This document summarizes an agenda for a presentation on Oracle Clinical / Remote Data Capture Implementation Standards and Best Practices. The presentation covers who the intended audience is, defines what best practices are, explains why standards are important, discusses common themes around teamwork, standards, process improvement and training. It also outlines topics on user roles and functions, standard operating procedures, work instructions, and implementation and usage standards. The goal is to provide guidance on best practices for implementing Oracle Clinical and Remote Data Capture to increase efficiency, quality and productivity.

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)