Progress Reports, Renewal, and Revisions

A yearly progress report is required. Any changes in a study (such as funding source, procedures, changes in protocol or consents, etc.) must be reviewed prior to implementation on the CRU.

Any requests for changes in an approved protocol must be submitted in writing with IRB materials (if relevant) and detailed explanations of the request and rationale. The Investigator should indicate rationale and relevance of the requested change with respect to the:

  1. Science
  2. Safety
  3. Resources requested

This request will undergo administrative review and triage (Administrator, Medical Director and/or Assistant Director, RSAs as indicated, Nurse Manager as indicated).

PIs of studies that have been in effect and active for more than years without full review may be requested to reapply (on the current application form). In addition to the standard application materials, all updated IRB materials will be concurrently submitted for CRC-SAC review and the PI will be requested to present a narrative describing progress and plans. This reapplication will be reviewed for approval of continuation or requests for revision will be presented. An in-service may be waived upon approval unless the CRC staff requests a refresher in-service. The study will not be halted during the review process.

Contact Us

Find out if CRC can assist you with your research efforts:

Clinical Research Centers
Tel: 212-241-6045

Hours of Operation
Monday – Friday, 7am until 7pm