1. Oracle Clinical / Remote Data
Capture Implementation Standards
and Best Practices
Lori Venable
Thank you for joining. We will begin shortly.

2. Welcome & Introduction
Lori Venable
Principal Consultant
• 23+ years of experience
in the clinical trials industry
• 15+ years of experience with
Oracle Clinical and Remote Data
Capture (RDC)

3. Today’s Agenda
Time Topic
10:00-10:05 Welcome and Introduction
10:05-10:10 Who, What and Why?
10:10-10:20 Common Themes
10:20-10:25 Training
10:25-10:30 User Roles and Functions
10:30-10:35 SOPs and WINs
10:35-10:45 Implementation and Usage Standards
10:45-11:00 Q&A

4. Who, What and Why?
• Who is the intended audience?
– Non-OC/RDC Users evaluating the
application
– New users of OC/RDC who are defining
their implementation standards, SOPs,
WINs, etc.
– Current OC/RDC Users contemplating an
upgrade to newer version and/or
modifications to existing practices

5. • What is a Best Practice?
 A method, process, activity, incentive, or reward that is believed
to be more effective at delivering a particular outcome than any
other technique, method, process, etc. when applied to a
particular condition or circumstance.
en.wikipedia.org/wiki/Best_practice
 A way or method of accomplishing a business function or process
that is considered to be superior to all other known methods.
www.qaproject.org/methods/resglossary
 A best practice is a business process with demonstrated ability
to achieve superior results. Best practices represent proven
methodologies for consistently and effectively achieving a
business objective.
www.hrsdc.gc.ca/eng/workplaceskills/oles/2009/glossary
Who, What and Why?

6. Who, What and Why?
• Why are standards important?
– In order to really capitalize on the
functionality within OC/RDC, standards
are critical
– Standardization helps minimize study
setup time immensely – reusability of
standard objects, processes, etc.
– Increase in efficiency
– Increase in quality
– Increase in productivity
– Decrease in time and money

7. Common Themes …
• Teamwork
– Right level of inclusion
– Cross-functional partnership
– Recognize contributions and needs of ALL
members
– Communication
– Buy-in from all team members
– Active participation
– Are there global needs?
– Benefits for proper level of team
involvement are phenomenal

8. Common Themes
• Standards … standards … standards
– Increase ease and speed of use for OC/RDC
– Increase efficiency and productivity
• Process Improvement
– Continuous
– Debriefing after all projects
– Receptivity
– DON’T BE AFRAID to change!
• Use your resources!

9. Training …
• Application(s) … OC / RDC
– Formal training … e.g., BioPharm
– Right level of ‘inclusion’
– Hands-on users vs one-off users vs mgmt
– Delivery method
– Instructor-led (onsite vs public)
– Online web-based
– Hands-on exercises
– Internal ‘train the trainer’
– Consistent material
… cont…

10. Training …
• Application(s) … (cont…)
– “Just-in-Time” training
– Not too early
– Plan ‘play’/practice time in training environment
– Pilot study(ies)
– What study(ies) to use
– Helps in making decisions and planning standard
processes
– Self education …
– LOTs of resources available
– Learn from your mistakes (you WILL make
some!)

11. • Processes
– Assess current processes and future needs
– Formal and informal
– Internal and/or external (e.g, BioPharm)
– SOPs / WINs
– Process Improvements
Training …

12. • Other training considerations
– Cross-functional education & understanding
– The “whats” and “whys”
– Ongoing
– Retraining
– Certification / proof of training
Training

13. User Roles and Functions
• Clearly outline all needed roles/
functions
• Current resource availability
• Company size
• Internal vs external resources
• User account creation and
maintenance
– Pre-requisites
• Other considerations
– Frequency of some tasks

14. Standard Operating Procedures…
Best Practices:
 SOPs should be very high-level, with minimal
detail – the overview of “WHAT” we do
 Begin to draft SOPs during the training and
pilot(s)
 Right level of inclusion
 Train users on the SOPs as part as part of
system training
 Recommended: 6-12 SOPs for OC/RDC
SOPs associated with OC/RDC typically include information
about the setup and use of the application(s) in conjunction with
the day-to-day collection and management of clinical trial data.

15. • Review and assess current SOPs and
business processes
– Identify gaps and requirements gathering
• Consider other departments
– Overlaps? … gaps? … inconsistencies?
• SOPs are subject to audit
– Do not reference other documents in SOPs
• Ideal: finalize before “go live”
– Reality: not quite ready
– Document … document … document
SOPs

16. Work Instructions (WINs) …
Best Practices:
 WINs should be more detailed … the “HOW” we
do it
 Develop WINs concurrently with SOPs
 Right level of inclusion
 Train users on the WINs as part as part of
system training
 Each SOP should have at least one supplemental
WIN (generally 1-7 WINs per SOP)
Work Instructions provide detailed steps on how to
perform a specific task or function in OC/RDC

17. • Supplement the SOPs with the
detailed step-by-step “HOW TO”
• Supplement to training
• Review and assess current processes
– Identify gaps and requirements gathering
• Consider other departments
– Overlaps? … gaps? … inconsistencies?
WINs …

18. • WINs are not subject to audit
– Freely reference other documents/sources
• Attachments common
– Checklists, quick reference guides, etc.
• Less formal than SOPs
– Still need inclusion, review, finalization, etc
– Easier to update/modify
• Ideal: finalize before “go live”
– Reality: still in development
WINs

19. • OC / RDC implementation is most
successful with strong commitment to
standards
• 80/20 rule
– Protocols, CRFs, edit checks, cross-study
consistencies, etc.
– OC/RDC implementation standards
• But … recognize need for flexibility
– Communicate the “costs” of deviations from
standards
– May need to challenge some requests
Implementation and Usage
Standards …

20. • Maintenance of standards
– CRFs, OC objects, DMP, SOPs, WINs, training
materials, processes, other resources/tools
– Everyone’s responsibility
• Process Improvement (again! )
– Openness to change
– “Think outside the box”
Implementation and Usage
Standards

21. Summary
• Keep in mind our common themes:
– It’s all a team effort
– Communication
– Standards … standards … standards
– Process Improvement … ongoing, continuous
– Don’t be afraid to make mistakes … be open
to learning from them
– Take advantage of all the resources you have
at your disposal

22. Q&A

23. Closing
Thank you for attending!
This webinar will be posted on
www.biopharm.com
within 24 hours
Contact BioPharm Systems
United States: +1 877 654 0033
EMEA: +44 (0) 1865 910200
Email Address: info@biopharm.com
(also Vicky Green: vgreen@biopharm.com)