Preparing for Rascal IRB 2.0 Roll-out

Preparing for Rascal IRB 2.0 Roll-out
Goals of IRB 2.0
Features
The Transition
Planning - HRPO Suggestions
Events in Researchers’ Queues (i.e., status of Creating, Returned, Pending)
Events in IRB Queues (i.e., status of Submitted, Distributed, Assigned to Meeting)
Events not yet Created
Currently “Approved" Exempt Protocols
New Protocols not yet created
New Protocols with a Pending or Returned status
New Modifications
New Renewals
Release of the enhanced IRB/Human Subjects module (IRB 2.0) will take place on May 31, 2015.
On and after June 1, 2015, the system will not allow submission or resubmission of a new Protocol,
Renewal or Modification without a substantial number of new fields being completed.
Human Research Protection Office (HRPO) staff will make every effort to process new Protocols,
Renewals and Modifications (i.e., Rascal Events) that have been submitted to date, to provide the
opportunity for approval without having to convert the Event to the IRB 2.0 format.
Goals of IRB 2.0
Reduce turnaround time without compromising quality
 Upgrade the investigator interface
Address 100+ requests for Rascal improvements (IRB/researcher/other)
 Obtain more complete applications – reduce returns
o 55% of all new protocols are returned at pre-review
o 66% of exempt and expedited protocols are returned at pre-review
o All new protocols average 2.1 submissions prior to approval (including external reviews, e.g.
PRMC, JRSC, IBC)
 Reduce narrative text fields, which are time-consuming for researchers to prepare and may not
provide the information that the IRBs need to make regulatory determinations
 Enhance IRB ability to meet regulatory requirements, e.g., by asking targeted questions that solicit
information to support federally-defined approval criteria and institutional requirements
 Facilitate ability to run more reports (for researchers, HRPO/IRBs, institutional officials)
o Researcher examples:
 For a specific department, all clinical trials involving a medical device for which
children are included among participants;


For a single Principal Investigator, studies conducted internationally, involving nonEnglish speaking participants and for which a waiver of informed consent has been
approved.
Streamline review process and set up for IRB 2.1 (i.e., improvements to the administrative IRBreview side, such as routing protocols, IRB meeting agendas and minutes, approval letters, stamping
of approved documents)
Features
 New pages; consolidated requests (e.g., all requests for Subject information is on one page)
o Specific pages for unique research components
 Built-in “I don’t know” responses, e.g., for “IRB of record” field
 Extensive explanatory information to provide the basis for questions and expectations for answers
o Information to explain questions; hover text; revised help text (i.e., all Help text fields are
complete, with relevant information)
 Options to indicate that the protocol may be “Not Human Subjects Research”, or eligible for
exemption or expedited review
 Attributes Section to identify special circumstances
o Funding, reliance, roles in MC trials, resources
 Engaged personnel signoff requirements revised
o New Protocol, first time in: All engaged personnel (e.g., investigators, coordinators) must
approve and complete protocol-specific conflict of interest (COI) disclosure; anyone listed in
the Personnel section may submit
o New Protocol resubmissions: PI must approve and complete COI form; anyone listed in the
Personnel section may submit
o Renewals and Modifications, first time in and resubmissions: PI must approve and complete
COI form; anyone listed in the Personnel section may submit
o Unanticipated Problem (UP) reports: No signoff necessary; anyone listed in the Personnel
section may submit
o Closure requests: No signoff necessary; anyone listed in the Personnel section may submit
 Signoff process revised
o Can occur earlier in the process of creating a Protocol
o Only the General, Personnel and Funding pages must be completed and saved
o Approval by engaged personnel includes attestation (i.e., awareness that individual is
named on the protocol, acknowledgement of responsibility to comply with protocol as
approved by the IRB and to submit revised annual COI form if financial interests with respect
to protocol change) in addition to a protocol specific COI signoff
 Prompts and Validations
o Format of module = directed questions with required responses
• Each required question is identified by a red asterisk (*)
• There are many more required fields which facilitates the ability of the system to
compare responses
o
•
Page validations
• Individual pages cannot be saved until the required information is provided
o Submit validations
• Validations between pages will identify inconsistencies and/or missing items prior to
submission
Reliance on Stand-alone Protocol
o Some questions/sections are designed to allow for referral to protocols built outside of
Rascal (e.g. sponsor’s protocols, grants, multi-center or externally developed protocols)
• For these questions, the response options include a checkbox to indicate that the
requested information can be found in the stand-alone protocol
o The current “Study Description” is going away
• All related fields are incorporated into individual pages
• Tip: An accurate, detailed SD can be the stand-alone protocol
• Prior to first time submission of an Event in IRB 2.0, a researcher can save the
Study Description that is prepared in Rascal IRB 1.0 as a pdf document and
attach it with Stand-alone Protocol as the Document Identifier
• Note: Study Descriptions that were drafted as part of a new protocol in Rascal
IRB 1.0 but never submitted will be cleared as part of the roll over on May 31st.
The content of the Study Description field in IRB 1.0 should be saved as a
separate document outside of Rascal prior to the roll out – that document may
still be attached as a Stand-alone Protocol.
The Transition
May 31, 2015 = “Go-Live” date
• Transition will occur overnight (into June 1st)
• NO extended Rascal shut-down
• This is an upgrade from one platform to another within Rascal, therefore the transition cannot
be phased by school, department or any other factor
• Transition will occur by protocol as Events are created and/or submitted
• It will take approximately one year to transition all non-exempt studies
• The transition period will be approximately two years for exempt studies
• New fields cannot be filled out in advance
• New fields will be mapped to old, wherever possible – the number of mapped fields is limited
• For all resubmissions, and new Renewals and Modifications, this will bring forward data
that has previously been entered
• Because of change in format and type of questions, there are many new fields that
cannot be mapped to an old field
All previously approved submissions will remain the same
These are hyperlinks to pdf files for
previous submissions, to allow easy
access for researchers, HRPO staff,
and IRB members
Reminder! In the first submission or re-submission after May 31, 2015:
ALL new fields will be required for ALL protocols, renewals, modifications
Planning - HRPO Suggestions
Events in Researchers’ Queues (i.e., status of Creating, Returned, Pending)
• Protocol/Renewal/Modification
• 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
• This applies regardless of how minor a modification may be or whether or not
a renewal involves changes.
Events in IRB Queues (i.e., status of Submitted, Distributed, Assigned to Meeting)
• 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 re-submission
• If approved on/after May 31, without being returned
• New fields not required until a Renewal/Mod created
Events not yet Created
• Protocol/Renewal/Mod created after May 31st - new fields
• Unanticipated Problems Reports and Closures
• New fields not required
• UPs – improved format
• Closures – Subjects page must be completed
Currently “Approved" Exempt Protocols
• Must be updated when a Renewal or Modification is created - new fields required
• 5 year “approval” period for protocols/renewals submitted or resubmitted on or after June 1,
2015 (expanded from 2)
• Expect that some may get different determinations
New Protocols not yet created
 Because most new Protocols are returned at least one time: wait to create & submit new
protocols until on or after June 1, 2015
 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
 Exempt protocols submitted and approved after June 1 = 5 Year approval period
New Protocols with a Pending or Returned status
 Non-exempt Protocols with status date within the past 60 days = Resubmit now
o If the Return status is the outcome of a convened IRB meeting = Wait until IRB 2.0
 Non-exempt Protocols with status date > 60 days = Wait until IRB 2.0
New Modifications
 Minor, straightforward, administrative, time sensitive= Submit now (i.e., on/before May 22)
 Complex, not time sensitive = Wait until IRB 2.0
New Renewals
Check Committee Assignment & IRB Meeting Schedule
 Expiration date before June 17 = submit now
 Expiration date after June 17 = create and submit in IRB 2.0
Exempt renewals: wait to create & submit until on or after June 1, 2015 - approved after June 1
= 5 Year approval period
Contact the IRB office if you have questions:
irboffice@columbia.edu
212-305-5883
askirb@columbia.edu
212-851-7040