Every protocol supported by the General Clinical Research Center (GCRC) must establish a written plan for monitoring participants’ safety, and data integrity and security. The data and safety monitoring plan (DSMP) must be commensurate with protocol risks, size and complexity. The DSMP is considered an element of the protocol, and must be revised as indicated by protocol changes or interim data analyses.
The GCRC Data and Safety Monitoring Plan is part of the GCRC application. Click here to view the DSMP policy, which can also be found in the Downloads section of the website.
Questions regarding the DSMP can be directed to the GCRC Research Subjects' Advocate, Laure Campbell at 624-2621 or campb020@umn.edu.