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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?
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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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