Guidelines for Developing a Data and Safety Monitoring Plan: Appendix A

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