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: [email protected] 212-305-5883 [email protected] 212-851-7040
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