At Continuing Review, Tufts PI/research team is to complete a Form 5 specific to the research activity occurring at Tufts Medical Center / Tufts University. This means that the enrollment status, enrollment numbers, research team members, etc. will reflect only Tufts’ research activities.
In addition to the Tufts’ Form 5, if an IRB Authorization Agreements (IAA) is in place for this study where Tufts is the IRB of record for an external site(s) (i.e. non-Tufts site), it is also required to complete and submit a Form 5 on behalf of each external site. For assistance on how to complete a Form 5 for external sites, read through the following section-by-section guidance:
Additionally, a summary of the completed self-audit must be submitted to the Tufts Health Sciences IRB at the time of continuing review from the Tufts PI. Be sure to describe any issues identified during the self-audit. The original self-audit checklists need to be available upon request from the Tufts Health Sciences IRB.
Feel free to contact the IRB Office for assistance with any questions at the numbers listed in the pages below: