Data & Safety Monitoring Plan

The NIH has required, since October 2000 that all Phase I and Phase II clinical trials sponsored by the NIH have a data and safety monitoring plan as part of the protocol. The National GCRC Working Committee now recommends that all GCRC protocols (not just Phase I and Phase II) have data and safety monitoring plans that include periodic review and reporting as appropriate for the study.

All protocols that are conducted through the GCRC at Stony Brook are required to have a Safety Monitoring Plan. The plan should be submitted to the GCRC and will be approved by the General Advisory Committee. Plans may vary from simple to more detailed, depending on the level of risk imposed on the research subjects in the course of the research protocol. The plan will need to address risk, how risk will be minimized, safety tests/measures that will be utilized to protect subjects, a process for characterizing and reporting of adverse events, and how study investigators will oversee research subject safety.

See DSMP Template here