Study Amendment Checklist
(This checklist is for your use only, it does NOT need to be submitted to the HIC)
Protocol #
Date:
Principal Investigator:
Approval Expiration Date:
HIC protocol application is the most recently reviewed/approved version
Yes
No
There are no outstanding previous requests from the IRB regarding the protocol. (If there is, please contact
the HIC for a status update of the request. The HIC will not accept any new submissions while other requests
are pending).
Yes
No
An amendment for a change of PI is signed off on by the Department Chair or Dean (for professional schools)
Yes
No
The amendment, when applicable, has been reviewed by any of the following: Hartford Hospital, UCONN,
MRRC, VA, PRC, PPRC, RSC, RDRC, FDA, Other.
Yes
No
Human Subject Protection Training and HIPAA training has been checked when adding new study staff and coinvestigators. COI Disclosure to the University has been submitted if adding co-investigators. (If these
requirements have not been met, the individual(s) cannot be added to the study until the training and/or COI
disclosure is complete)
Yes
No
When making changes to the consent form, consideration has been given to using a consent addendum
instead of having the subject sign an entirely new consent form.
Yes
No
All changes have been made consistently throughout the HIC protocol application and consent forms.
(consider using the "find" function in Word to check this).
Yes
No
When changing Certificate of Confidentiality (COC ) status from “pending” to “in place”, the protocol
application and consent forms have been revised to reflect receipt of the COC.
Yes
No
For Sponsored studies, the tracked version of the sponsor protocol, sponsor summary of changes, and new
Investigator Brochure have been included as applicable.
Yes
No
The amendment request form gives a justification for the proposed changes.
Yes
No
The track change feature in Word has been used to indicate revision.(see http://www.yale.edu/hrpp/formstemplates/biomedical.html for instructions on how to use the track changes feature in Microsoft Word)
Yes
No
Version control dates and numbers, if used, have been updated.
Yes
No
Submitting one tracked change copy and two clean copies of the amended documents
Yes
No
Please see the following link for more information about submitting an amendment request:
http://www.yale.edu/hrpp/questions.html#AmendmentsHIC