DSM Protocol Checklist
The DSM Protocol should contain:
- Study Risk Assessment
- Description of anticipated adverse events and their expected frequency
- Describe the steps you will take to minimize the risks/discomforts to subjects
- Description of safety monitoring
- Describe which research results, if any, will be made available to subjects and/or to their physicians
- Description of how AEs (adverse events) are graded
- Plan for AE reporting
- Describe who will perform the safety reviews: Individual versus Contracted Research Organization (CRO), or a Data and Safety Monitoring Board (DSMB)
The DSM Plan section of the protocol should describe:
- Primary and secondary outcome measures
- Inclusion/exclusion criteria
- Sample size
- List of participating enrolling clinics or data collection centers
- Projected timetable
- Target population distribution (e.g., women, minorities, etc.)
- Data acquisition and transmission
- Data entry methods
- Data analysis plan
- Quality assurance plan
- Reporting mechanisms of AEs/SAEs to the IRB, FDA, and NIDA.
- Reporting mechanisms of IRB actions to NIDA
- Report of changes or amendments to the protocol
- Trial stopping rules
- Conflict of interest
- Potential risks and benefits for participants
- Collection and reporting of AEs and SAEs
- Management of SAEs or other study risks
- Plans for Interim Analysis of efficacy data
- Responsibility for data and safety monitoring
- Frequency of DSM reviews
- Content of DSM report
- DSM Board Plan (if applicable)
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