Was item included in the DSM plan? |
Included? |
Yes |
No |
Brief description of the protocol
|
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. |
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)
|
. |
. |