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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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 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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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
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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 companys 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 someones 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 dont see the benefits of having the training, they wont get anything out of it. If they dont apply what theyve 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 functions 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 wont 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 cant 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 arent 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 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 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 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

Dont have to wait for those checks to run after theyve 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
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