McLeod HealthInstitutional Review Board
Continuing Review Form
Complete this form in its entirety. Do not add or delete any fields or form will be returned for correction.
Please submit this form and a copy of the consent form to the Research Department at least one month prior to the IRB approval expiration date. All information must be typed.
IRB USE ONLY:Full Board Review Date:
Expedited Review Date:
Date of Submission:
Current IRB Approval Expiration Date:
Study Title:
Protocol #: Phase: Phase I Phase II Phase III Phase IV
I do not have a conflict of interest. Box must be checked to submit.
Principal Investigator: Research Coordinator:
Co-Principal Investigator:
Address:
Email: Telephone:
Current Protocol Status:
Open for new subject enrollment. Please submit a clean consent form for approval stamp.
Closed* to new enrollment; subjects continue treatment per protocol.
Closed* to new enrollment; subjects continue follow-up (or data collected) per protocol.
*For recent accrual closures, please also submit a Closure Form to the IRB Coordinator.
Current protocol version date: Current consent form version date:
Have there been any changes to the protocol since the last IRB review? Yes No
If yes, please identify the type(s) of update(s):
Investigator Brochure Addendum # Update #
Amendment # Revision # Editorial Changes (protocol)
Memorandum # Annual Report (dated)
Have there been any changes to the consent form since the last IRB review? Yes No
If yes, please summarize:
Was/were the change(s) listed above previously reported to the IRB? Yes No
If no, please explain why not:
Documentation to be submitted with this form electronically (checklist)
Attach a clean copy of the informed consent form (for new approval stamp).
Attach a copy of the assent form for children studies if applicable.
Attach the revised protocol.
Attach a copy of anyother updated document(s), including recruitment material.
ParticipantStatus Update:
How many subjects have been enrolled (consented) since last IRB review?
What is the total number of subjects currently in the study?
Have any subjects withdrawn from the study? Yes No
If yes, please explain:
Did the subjects have any complaints? Yes No
If yes, please describe:
Have there been any risk changes (i.e. physical, emotional, financial) for subjects in this study?
Yes No
If applicable, are adequate safeguards still in place for vulnerable subjects? Yes No
Was an audit or a monitor site visit conducted since the last IRB continuing review? Yes No
If yes, a copy of the report(s) must be sent to the IRB.
Were there any serious local adverse events or major protocol deviations since the IRB review?
Yes* No
*If yes, and you have not reported to the IRB, please submit the appropriate forms at this time.
ALL FORMS MUST BE SIGNED BY THE PI.
Principal Investigator (printed):
Principal Investigator Signature Date:
Co-Principal Investigator (printed):
Co-Principal Investigator Signature Date:
Please send this original form along with all relevant supporting documentation** (see checklist above) to:
Noah Kleckner, IRB Coordinator
McLeod Health - Research Department
(843) 777-2013
**PLEASE BE SURE TO SEND ALL DOCUMENTS TO IRB COORDINATOR ELECTRONICALLY.
FOR IRB REVIEWER USE ONLY:
Comments: ______
______
Primary Reviewer (printed):
Primary Reviewer Signature: Date:
FOR IRB OFFICE USE ONLY: Approved Deferred Conditional approval Disapproved
OtherIRB fees: Yes No
IRB Approval Date: IRB Expiration Date:
Initial Approval Letter Sent Date:
HIPAA Waiver of Authorization HIPAA Authorization IRB Waiver of Informed Consent
11/08, 3/11, 6/13, 5/15, 5/16, 4/17
1
Continuing Review FormApril 2017