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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