The safety monitoring plan ensures the safety of the participants to the greatest extent possible. It also helps:
- Plan the ongoing oversight and monitoring of the conduct of the study to ensure the validity and integrity of the data produced.
- Document the conditions and monitoring frequency regarding the decision as to whether or not the study should continue or be stopped.
- Specify the responsibilities (charter) of the DSMB (Data and Safety Monitoring Board) – if a DSMB is required or a TEC (Treatment Effects Committee).
