Notice Number: NOT-AA-17-004

Key Dates
Release Date: May 11, 2017

Issued by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

The purpose of the notice is to inform all NIAAA grant applicants of the revised Data and Safety Monitoring Plan (DSMP) requirements for all extramural NIAAA-funded clinical trials. The NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes (https://grants.nih.gov/grants/glossary.htm#ClinicalTrial.) The revised DSMP guidelines provide better alignment with local Institutional Review Board (IRB) requirements and provide NIAAA with enhanced oversight of NIAAA-funded clinical trials.

Please note, this change is not considered an increased in burden on applicants as many of these elements are already addressed in the grant proposal by most applicants. If the elements are discussed elsewhere in the grant proposal, the applicant should reference the location in the DSMP instead of repeating the information.

The revised DSMP requirements are effective for applications submitted after June 1, 2017. If any of the critical elements are not addressed in the original grant proposal, the grant applicant will be required to provide an updated DSMP to their Project Officer prior to grant award.

The revised DSMP guidelines can be found at: https://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/ResourcesAppGrantees/guidelines.htm

Inquiries

Please direct all inquiries to:

Megan Ryan
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4225
Email: [email protected]