Data and Safety Monitoring Plan (DSMP)

A quality assurance (QA) plan that establishes the overall framework for ensuring the safety of participant(s) and the validity and integrity of the data. The DSMP should specify the following: 1) A brief description of the study design, 2) potential risk(s) and benefit(s) for participating in the study, 3) procedures for data review and reportable events, 4) roles and responsibilities of study staff and monitoring entity (body), 5) content and format of the data and safety monitoring report, and 6) data management, Quality Control (QC) and Quality Assurance (QA). A DSMP is commensurate with the risks involved with the research study and may include a Data Monitoring Committee (DMC), Data and Safety Monitoring Board (DSMB) or Data and Safety Monitoring Committee (DSMC). NIH National Institute of Aging (NIA): Glossary of Clinical Research Terms