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

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

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Was item included in the DSM plan?	Included?
Was item included in the DSM plan?	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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