Submitting a Study for Continuing Review (ETCTN)

STUDY CHAIR SUBMITS APPLICATION

The Study Chair emails the completed application 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.

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.

CIRB SENDS STUDY CHAIR AN OUTCOME LETTER

Within seven days following the meeting, the CIRB emails an Outcome Letter to the Study Chair. The possible outcomes are: Approved, Approved Pending Modifications, or Tabled. The letter states the board’s stipulations and recommendations for changes to the protocol.

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.

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.

CIRB ISSUES APPROVAL

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