The IRB expects a written DSMP for studies that are more than minimal risk or are clinical investigations involving a drug/biologic or device regardless of risk.

Studies utilizing the IRB’s Biomedical Protocol template or the ICTR’s protocol template, will be prompted to provide this information.

In the case of minimal risk research, the IRB may require a formal DSMP if the committee deems that monitoring of the study is needed to ensure the protection of the rights and welfare of subjects or data integrity, which could affect the welfare of future subjects.

See HRP-335 for IRB considerations in reviewing Data and Safety Monitoring Plans.