Transcript Improving Protocol Review and Approval Efficiency

Improving the Efficiency
of Protocol Reviews and
Approvals
Alison D. Pohl, MS, rLATg, CPIA
Research Compliance Monitor / IACUC Administrator
University of Connecticut Health Center
Farmington, CT
What is “improving” protocol review?
 From the PI’s perspective:
 Only one review (e.g., no “back and forth”
revisions)
 Focus on the “important stuff”, not the small
details
 Make it as easy on me as possible
 From the IACUC’s perspective:
 Catch everything that is important (one review
may not be enough)
 Make it as easy as possible for the IACUC
 Try to make it as easy as possible for the PI
What is “improving” approval efficiency?
 From the PI’s perspective:
 Get my approval as fast as possible (preferably
yesterday)
 From the IACUC’s perspective:
 Get the approval done as fast as possible (though
yesterday is probably not possible)
Seems like there is a shared goal here??
What can the PI do to improve
the efficiency of a review?
 Submit a thoughtful and complete protocol that tells the
whole story
 Make sure all questions are answered
 Make sure the answers to the questions are actually answers
to the questions; in other words, don’t answer the question
with incomplete or incorrect information
 Submit protocols by established deadlines
 Submit protocols for a pre-review if that activity is performed
by an institution
 When submitting revisions after IACUC review
 Make sure all comments are addressed
What can the IACUC do to improve the
efficiency of a review?
 Perform pre-reviews
 Can be done by the IACUC administrator to a great degree
 Veterinary pre-review can be very important
 Ensure IACUC members know what constitutes an appropriate
review
 Reviews should be consistent between protocols and IACUC members
 Training, training, training!
 Have the IACUC invested in the research of the institution
 Complete reviews by an assigned deadline
 Do your review as if you were the PI (be kind)
 Utilize DMR when you can
 One way to improve efficiency is….
Go Electronic
 Can help you make the whole protocol review and
approval process faster, more thorough, and more
consistent
 Does not mean just using an electronic protocol
development and review system (either commercial or
home-grown)
 Electronic methodologies can mean more version
control, less chance of losing vital information, and
increased access to information for both the PI and the
IACUC
 And you have the added benefit of “being green”
Non-system electronic methods
 Shared electronic drives (through your IT department)
 All IACUC members can access all information
 Information access is restricted to those members who
have been “allowed” access
 Typically backed up by the Institution so that data loss is
unlikely
 Electronic signatures (e.g., use of Adobe Acrobat)
 Takes less time because you do not have to physically go to
someone’s office for a signature
 Accepted by most agencies (OLAW, USDA, NIH, etc.)
 Web-based sign up services (e.g., Signupgenius.com)
 Can be used for facility inspections and meetings
Non-system electronic methods
 Programs for facility inspections (e.g., InvisoSystems)
 There are programs out there that you can use with an iPad
or smart phone to document real-time documentation of
facility and laboratory inspections
 They can allow for the automatic compilations of
deficiencies into a report that can be emailed to the
appropriate responsible individuals
 Programs for documenting review changes (e.g.,
SharePoint, PleaseReview)
 Though use of a shared drive can also get people to see the
same documents, typically only one person can make
changes at a time
 There are programs which can automatically track changes
which, at the end of the review period, can incorporate
the changes into a nicely formatted document
Electronic protocol development
and review systems
 Can be commercial or home-grown
 Advantages
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Complete historical record of the submissions/reviews
PI can see where in the process his submission is
Version control
Electronic signatures
Auto-population of demographic information
Pull down menus with appropriate answers
Templates for common procedures
Electronic protocol development
and review systems
 Disadvantages
 Change- and this can be a significant problem depending on
your institution
 More technical process that typically requires more training
for everyone involved
 More structure and less flexibility
 More complex
 Periodic upgrades can create lost data
 Administration is typically more labor intensive (translation:
MORE WORK FOR THE ADMINISTRATOR)
 If your system is web-based, and you lose web access, all
work can be lost permanently
 Cost- system, maintenance, license(s), etc.
If you decide to go with an electronic
system:
 BE PREPARED. It is often a case of two steps forward,
one step back
 Establish a selection committee composed of IACUC
administrator, member, PIs, safety, IT, etc. to represent
various end users
 Get references from current users. This can be difficult
if your institution has strict criteria for references
 Do not under-estimate the need for training by IACUC
administrators, IACUC reviewers, and PIs
What we learned when implementing a
commercial system:
 Need a strong relationship with your vendor
 Need a champion in senior management of your institution
 Listen to your vendor’s recommendations, but realize that what they
might be telling you might not be fully accurate (positive spin)
 Negotiate your contract CAREFULLY
 Patience really IS a virtue; glitches will happen and the process will
take longer than you think
 Expect lack of participation from key stakeholders
 Lack of depth needs to be avoided
 Resistance from end-users should be expected
 Again, training is key for success
Acknowledgements
I would like to gratefully acknowledge the following
individuals for their help and expertise:
Marcy Brown, MA, CPIA
Regulatory Compliance
Pfizer, Worldwide Research & Development
Stacy Pritt, DVM, MBA, CPIA, DACAW
Director, IACUC
UT Southwestern Medical Center