Detailed DSM Plan Checklist
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| Was item included in the DSM plan? | Included? | |
|---|---|---|
| Yes | No | |
| 1. Heading | ||
| Title, Grant number, PI and Medical Monitor name | ||
| 2. Summary of the protocol | ||
| Brief description of the protocol, procedures and table for schedule of events | ||
| Primary and secondary objectives and outcome measures | ||
| Inclusion and Exclusion criteria | ||
| Sample size and power calculation | ||
| 3. Trial management | ||
| List of participating/enrolling clinics or data collection centers | ||
| Planned enrollment timetable (graph showing time vs. projected cumulative enrollment)* | ||
| Target population distribution (e.g., gender, minorities, etc) | ||
| 4. Data management | ||
| Data acquisition and transmission, data entry methods | ||
| Data security and protecting confidentiality | ||
| Statistical analysis plan | ||
| 5. QA and QC plan | ||
| Procedures in place to ensure the integrity and validity of the data | ||
| Procedures to guarantee the accuracy and completeness of the data set | ||
| 6. Regulatory | ||
| Reporting process for AEs and SAEs | ||
| SAE reporting in medication trials: FDA, IRB and NIDA | ||
| SAE reporting in non-medication trials: IRB and NIDA | ||
| Process of reporting IRB actions to NIDA | ||
| Report of changes or amendments made to the protocol** | ||
| 7. Trial Safety | ||
| Potential risks and benefits for participants | ||
| Risk mitigation plan (management of SAE and other study risks) | ||
| Trial stopping rules | ||
| Process of AE/SAE collection, assessing by PI and/or medical monitor and reporting | ||
| AE/SAE follow up plan | ||
| 8. Trial efficacy | ||
| Plans for interim analysis (if applicable) | ||
| 9. Administration of DSM plan | ||
| Responsibility for data and safety monitoring | ||
| Frequency of monitoring | ||
| Conflict of interest | ||
| DSM report (to be submitted to NIDA PO annually) | ||
| Content of DSM report | ||
| Brief description of progress | ||
| Enrollment update (participants who are randomized in the trial) | ||
| Retention and dsiposition of participants (active, completed, and terminated) | ||
| AE/SAE listings | ||
| Regulatory issues (amendments, protocol deviations, IRB reports, QA issues) | ||
| 10. DSM Board (if applicable DSMB plan) | ||
| Members and affiliations | ||
| Conflict of interest | ||
| Frequency of meetings | ||
| Monitoring activities (initial and ongoing reviews) | ||
| Reporting DSMB minutes to IRB, NIDA and FDA (if applicable) | ||
*Enrollment: participants who are randomized and received treatment in the trial
**Changes made to protocol must be pre-approved by NIDA PO