The following human research studies may utilize DSMB services:
- IRB approved investigator-initiated studies.
- Unapproved federal, nonfederal, or investigator-initiated studies in the proposal stage. The DSMB administrator can review the Safety Monitoring plan and make suggestions. The DSMB will provide a letter of support describing its role in monitoring the study along with a copy of the standing DSMB charter.
- The IRB may also refer studies under review.
What to Submit
The following information should be submitted to the DSMB administrator:
- DSMB Study Information Form
- Protocol and IRB recommendations
- Safety Monitoring Plan from grant (if applicable)
Interim Review of Data
After the DSMB has accepted the Data Safety Plan and protocol, the investigator is required to submit reports to the DSMB as outlined in the DSMB acceptance letter. Failure of the PI to adhere to the schedule may result in stoppage of the study. The report should follow the DSMB Reporting Template.