Submitting a Study for Initial Review

OVERVIEW

This Quickguide provides Study Chairs with an overview of the Initial Review process.
 

BEFORE YOU BEGIN

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

Steps

CHAIR SUBMITS APPLICATION BY THE SUBMISSION DEADLINE

The Study Chair emails the CIRB application to the CIRB by the submission deadline, 14 days before the scheduled CIRB meeting. The completed 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 reviews the complete submission at a scheduled meeting.  On rare occasions, a study qualifies for expedited initial review per the regulations.  Expedited reviews are sent to the CIRB Chair for review.

Steps

CIRB SENDS STUDY CHAIR AN OUTCOME LETTER

Within seven days following the CIRB meeting, the CIRB emails an outcome letter to the Study Chair. The possible outcomes are: Approved Pending Modifications or Tabled. The letter states the board’s stipulations and recommendations for changes to the protocol.  If there are questions related to the stipulations, a conference call may be arranged to discuss.

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. 

Steps

CIRB REVIEWS STUDY CHAIR’S RESPONSE

The CIRB reviews the Study Chair’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 within two days of the approval determination.

USEFUL TIPS

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

 

 

Updated: February 22, 2019