December 21, 2023
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The purpose of the notice is to inform all NIAAA applicants of the revised Data and Safety Monitoring Plan (DSMP) guidelines for all extramural NIAAA-funded, NIH-defined clinical trials.
Please note, this change is not considered an increase in burden on applicants as a DSMP is required by NIH for all grant applications proposing a clinical trial. The NIAAA DSMP guidelines provide applicants with NIAAA’s expectations on reporting adverse events and alcohol-specific research in addition to the requirements set-forth in the NIH Grants Policy Statement and current SF424 (R&R).
The revised DSMP guidelines are effective for applications awarded after November 15, 2023. If any of the critical elements are not addressed in the DSMP submitted with the original grant application, the NIAAA Project Officer assigned to the grant will contact the recipient to address the elements prior to grant award.
The revised DSMP guidelines can be found at: https://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/ResourcesAppGrantees/guidelines.htm
Megan Ryan
National Institute on Alcohol Abuse and Alcoholism/Office of the Director
Telephone: 301-443-4225
Email: [email protected]
and Human Services (HHS)
