Submitting a Study for Amendment Review

OVERVIEW

This Quickguide provides instructions for Coordinating Centers for submitting an Amendment for review..

BEFORE YOU BEGIN

  • The Study Chair/Coordinating Center 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 notification and link to complete the CIRB Amendment Application via IRBManager to the Coordinating Center, the submission deadline and next available meeting date is included in the notification. A Word version of the CIRB Amendment Review Application and the Waiver of Consent Request Supplemental Form, are also available, if required.
Steps

COORDINATING CENTER SUBMITS APPLICATION

The Coordinating Center completes the CIRB application via IRBManager 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/patient 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/COORDINATING CENTER AN OUTCOME LETTER

Within seven days of the meeting, the CIRB emails the Study Chair and Coordinating Center an outcome letter summarizing the board’s determination.  Possible outcomes are: Approved, Approved Pending Modifications, Approved with Query or Table

Steps

COORDINATING CENTER RESPONDS TO CIRB

The Coordinating Center responds to the CIRB’s modifications or query by completing the application via IRBManager and 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 COORDINATING CENTER’S RESPONSE

The CIRB reviews the Coordinating Center’s response either by expedited review or convened CIRB review. If convened CIRB review is required, the submission will be reviewed at the next available 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 and Coordinating Center 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: November 29, 2021