Phase 2 of the eIRB data migration has begun, and nearly all pre-existing (paper) IRB protocols have now been transferred into the eIRB system. HUD, Emergency Use, Single/Compassionate Use, NCI CIRB and exempt protocols have not been transferred, and there are a handful of other protocols that will be transferred into the eIRB system by mid-week (some protocols expiring in June 2012 or later).
Updated protocol approval and expiry dates have also been transferred into eIRB for protocols that were migrated in Phase 1, but not converted (protocols that went through continuing review on paper during the grace period).
Principal investigators or an administrative contact are required to convert the existing paper protocol to an electronic protocol in eIRB at time of continuing review. Until that time, amendments, safety or other reporting and study closure notifications can be submitted using paper forms (study closure can also be done in eIRB via the Final Report form). Once a protocol has been converted to an electronic protocol at time of continuing review, all subsequent submissions for that protocol must be in eIRB.
Because of considerable differences between the old IRB database system and the eIRB system, only limited existing protocol information was transferred into eIRB (IRB protocol number, PI name, study title, approval and expiry date and, for some protocols, an administrative contact). Thus, at time of continuing review, investigators must complete the entire eIRB protocol form and attach applicable study materials, such as consent forms. Specific instructions appear in the eIRB continuing review form.
The IRB has created help documents to assist in this one-time conversion from paper to eIRB. Please visit the IRB website.
A training class, eIRB Conversion 101, is also being offered to assist investigators in this process. Details on upcoming classes are forthcoming.
Log into the eIRB system to view active protocols and, if applicable, to complete the continuing review conversion for protocols nearing expiration. Please note that changes to the protocol will not be allowed when converting to eIRB at time of continuing review.
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