Submitting a Study for Continuing Review

OVERVIEW

This Quickguide provides Network Group coordinating office staff and Study Chairs with an overview of the continuing review process.

BEFORE YOU BEGIN

  • The Network Group coordinating office staff receives a reminder email  and access to the online continuing review application in IRBManager from the CIRB. The email and application indicates the study's expiration date and the application due date. This email serves as an important reminder to ensure the study's approval does not lapse. You can also download a copy of the CIRB Continuing Review Application.
Submitting A Study For Continuing Review graphic

STEPS

Steps

NETWORK GROUP COORDINATING STAFF SUBMITS APPLICATION

The Network Group coordinating office staff completes and submits the Continuing Review through IRBManager to the CIRB by the submission deadline, 14 days before the scheduled CIRB meeting.
 
A complete submission package includes the CIRB application, protocol, model consent form, and, if applicable, Investigator's Brochure, recruitment material, and patient reported outcomes.

 

Steps

CIRB REVIEWS SUBMISSION

The CIRB Operations Office determines whether the continuing 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 following the meeting, the CIRB emails an Outcome Letter to the Study Chair and Network Group coordinating office staff. The possible outcomes are: Approved, Approved Pending Modifications, or Tabled. The letter states the board’s stipulations and recommendations for changes to the protocol.

Steps

NETWORK GROUP COORDINATING OFFICE STAFF RESPONDS TO CIRB

The Network Group coordinating office staff responds to the CIRB’s recommendations for study modifications by submitting the necessary revised documents within 14 days.

Steps

CIRB REVIEWS NETWORK GROUP COORDINATING OFFICE STAFF'S RESPONSE

The CIRB reviews the Network Group coordinating office staff's response via expedited review procedures or convened CIRB review. If convened review is required, the submission will be reviewed at the next CIRB meeting. At that point, 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

The CIRB issues an Approval Letter to the Study Chair and Network Group coordinating office staff within two days of the approval determination. 

USEFUL TIPS

Continuing review is an interaction between the Network Group coordinating office staff and Study Chair and the CIRB and does not involve NCI review or approval.

 

 

Updated: June 11, 2021