2013 ohsug - oracle clinical and rdc training for data management and clinical teams
TRANSCRIPT
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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
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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)
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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 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
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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 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
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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 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.
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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 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
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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 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!
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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 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
+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: