DSMB Submission Process
Initial Review by TraCS DSMB
If you are considering utilizing the NC TraCS DSMB to monitor your clinical trial, you must first submit a copy of your protocol or grant to the committee for review. After reviewing the protocol or grant, a determination will be made as to whether the TraCS DSMB is the appropriate body to provide oversight of your trial. Please note that the TraCS DSMB prefers to review research proposals in advance of submission to the IRB or a funding agency.
Submission of Materials for Initial Review of a Clinical Trial
- Cover letter describing phase, size, and type of clinical trial and anticipated role of the NC TraCS DSMB in monitoring the research.
- IRB Application and Master Protocol (as available)
- Grant application (if applicable)
- Safety Monitoring Plan or Human Subject Protection section of a grant
Acceptance of Clinical Trial for Oversight by NC TraCS DSMB
Once your protocol has been reviewed by the NC TraCS DSMB, an acceptance or contingency letter will be issued. This letter will include any questions or concerns identified by the DSMB and details regarding the role that the DSMB will play in monitoring the study and when the Investigator is expected to submit reports. Please respond to any DSMB contingencies as quickly as possible.
If the proposal is an NIH or Federal grant and the TraCS DSMB agrees to provide oversight for the clinical trial, a Letter of Support will be written that describes the TraCS DSMB and their role in monitoring the study and a copy of the DSMB Charter will be provided.
Interim Review of Data
Once a protocol has been accepted by the NC TraCS DSMB, the investigator will be expected to submit ongoing reports to the committee. Details regarding the frequency of reports will be outlined in the acceptance letter. It is the responsibility of the investigator to submit reports to the NC TraCS DSMB at the time points outlined in the DSMB acceptance letter. Please notify the NC TraCS DSMB administrator as the time nears for your next NC TraCS DSMB review.
Submission of Materials for Interim, Annual, or Safety Review
- Cover letter describing the type of review requested (interim review, safety review, etc.) as well as any other pertinent information.
- IRB Application, Consent Forms and Master protocol (most up to date)
- Copy of master protocol (including, where applicable, investigator's brochure)
- Safety Monitoring Plan or Human Subject Protection section of grant
- Protocol Data using one of the DSMB Report Templates below or other applicable format:
- DSMB Report Form for Moderate-High Risk Trials (unblinded)
- DSMB Report Form Template
- If study team is blinded, contact IDS to provide randomization codes to DSMB statistician or administrator
Once your protocol materials have been reviewed by the TraCS DSMB, a review letter will be issued to you. This letter will provide the DSMBs recommendations and whether the protocol should continue as approved. If there are any questions or contingencies to be answered by the Principal Investigator, these will be listed in the letter. A copy of the TraCS DSMB letter should be submitted to the IRB.
Submitting Research Materials for DSMB Review
All materials should be submitted in an electronic format to the NC TraCS DSMB Administrator,
Please remember to submit early and check our meeting dates and submission deadlines against your schedule/deadline. For questions, please call 919-966-6844.