September 29, 2023
National Institute on Drug Abuse (NIDA)
The NIH launched a series of initiatives to enhance the accountability and transparency of clinical research, and in particular, clinical trial research (https://grants.nih.gov/policy/clinical-trials.htm). In addition to the NIH policies and efforts, the National Institute on Drug Abuse (NIDA) has implemented an additional clinical research recruitment and retention monitoring and reporting policy for all NIDA-supported grants and cooperative agreements beginning October 1, 2023 (FY24) to facilitate the achievement of research objectives and to ensure that NIDA remains a responsible steward of public funds.
For the extramural research community, this Guide Notice summarizes the NIDA policy and effort related to the monitoring and reporting of recruitment and retention in clinical research throughout the award life cycle for identified clinical research projects and/or clinical research studies supported by NIDA. NIDA will work with Principal Investigators (PIs) to establish realistic recruitment and retention milestones of a clinical research project and/or a clinical research study, as needed. Progress will be regularly monitored throughout the course of the research.
This policy applies to all active clinical research projects and/or clinical research studies supported by NIDA. This policy ensures that investigators work with their program official or contracting officer's representative to establish recruitment and retention milestones of a clinical research project and/or a clinical research study and establishes that progress must be reported based on the identified need by the program official or contracting officer's representative throughout the course of the award. NIH policy requires certain information regarding research that involves human subjects. The terms outlined here are in addition to and not in lieu of other NIH policies, including the Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan in the SF424 Application Guide and the Research Performance Progress Report (RPPR) which require annual reporting, at a minimum, per NIH reporting requirements for study enrollment. The NIDA policy is aligned with the NIH Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, Policy for the Enrollment of Participants in Clinical Trials.
PIs of applicable awards with identified clinical research projects and/or clinical research studies necessitating reporting in addition to the annual reporting requirement will be prompted by an automatically generated email from the NIDA Tracking Recruitment Assessment Query (TRAQ) system to update recruitment data within the NIH Human Subjects System and, as appropriate, retention data (e.g., participants that complete and those that withdraw from the clinical research project and/or the clinical research study) within the NIDA TRAQ system. PIs can use their eRA commons username and password to enter these data.
For more information on the policy, please see: Special Considerations for NIDA Funding Opportunities and Awards.
Please direct all policy related inquiries to:
Katia Delrahim Howlett, PhD., MPP, MBA
National Institute on Drug Abuse
Amanda Burton, PhD.
National Institute on Drug Abuse
Please direct all questions regarding recruitment and retention of participants, about specific grants and cooperative agreements, to the NIDA Program Official or Contracting Officer's Representative listed on the Notice of Award.