Detailed DSM Plan Checklist
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Was item included in the DSM plan? | Included? | |
---|---|---|
Yes | No | |
Brief description of the protocol | ||
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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