IRB-HSR: Approval Comment Form for Protocol Continuations
IRB-HSR Protocol #:
Expedited Review
Full Board Review
Modification
Meeting Date:
If protocol involves Gene Transfer- approval may be only be granted for 6 months.
OK? Review Criteria:
Comments
If full board, create a folder for this studies review documents or verify this is not necessary because study is expedited.
MAIN PAGE REVIEW
STATUS : Review the Current Status checked on Status Form
No change
Status Change This change will be considered a Receipt)
Approval form comments: Protocol status changed from
Update database as necessary. Add approval comment and update
__________________to _____________ per Status Form OR
Regulatory page as necessary with expedited criteria #8 choices
per Protocol Status Change Form on file with this continuation.
Open to Enrollment
Closed, subjects being treated
Database Closed
Database Open
Temporarily Closed to Enrollment
Closed, Follow-up only
Closed to enrollment, no subjects enrolled
Data Analysis Only
RE-OPEN with this continuation:
Continuation Approval form comments: This Protocol was
Separate reopening event is required:
previously closed/expired on (insert). With the approval of this
Event type = Approval Protocol reopening
continuation, the protocol is now re-opened with the status of (insert).
Review Type = same as Continuation Review
Agenda = None
Reopening Approval form comments: Protocol reopened with the
If 5 year update due and not completed, reopen to status of: Closed to Continuation approved on (insert date)
Enrollment Pending 5 Year Update
Verify that the 5 year update is not due. If due, be sure it has been processed before the continuation is placed on the agenda for approval

If the team only has a few more subjects to enroll OR there are other extenuating circumstances, you may grant an extension of 1 year.
Enrollment Modification: Refer to ADMINISTRATIVE PREENROLLMENT
REVIEW AND ASSURANCE CHECKLIST- MODIFICATIONS
1. Review how many subjects have enrolled and update Subjects
Studied field in database as necessary.
Approval Form Comment if there was over enrollment:
2. Update the Enrollment table at the bottom of the main page with
With this submission the minor violation of over-enrollment was noted.
yearly and cumulative information.
Study was approved to enroll x and Y were enrolled.
3. Process any enrollment number modifications per AG 3-4
4. If over-enrollment has occurred add Comment and if open to
enrollment, request a modification to enrollment numbers.
Verify any Comment on Main page of the database is resolved or confirm this is NA. Add receipt comments to the approval comment.
EVENTS: Print Events/AE reports for all continuations. IF Full Board review is required, create e-files for these documents and place in review
folder for agenda files.
REGULATORY PAGE CHECK:
IF DSMB, verify DSMB report are on file.
NA
For Cancer Center DSMC: The CCDSMC meets every month but only produces a report if there are issues. If a PAM review has occurred, there
should be a DSMC letter for each PAM review. The DSMC does not review studies with no enrollment OR those in Follow Up
If new C of C approval submitted with continuation, enter expiration date into Regulatory page if applicable. If there is no expiration date, place
a comment on the main page stating that the C of C expires when the IND/IDE is terminated.
NA
If study has an expiration date entered for C of C, confirm the C of C is not expired.

If it is expired /request C of C extension application or C of C approval from the study team.

If not received, the IRB approval will be allowed to expire
IF study is approved to enroll Prisoners:
Approval Form Comment:
Full Board: Prisoner Representative must be involved in the review.
For all studies add: A majority of the IRB (exclusive of the
See AG 3-34 for additional info.
prisoner representative) has no association with the prison(s)
NA
ADD “Research Involving Prisoners Checklist” to Scientific Reviewers
involved and a qualified prisoner representative was involved in the
documents. If research is done inside the Bureau of Prisons, the
review if full board review add: and voted on the continuation. For
checklist MUST be completed by the Prisoner Representative.
all studies add: The Prisoner Representative concurred with the
permission for prisoners to enroll as subjects in the research.
Expedited:

If the study does not involve an interaction/ intervention (e.g. chart
review under waiver of consent) or the study has had no enrollment, If the continuation is being sent to the Full Board, DO NOT add
the comment above until the approval is processed.
the prisoner representative and the checklist are NOT required.
If the continuation meets expedited review criteria, study has enrolled
subjects and consent has not been waived, the Prisoner Checklist must
be completed by the Prisoner Representative.
For full board studies ONLY: If the study is approved to enroll children and 2 parent signatures are required: Verify if Wards of the
NA
State were enrolled.
If wards were enrolled without permission request protocol violation.
PEOPLE/PERSONNEL: Verify if any personnel changes are required
and update database and/or Status Form as necessary.
Version Date 5-12-15
Approval Form Comment: Modification expedited: Minimal
risk/Minor change: The following personnel changes were made per
the Status Form/Personnel Change Form on file with this
submission:
IRB-HSR: Approval Comment Form for Protocol Continuations
Verify training is current for all study personnel. Remove those with
expired training Print Certificate
Approval Form Comment: Modification expedited: Minimal
risk/Minor change: (insert names) were administratively removed
from this protocol due to expired Human Subject Protection
Training.
QUESTIONS: Review all answers. All questions should be addressed and the responses should be consistent with information in the database.
Update/clarify as necessary
1. Brief summary is present and consistent with remaining information. If attachments are noted, be sure they are attached and listed as
received.
2. Yes/NO response is required
3. Plans for the coming year are consistent with remaining info
4. Yes/No response is required. If YES, verify a mod has been approved to change funding source.
5. Verify response is consistent with page 1 and Reg Page. IF DSMB report is required it is either submitted previously, attached or there is a
comment such that there was not enough enrollment OR a board meeting is schedule in x timeframe.
6. Adverse events: IF NO AEs are submitted for the year per the AE report, the response should = NA. If AEs are present then the response
should =YES. Review AE report to see if these appear to be reported correctly. ( if no sponsor, then no external AEs should be present etc.)
Questions # 7-11 – Yes /NO response required
SIGNATURE: Verify the form is signed by the PI or typed in and have accompanying email from PI on file.
VERSIONS: Use the database to verify correct version dates.

Verify current consents are submitted. Print and stamp consents or verify this is not necessary. IF Full Board, move current consents and
protocols to the review folder.

IF full board, verify current protocol is also submitted and moved into agenda file folder.
RECEIPTS: List in the approval comments documents received. No
Approval Form Comment:
need to stamp these as received. “
On file with this submission are the following documents: (List)
EXPEDITED STUDIES ONLY
1. Make sure Expedited Categories are listed on Regulatory Page and on the Meeting Page as well. Use the Regulatory Insert feature to insert
expedited categories, copy and paste into comments on Meeting page.
2. Insert PLEASE REMEMBER text section of the regulatory insert information into the approval comment
EXPEDITED CATEGORIES : Continuation Review ONLY
Category 1-7
PER REGULATORY PAGE
Category # 8a
Follow up ONLY
Category # 8c
Data Analysis Only
Category # 8b
No Enrollment
Category # 9
Humanitarian Device Exemption
other:
Place on the agenda by using the Meeting Continuation view and changing responses to Y/N.
Change event to EXPEDITED and enter the expedited date. Then enter the expedited categories on this page.
FULL BOARD STUDIES ONLY
Scan (separately) Status Form, any attachments referred to in the report, and any DSMB reports
Move e versions of all documents and scans to agenda files
Place on the agenda by using the Meeting Continuation view and changing responses to Y/N.
MODIFICATION WITH CONTINUATION
IF AN EXPEDITED MODIFICATION IS APPROVED WITH THIS CONTINUATION – UPDATE VERSION DATES IN THE
DATABASE AT THE TIME OF APPROVAL.
Add Approval comment : Modification expedited: Minimal risk/Minor change: add description of modification
New Version Date:
IRB-HSR Protocol
Adult consent:
New Version Date:
Parental Permission:
New Version Date:
Adult/Parental Permission:
New Version Date:
Child’s Assent Form
New Version Date:
Adult Consent (other) specify:
New Version Date:
Consent Addendum:
New Version Date:
English Short Form
New Version Date:
Spanish Short Form
New Version Date:
Initials of Administrative Staff who completed this form:
Version Date 5-12-15