A Data and Safety Monitoring Plan should include the following:
- Who is responsible for monitoring
- What data is being monitored consistent with the protocol
- What process is being used to collect data in the monitoring process
- The Adverse Event and Serious Adverse Event (AE & SAE) monitoring plan is to be clearly outlined
- Characteristics of the trial subject population
- The safety endpoints and how they are assessed
- Listing of expected Events / background AEs
- Who reviews the Safety Data
- Criteria for study discontinuation
- Need, or not, for a DSMB
- Identity of the Medical Monitor (if there is one).
