Submitting a Study for Amendment Review

OVERVIEW

This Quickguide provides instructions for Study Chairs for submitting an amendment for review.

BEFORE YOU BEGIN

  • The Study Chair submits the study amendment to the Cancer Therapy Evaluation Program (CTEP) or Division of Cancer Prevention (DCP) for scientific review.  Once approved by CTEP or DCP, an Approval on Hold (AOH) Letter is emailed to the Study Chair and the CIRB.  
  • After receiving the AOH Letter, the CIRB emails the Study Chair the CIRB amendment application, and the submission deadline for the next CIRB meeting. You can also download a copy of the CIRB Amendment Review Application and the Waiver of Consent Request Supplemental Form, if required. 

Submitting a Study for Amendment Review 

Steps

STUDY CHAIR SUBMITS APPLICATION

The Study Chair emails the CIRB application to the CIRB by the submission deadline, 14 days before the scheduled CIRB meeting.  Complete submission includes: CIRB application, protocol, model consent form, and, as applicable, Investigator's Brochure, recruitment material, and patient reported outcomes.

Steps

CIRB REVIEWS SUBMISSION

The CIRB Operations Office determines if the amendment review qualifies for expedited review or if it requires full board review. Expedited reviews are sent to the CIRB Chair and full board reviews are reviewed at a convened meeting. 

Steps

CIRB SENDS STUDY CHAIR AN OUTCOME LETTER

Within seven days of meeting, the CIRB emails the Study Chair an outcome letter summarizing the board’s determination.  Possible outcomes are: Approval, Approved Pending Modifications or Tabled.

Steps

STUDY CHAIR RESPONDS TO CIRB

The Study Chair responds to the CIRB’s recommendations for study modifications by submitting the necessary revised documents within 14 days. For more information please refer to the Study Chair Response instructions. A sample Change Memo is also available as a reference.

Steps

CIRB REVIEWS STUDY CHAIR’S RESPONSE

The CIRB reviews the Study Chair’s response either by expedited review or convened CIRB review. If convened CIRB review is required, the submission will be reviewed at the next CIRB meeting and an approval will be issued or additional modifications will be required. If additional modifications are required, the process repeats at step 3.

Steps

CIRB ISSUES APPROVAL

Following approval, the CIRB issues an Approval Letter to the Study Chair within two days of the determination. 

USEFUL TIPS

CIRB amendment review occurs prior to final NCI approval of the study, and before the study is activated by the Network and distributed to institutions.

 

 

Updated: March 12, 2021