Tag: data and safety

  • Important IRB Updates

    We have updated Data and Safety Monitoring guidance for Investigator-Initiated studies that are more than minimal risk. It is posted here under “DSMP, Site Monitoring, and DSMB Guidance,” under “Related Guidance.” Please note that some high-complexity studies do require external/independent monitoring, so please consult with the IRB, and/or Margaret Huber in the Office of Research…