Form 5 for External Sites Under an IAA
How to Complete the Form 5 (Continuing Review) when Tufts Health Sciences IRB is the IRB of Record for an External Site(s) under an IRB Authorization Agreement(s)
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:
Cover Letter
- Based on your monitoring plan outlined in the protocol, at the time of continuing/annual review, the External Site Principal Investigator (PI) is required to provide an update on their monitoring plan. At minimum, this will include the completion and submission of the following self-audit tools to the Tufts PI from the external site:
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.
- If any issues meet the criteria for Reportable New Information, submit this on the Reportable New Information Form signed in original ink by the Tufts PI.
Study Information Section
- Tufts IRB# and Study Title
- External Site PI and their Contact Information (Telephone and Email)
- Preferred Coordinator and their Contact Information for the External Site
- External Site’s Institution, Department/Division and Mailing Address
Study-Specific Disclosure of Financial Interest
- This section applies for the external site. External sites may follow their own institution’s Conflict of Interest (COI) policy. Inform the Tufts Health Sciences IRB of any new or revised conflicts and any associated management plans.
Current Study Status
- This section should specifically reflect the research activity occurring at the external site. For example, if you have an IAA in place with Happy Valley Hospital (HVH) and you are open to enrollment at that site, but the Tufts site is permanently closed to subject enrollment, the HVH Form 5 should reflect that this study is open to enrollment while the Tufts’ Form 5 will indicate that it is closed to enrollment.
Enrollment Status
- This section should specifically reflect the enrollment numbers that have occurred at the external site.
- The total numbers in this section should reflect the total number of subjects at this specific external site rather than for the study overall (i.e. it should not include the Tufts enrollment numbers or numbers from any other sites).
- If the external site is not enrolling subjects with an informed consent form, do not leave the fields blank. Indicate “N/A” throughout this section.
Study activity since the study’s most recent IRB Review (initial or continuing)
- This section should specifically reflect the study activity that has occurred at the external site since the most recent IRB review (initial or continuing).
Administrative Annual Review
- This section applies for the external site. Please complete.
IF THIS STUDY QUALIFIES FOR ADMINISTRATIVE ANNUAL REVIEW:
Investigator Acknowledgement
- This section is only applicable if this study qualifies for Administrative Annual Review, in which case the sections below do not need to be completed. (Refer to the “Administrative Annual Review” section in the link above for this information.)
- The External Site PI must sign this section in original ink.
- The External Site PI must submit the completed Form 5 to the Tufts PI for review, who will then include it with their Administrative Annual Review submission.
IF THIS STUDY QUALIFIES FOR CONTINUING REVIEW, THE FORM 5 MUST BE COMPLETED TO ITS ENTIRETY, STARTING HERE:
Investigator Acknowledgement
- A signature under this section is not required for studies that require a continuing review, since this section is intended only for studies that are eligible for Administrative Annual Review. Please sign in the space provided at the end of the form.
Location of Research Study
- The location listed should specify and describe where the research procedures are occurring at the external site.
- The external site must be listed under “Outside institutions where Tufts Health Sciences IRB is the designated IRB of record”.
Current Funding
- This section applies for the external site. Please complete.
Mandatory Human Subjects Protection Education
- This section should only reflect the research team members who are affiliated with the external site.
- In order to fulfill the educational requirements, research team members from the external site have the option of completing one of the following::
- Tufts Health Sciences IRB’s CITI Education Requirement
- The external site’s IRB’s educational requirements – Submit documentation (i.e. CITI completion report, acknowledgment from the external site’s IRB) confirming the external site’s requirements have been met.
- Good Clinical Practice (GCP) Training applies for the external site if the study meets NIH’s definition of a clinical trial, regardless of the funding source.
Blood-borne Pathogen Training
- This section applies for the external site. Please complete.
- Contact the external site’s biosafety officer with any questions about this training, as needed.
Point of Care Pregnancy Testing
- This section applies for the external site. Please complete.
- Contact the Tufts PI to determine whether this section is applicable.
Amendment
- This section applies for the external site. Please complete.
Study Documents
- This section applies for the external site. Please complete.
Enrollment of Non-English Speaking Subjects
- This section should specifically reflect the experience with enrolling non-English speaking subjects at the external site, as applicable.
Documents to Submit for Continuing Review
- Submit all documentation as applicable. However, if the external site is utilizing the exact same documents as the Tufts’ site, the IRB does not require duplicate copies for review.
Investigator Acknowledgement
- The External Site PI must sign this section in original ink.
- The External Site PI must submit the completed Form 5 to the Tufts PI for review, who will then include it with their Continuing Review submission.
When you’re prompted to sign the Investigator Acknowledgement, submit the Form 5 to the Tufts’ PI for review and submission to 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:
- General Contact Information for the Tufts Health Sciences IRB
- IRB Office Staff Contact Information