The document provides best practices and lessons learned for implementing Oracle Clinical and Remote Data Capture (RDC). It discusses establishing standards for training, standard operating procedures, work instructions, user roles and functions. It also covers developing an upgrade strategy and implementation plan that assesses risks and benefits. The intended audience includes those evaluating, setting up, or upgrading their Oracle Clinical/RDC system.

1. 4.6x Implementation Experiences
and Best Practices
November , 2012
Tammy Dutkin
Practice Lead, CDM and EDC
BioPharm Systems
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2. Tammy Dutkin
Practice Lead, CDM and RDC
• 20+ years of experience
in the clinical trials industry,
including 12 years of managing a
biometrics CRO
• 15+ years of experience with
Oracle Clinical and Remote Data
Capture (RDC)
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3. Today’s Agenda
• Welcome and Introductions
• Who, What and Why?
• Common Themes
• Best Practice Considerations
– Training
– Standards
– SOPs and WINs
– User Roles and Functions
– Upgrade / Patching Plan
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4. 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
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5. What is 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
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6. Why are Standards Important?
 In order to capitalize on the functionality within OC/RDC, standards
are critical
 Standardization helps minimize study setup time - reusability of
standard objects, processes, etc.
 Increase in efficiency
 Increase in quality
 Increase in productivity
 Decrease in time and money
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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
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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!
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9. Training Best Practices
 Process and system training is needed
 Formalize and customize the training
- Role based training
- Consistent written material
 Use a variety of delivery methods
- Instructor-led (onsite vs public)
- Online web-based
- Hands-on exercises
- Internal „train the trainer‟
 “Just-in-Time” training
– Not too early
– Plan „play‟/practice time in training environment
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10. Training Best Practices
 Pilot study(ies)
– What study(ies) to use
– Helps in making decisions and planning standard processes
 Self education …
– LOTs of resources available
 Have realistic expectations from training
 Once training is complete, who can you go to with questions /
“hand-holding”
 Learn from your mistakes (you WILL make some!)
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11. Other Training Considerations
 Cross-functional education & understanding
- The “whats” and “whys”
 Ongoing
 Retraining
 Certification / proof of training
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12. Standards, Standards, Standards
• 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
• Maintenance of standards
– CRFs, OC objects, DMP, SOPs, WINs, training materials, processes, other
resources/tools
– Everyone‟s responsibility
• Process Improvement
– Openness to change
– “Think outside the box”
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13. Standard Operating Procedures
 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.
 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
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14. Standard Operating Procedures (cont.)
• Review and assess current SOPs and business processes
– Identify gaps and requirements gathering
• Consider other departments
– Overlaps? … gaps? … inconsistencies?
• SOPs are subject to audit
– Any other documents/templates etc. referenced in the SOPs are
also subject to audit
• Ideal: finalize before “go live”
– Reality: not quite ready
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15. Standard Operating Procedures Needed
• Recommended: 6-12 SOPs for OC/RDC
SOP Description
Global Library Creation/activation of new objects,
maintenance, Copy Group, GLIB standards
Security Roles, access privileges, account maintenance
Study Definition Study Plan / Design, DCMs, DCIs, DCI Book,
Extract view definitions, Testing/UAT,
Procedures
Study Conduct Data Entry, Discrepancy Management, DCFs,
Data loading, Lab Normal Maintenance.
Review/Approval
Study Lock Lock, Freeze, Privileged update, Un-freeze,
archiving study documentation
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16. Work Instructions (WINs)
 Work Instructions provide detailed steps on how to perform a specific
task or function in OC/RDC
 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
• 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?
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17. Work Instructions (cont.)
• 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
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18. Work Instructions (cont)
• Each SOP should have at least one supplemental WIN
(generally 1-7 WINs per SOP)
• Can reference templates and standards
• As long as the WINs are not referenced in your SOPs, they
are not auditable
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19. 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
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20. Upgrade Strategy
• Have a long term strategy when it comes to upgrading your technology
platform
• As patches / new versions are released assess risk/benefits of
implementation
– All parties impacted should assess risk and benefits
• The right level of inclusion
• Buy in from all parties
• Active participation in the process
• Recognize contributions and needs of ALL members
– Be well informed. Use your resources!
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21. Identifying Risks
What areas will be impacted by the upgrade?
– Regulatory impact (what regression testing is needed?)
– SOPs / WINs / Guidelines
– Standards / Templates
– Training
– Security
Other Considerations:
– Current workflow (will downtime impact current project timelines?)
– Current resource allocation
– Cost of doing business
– System integration (will this affect other systems that are integrated
with your database?)
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22. Assessing Risk
Assess risk on multiple levels
• Impact to business: How critical is the implementation to ensuring ease
of business use or data integrity
• Likelihood or frequency of use: What is the frequency of use for the
system/patch being applied
• Detectability: Will any failure in the system be detected easily
Determine the gaps!
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23. Assess Benefits
What are the benefits to applying patches / version
upgrades?
– Process improvements / enhancements
– Bug fixes
– Efficiencies
– Security
– Regulatory compliance
– Sell-ability
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24. Implementation/Change Plan
Project Plan should include:
– Phases/Tasks
• Planning Phase
• Testing Phase
• Production Cutover
• Process Re-engineering
• Training
• Pilot
– Resource allocation
– Timelines
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25. 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
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26. Contact Us
• North America Sales Contact:
Rod Roderick
rroderick@biopharm.com
+1 877 654 0033
• Europe/Middle East/Africa Sales Contact:
Rudolf Coetzee
rcoetzee@biopharm.com
+44 (0) 1865 910200
• General Inquiries:
info@biopharm.com
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