca.it 50

Planning agenda - Preview

The Agenda is partially pre-filled.

Is available on the platform a web editor that allow you to modify the agenda

www.cineca.it 51

Home page of the IRB meeting

Meeting agenda is ready and complete. To download it click on PDF icon

www.cineca.it 52

Home page of IRB meeting

Send summon and agenda to IRB members

www.cineca.it 53

Confirm the completeness of data

www.cineca.it 54

Prepare IRB minute after meeting (1)

Makerere SHS IRB Platform Demo

www.cineca.it 55

IRB meeting calendar

Click on the meeting to enter IRB opinion and prepare the minute

www.cineca.it 56

Click on Minute

www.cineca.it 57

Prepare minute of the meeting (1)

www.cineca.it 58

Prepare minute of the meeting (2)

www.cineca.it 59

Prepare minute of the meeting (3)

www.cineca.it 60

Prepare minute of the meeting (3)

www.cineca.it 61

IRB Decision

Makerere SHS IRB Platform Demo

www.cineca.it 62

IRB Decision (2)

www.cineca.it 63

IRB Decision (3)

www.cineca.it 64

IRB deliberation/decision form

www.cineca.it 65

IRB Decision (2)

www.cineca.it 66

Study Approval letter The study Approval letter will be available pre-filled and can be modify as a word document.

When the letter is complete, it is possible to save it and even print it in pdf format.

www.cineca.it 67

Complete IRB minute after meeting (2)

Makerere SHS IRB Platform Demo

www.cineca.it 68

Prepare minute of the meeting (3)

www.cineca.it 69

Prepare minute of the meeting (4)

It is possible to check the minute and use editor to modify the text

www.cineca.it 70

Here you can find the Minute of the meeting in PDF format

Prepare minute of the meeting (5)

www.cineca.it 71

Renewal of the study after IRB approval

Makerere SHS IRB Platform Demo

www.cineca.it 72

Home Page – Access to studies reviewed by IRB

www.cineca.it 73

List of approved studies

Choose the study, clicking on pencil icon

www.cineca.it 74

Renewal

www.cineca.it 75

Renewal

www.cineca.it 76

Renewal (1)

www.cineca.it 77

Renewal (2)

you can upload a file

you can upload a file

www.cineca.it 78

Renewal (3)

you can upload a file

www.cineca.it 79

Renewal

www.cineca.it 80

Renewal documentation (1)

you can upload a file

www.cineca.it 81

Renewal

Click here to send the renewal request. New forms will be dispayed after sending.

www.cineca.it 82

Renewal

www.cineca.it 83

Renewal – IRB Administrator review checklist (1)

www.cineca.it 84

Renewal – IRB Administrator review checklist (2)

www.cineca.it 85

Renewal

www.cineca.it 86

Renewal - Decision

www.cineca.it 87

Once the previous Renewal has been completed, a new Renewal section is

available

New Renewal

www.cineca.it 88

SAE and Amendments

SAE and AMENDMENTS sections

www.cineca.it 89

SAE - Serious adverse event reporting (1)

www.cineca.it 90

SAE - Serious adverse event reporting (2)

www.cineca.it 91

SAE - Serious adverse event reporting (3)

www.cineca.it 92

To add other SAE click on “Add a new form”

SAE - Serious adverse event reporting (4)

www.cineca.it 93

Amendments

In this section you can ask for amendments

www.cineca.it 94

Amendments - Request of a new amendment (1)

www.cineca.it 95

Amendments - Request of a new amendment (3)

www.cineca.it 96

Amendments - Request of a new amendment (3)

If you need to change information, click on “Study data”

www.cineca.it 97

Amendments - Update study data (2)

www.cineca.it 98

Amendments - Update study data (3)

Click on the pencil to modify data

www.cineca.it 99

Amendments - Update study data (4)

www.cineca.it 100

Amendments - Update study data (5)

An exclamation mark will be shown beside the forms that have been modified

At the and of revisions you can send data to central database for IRB amendment opinion

www.cineca.it 101

Amendments IRB Administrator Review (1)

www.cineca.it 102

if data are incomplete you can ask for an integration

Amendments IRB Administrator Review (2)

www.cineca.it 103

Amendments IRB Administrator Review (3)

if data are incomplete you can ask for an integration

www.cineca.it 104

Amendments – IRB opinion (1)

www.cineca.it 105

Amendments – IRB opinion (2)

www.cineca.it 106

Final Report

www.cineca.it 107

Final Report

www.cineca.it 108

Final Report