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 Dutkin

Practice Lead, CDM and EDC

BioPharm Systems


Today’s Agenda

• Welcome and Introductions

• Who?

• What?

• When?

• Why?

• Managing expectations

• Some examples


Tammy Dutkin

Vice President, CDM and RDC

• 20+ years of experience

in the clinical trials industry,

including 12 years of managing a

biometrics CRO and 2 years

managing a full service CRO

• 15+ years of experience with

Oracle Clinical and Remote Data

Capture (RDC)


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 other

capabilities a solution offers. This lack of knowledge could lead to

misunderstandings, communication problems, and misaligned

expectations among team members.


Who’s 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!


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


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 abbreviated exercises – Overview

– Concepts

– Data Entry

– Discrepancy Management

– Verification

– Approval

– Special Listings

– Reports

(incorporating company’s workflow and showing all role perspectives, give the 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 during

someone’s 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 don’t see the benefits of having the training, they won’t get

anything out of it.

• If they don’t apply what they’ve learned immediately following the

training, 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 function’s “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 being checked can have major impacts on data entry

– Example: when a question is marked as an indicator question, you won’t be able to unmark it once the DCM is activated

• What can be changed at the GLIB and Study Definition level after things have been activated

– Examples: you can increase a question length, but not decrease it; you can’t change the question type (Char, Non-Lab etc) once the question is activated; you need to check 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 they aren’t working

– Example: if a validation has two question groups associated with it and you don’t check “create placeholder”, the check won’t run if both question groups haven’t been entered.



• 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 don’t 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 where

exception 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 all sites from the Discrepancy Database – Especially helpful when CRAs are trying to figure out the overall

volume 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 – Don’t have to wait for those checks to run after they’ve 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 other

when 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.


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

up in RDC...


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?”


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 overall

process

• Be able to identify ways to streamline

• Be able to communicate more effectively


Q&A


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


– +1 877 654 0033

• Europe/Middle East/Africa Sales Contact:

– Rudolf Coetzee, Director of Business Development


– +44 (0) 1865 910200

• General Inquiries:


2013 ohsug - oracle clinical and rdc training for data management and clinical teams

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