This document outlines a training presentation for clinical and data management teams on Oracle Clinical and Remote Data Capture. The presentation covers an introduction to the topic, who should be involved in training, what topics the training should cover for both Oracle Clinical and Remote Data Capture, when the training should take place, why cross-training is important, tips for a successful training, and examples of topics that could be eye-opening for data managers and clinical research associates. The goal is to provide participants with a better understanding of the full capabilities of the systems beyond just their own roles in order to improve communication and collaboration.

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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

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Today’s 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 a
biometrics CRO and 2 years
managing a full service CRO
• 15+ years of experience with
Oracle Clinical and Remote Data
Capture (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 other
capabilities a solution offers. This lack of knowledge could lead to
misunderstandings, communication problems, and misaligned
expectations among team members.

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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!

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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

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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)

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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

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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

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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

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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!

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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

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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.

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Some “eye-opening” topics for Data Managers
• 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

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Some “eye-opening” topics for Data Managers
• 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

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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!

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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.

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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 overall
process
• 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
– rroderick@biopharm.com
– +1 877 654 0033
– Vicky Green, VP of Sales, Data Management Solutions
– vgreen@biopharm.com
– +1 877 654 0033
• Europe/Middle East/Africa Sales Contact:
– Rudolf Coetzee, Director of Business Development
– rcoetzee@biopharm.com
– +44 (0) 1865 910200
• General Inquiries:
– info@biopharm.com