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Rascal IRB 2.0
Launch date: May 31, 2015
Alan Teller, Associate Director
Rachel Lally, Associate Director
IRB 2.0 Background
o Upgrade the investigator interface
Address 100+ requests (IRB/researcher/other)
o Obtain more complete applications – reduce returns
55% of all new protocols are returned at pre-review
66% of exempt and expedited protocols are returned at prereview
New protocol average times in: 2.1
(including external reviews, e.g. PRMC, JRSC, IBC)
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IRB 2.O Goals
Obtain more
complete applications
Streamline review
process and set up
for IRB 2.1 (IRB side)
Reduce turnaround time
without compromising
quality
Directed logic driven
questions with less
narrative text
Address researchers’
requests
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Features
New pages; consolidated topics
Specific pages for unique research components
Built-in “I don’t know” responses
Information to explain questions; hover text; revised help text
Options to indicate NHSR, exempt, expedited
Section to identify special circumstances
Funding, reliance, roles in MC trials, resources
Engaged personnel signoff revised
Earlier in process; PI only for renewals; attestation
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Prompts and Validations
Directed questions with required* responses
Many more required fields
Page and submit validations
• Individual pages cannot be saved until the required
information is provided
Submit validations
• Validations between pages will identify inconsistencies
and/or missing items prior to submission
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Stand-alone Protocols
Certain questions/sections designed to allow for referral to
protocols built outside of Rascal (e.g. sponsor’s protocols,
grants, multi-center or externally developed protocols)
The current “Study Description” is going away
– All related fields are incorporated into individual pages
– Accurate, detailed SD can be the stand-alone protocol
• Saved by Rascal upon submission
• Researcher can save if prepared but not submitted
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May 31, 2015 = “Go-Live” date
• Transition will occur overnight (into June 1st)
• NO extended Rascal shut-down
• Rascal upgrade, therefore cannot be phased
• Transition will occur by protocol as events* created/submitted
• One year for non-exempt studies
• Two years for exempt
• New fields cannot be filled out in advance
• New fields will be mapped to old, wherever possible
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All previously approved submissions will remain the same
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First submission after
May 31, 2015:
ALL new fields will be
required for ALL protocols,
renewals, mods (submissions
and resubmissions)
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Events in Researchers’ Queues
• Protocol/Renewal/Modification
• Status: Creating, Returned, Pending
• On the go live date (overnight):
• existing data in fields in the current submission that do not
map directly to fields in the new system will be cleared
• New fields will appear and require completion before
submission
• Protocol/Renewal/Mod created after May 31st - new fields
Applies regardless of how minor a modification may be or
whether or not a renewal involves changes
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Events in IRB Queues
• If returned by HRPO staff or the IRB, information in non-mapped fields
will be cleared upon return
• New fields will appear and completion will be required before resubmission
• If approved on/after May 31, without being returned
• New fields not required until a Renewal/Mod created
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Current Exempt Protocols
• Must be updated
• 5 year term (expanded from 2)
• Expect that some may get different determinations
Unanticipated Problems Reports and Closures
• New fields not required
• UPs – improved format
• Closures – additional questions
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Planning
Most new protocols in the current system are returned at least 1 time
55% of all new protocols are returned at pre-review
66% of exempt and expedited protocols are returned at pre-review
New protocol average times in: 2.1
WAIT TO CREATE & SUBMIT NEW PROTOCOLS
Advantage: will not need to convert the Protocol from IRB 1.0
format if the IRB returns the Protocol prior to approval or when
they create a Renewal or Modification
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HRPO Suggestions
New Protocols
Non-exempt Protocols that have a Pending or Returned status, status date within
the past 60 days = Resubmit now
Non-exempt Protocols that have a Pending or Returned status, status date > 60
days = Wait until IRB 2.0
Wait to create new Protocols until after June 1, 2015 so the Protocol will be in
the IRB 2.0 format
Modifications
Minor, straightforward, administrative, time sensitive= Submit now
Complex, not time sensitive = Wait until IRB 2.0
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HRPO Suggestions
Renewals
Check Committee Assignment & IRB Meeting Schedule
Expiration date before June 17 = submit now
Expiration date after June 17 = submit in IRB 2.0
Exempt Protocols and Renewals
Submit in IRB 2.0
Submitted and Approved after June 1 = 5 Year approval period
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Questions?
http://www.cumc.columbia.edu/dept/irb/contactus.html
[email protected]
212-305-5883
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