2013 OHSUG - Oracle Clinical and RDC Training for Data Management and Clinical Teams

7/27/2019 2013 OHSUG - Oracle Clinical and RDC Training for Data Management and Clinical Teams

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Oracle Clinical and Remote Data

Capture Training for Data

Management and Clinical Teams

September 22, 2013

Tammy DutkinPractice Lead, CDM and EDC

BioPharm Systems


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Todays Agenda

Welcome and Introductions

Who?

What?

When?

Why?

Managing expectations Some examples


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Tammy Dutkin

Vice President, CDM and RDC

20+ years of experience

in the clinical trials industry,

including 12 years of managing abiometrics CRO and 2 years

managing a full service CRO

15+ years of experience with

Oracle Clinical and Remote DataCapture (RDC)


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Introduction

Since data management and clinical teams are often taught how to

use systems specifically for the tasks and roles they are assigned, it is

not uncommon for system users to be unaware of the many othercapabilities a solution offers. This lack of knowledge could lead to

misunderstandings, communication problems, and misaligned

expectations among team members.


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Whos involved?

Everyone needs to buy in that technical cross training is important

enough to dedicate the time and the resources (Managers,

Trainers, the people being trained) The trainees should have a basic understanding of the big picture

and an in depth of understanding of their role/job function

Know the level of the trainees non-technical-ness and understand

that the training might not be ideal for everyone!


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Who gives the training?

The person conducting the training should understand the

perspective of who is being trained as well as the material they are

training on this can be difficult to resource! There are pros and cons of having the person be internal to your

organization


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What should they be trained on for Oracle Clinical?

Abbreviated OC Basics (3-4 days) including abbreviated exercises,focused more on functions/process than technical aspects Overview

Common Functions Study Design

CRF Modeling

GLIB

Simple DCMs / DCIs

Complex Modeling

Data Entry Data Managers should know this already Procedures

Discrepancy Management Data Managers should know this already

DCFs (if this is used by the company, Data Managers should know this already)

Data Lock / Freeze

RDC Setup (demo only) Flex studies, graphic layouts, DCI Blinding,

Conditional Branching



What should everyone train on for RDC?

RDC Onsite Basics (2 days) including abbreviatedexercises

Overview Concepts

Data Entry

Discrepancy Management

Verification

Approval

Special Listings

Reports

(incorporating companys workflow and showing all role perspectives, givethe users a chance to play in the system using the different roles)



When?

Neither OC technical or RDC training would be good to give

someone who is new to the industry

OC Technical training is not the right training to be given duringsomeones first week on the job

Should be real time (so they are able to apply immediately following

training)

Needs to be during a time the trainer/trainees are free from

distractions



Why?

Gain insight / perspective

By learning the systems capabilities, they can identify ways

to simplify their own job

Avoid communication issues if everyone is speaking the

same OC language



Some warnings..

If they dont see the benefits of having the training, they wont get

anything out of it.

If they dont apply what theyve learned immediately following thetraining, they will forget the majority of it.

By the second day of training, several people in the class will have that

deer in the headlights look

At least one person after having the training, will be crazy enough to

decide they want to switch to the database design team



So, manage the expectations!

The objective is not for your DMs and CRAs to walk out of the training

and be able to set up a database.

The objective is: To have a deeper understanding of the systems capabilities and limitations

To have a new perspective on what it takes to setup a study

Have a whole new set of acronyms they can impress their friends with

Be able to think outside their functions box and streamline their own

processes And have a clearer vision of the big picture!



Some tips to a successful class

Make sure the expectations and objective of the class is clear and

communicated to everyone well before the class is scheduled

Encourage the trainees to bring in their questions Make it interactive

Provide a training environment to play in and make sure everyone is

able to access it

Insist EVERYONE does the exercises

Keeping coming back to the big picture and stressing how things tie

together. That lightbulb will go on eventually!

Keep the groups small and similar in level of experience

Provide food and lots of caffeine



Some eye-opening topics for Data Managers

Basics of how global objects are created and how one little box beingchecked can have major impacts on data entry Example: when a question is marked as an indicator question, you wont be able to

unmark it once the DCM is activated

What can be changed at the GLIB and Study Definition level afterthings have been activated Examples: you can increase a question length, but not decrease it; you cant change

the question type (Char, Non-Lab etc) once the question is activated; you need tocheck that a question is DVG modifiable, but you can change that DVG at the study

level

How validations are programmed and how to trouble shoot when theyarent working Example: if a validation has two question groups associated with it and you dont

check create placeholder, the check wont run if both question groups havent beenentered.




How conditional branching / flex studies can cut down on the number of

edit checks that are needed

Example: By making the Pregnancy Test questions only appear for Female subjects,an edit check confirming males dont have a positive pregnancy test is not needed

Alpha DVGs uses and cautions

Example: An alpha DVG can be used to allow the word UNKNOWN for a Date

question, however that value will be stored in the Exception Value Text. That

Exception Value Text needs to be pulled in the extract as the Value Text will be

blank. Throughout the study, DM needs to be checking for instances whereexception value texts are needed.

Using announcements and attachments in RDC

Make sure everyone is working off the same version of documents and has access

to the information they need




Down and dirty data viewing/querying from the View Definitions screen

Easy way to get a simple listing

What RDC looks like / functions for other users Will help them phrase queries appropriately for the site and be able to support the

other users

The ability to attach eCRF guidelines to an individual eCRF

The extra work of setting this up ahead of time can save dozens of questions and

hundreds of queries from your sites. Ensures everyone is referencing the same

guidelines.

Using special listings for cross checks

By cutting and pasting the special listings for AEs/ConMeds/MH into Excel, easy

way to do manual cross checks between the 3 modules



And for CRAs

Being able to view/action multiple discrepancies across allsites from the Discrepancy Database

Especially helpful when CRAs are trying to figure out the overallvolume of work they need to get done

What their sites/Inv see when they log into RDC Help them to be able to help their sites

Using Special Listings Same as Data Managers. Can be used to run cross checks across

modules

Running the offline edit checks Dont have to wait for those checks to run after theyve already left

the site. Run them now!



And for CRAs

Differences between univariate and multivariate

discrepancies.

Why do some queries fire when sites tab through the field and otherwhen they hit save?

Why/how discrepancies close Understanding that edit checks that fired during batch validation are only

going to close when batch validation runs again

How conditional branching / flex studies can cut down on

the data entry and SDV

No longer the need to mark pages blank for screen failures or early

withdrawal or for different groups of subjects.


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By training, you can avoid the DM giving the DB Programmer this form to set

up in RDC...


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Or can avoid requests/questions from the study manager such as...

Just create one query that covers all the subjects...

Why is this query not firing/not closing when my site saves

the form?

Why can we not approve/verify this page?

Where can I run a listing/report?


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Summary

By training your data management and clinical teams on the many

other capabilities OC/RDC offers, the entire team will benefit

Have greater insight / perspective and a clearer picture of the overallprocess

Be able to identify ways to streamline

Be able to communicate more effectively


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Q&A


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Contact Us

North America Sales Contacts:

Rod Roderick, VP of Sales, Trial Management Solutions

[email protected]

+1 877 654 0033

Vicky Green, VP of Sales, Data Management Solutions

[email protected]

+1 877 654 0033

Europe/Middle East/Africa Sales Contact:

Rudolf Coetzee, Director of Business Development

[email protected]

+44 (0) 1865 910200

General Inquiries:

[email protected]

Date post:	14-Apr-2018
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2013 OHSUG - Oracle Clinical and RDC Training for Data Management and Clinical Teams

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