Key Dates

Related Announcements

• August 30, 2022 - Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants. See Notice NOT-OD-22-205.
• January 22, 2020 - Additional Guidance on the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. See Notice NOT-OD-20-058.
• March 26, 2019 - NIH Releases Protocol Template for Behavioral and Social Sciences Research Involving Humans. See Notice NOT-OD-19-092.
• October 26, 2018 - Notice of Intent to Publish Parent Funding Opportunity Announcements for Basic Experimental Studies with Humans. See Notice NOT-OD-19-024.
• July 20, 2018 - Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants. See Notice NOT-OD-18-212.
• May 11, 2018 - Transition from Inclusion Management System to New Human Subjects System (HSS) as of June 9, 2018. See Notice NOT-OD-18-179.
• January 18, 2018 - Grant Application Instruction Correction for Training Grants with Human Subjects Involvement. See Notice: NOT-OD-18-128.
• January 12, 2018 - Reminder: Updated Appendix Policy Eliminates Clinical Trial-Related Materials for NIH/AHRQ/NIOSH Applications Submitted to Due Dates on or After January 25, 2018. See Notice NOT-OD-18-126.
• December 1, 2017 - Revision: The NIH Announces New Review Criteria for Career Development Award Applications Involving Clinical Trials. See Notice: NOT-OD-18-109.
• November 30, 2017 - Reminder: Policy on Funding Opportunity Announcements (FOA) for Clinical Trials Takes Effect January 25, 2018. See Notice: NOT-OD-18-106.
• October 25, 2017 - NIH Plans for Clinical Trial Specific Parent R01 and Parent R21 Funding Opportunity Announcements. See Notice: NOT-OD-18-010.
• October 11, 2017 - Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. See Notice: NOT-OD-18-004.
• October 11, 2017 - Guidance on Exceptions to the NIH Single IRB Policy. See Notice: NOT-OD-18-003.
• October 6, 2017 - The NIH Announces New Review Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship Applications Involving Research Experiences in Clinical Trials. See Notice: NOT-OD-17-122.
• October 6, 2017 - The NIH Announces New Review Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants Involving Research Experiences in Clinical Trials. See Notice: NOT-OD-17-123.
• September 21, 2017 - The NIH Announces New Review Criteria for Research Project Applications Involving Clinical Trials. See Notice NOT-OD-17-118.
• August 2, 2017 - Updated Appendix Policy Eliminates Clinical Trial-Related Materials for NIH/AHRQ/NIOSH Applications Submitted to Due Dates on or After January 25, 2018. See Notice: NOT-OD-17-098.
• June 16, 2017 - Revision: Notice of Extension of Effective Date for Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. See Notice: NOT-OD-17-076.
• May 2, 2017 - NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials. See Notice: NOT-OD-17-064.
• April 27, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See Notice: NOT-OD-17-062.
• February 17, 2017 - Update on Clinical Trial Funding Opportunity Announcement Policy. See Notice: NOT-OD-17-043.
• September 16, 2016 - NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. See Notice: NOT-OD-16-149.
• September 16, 2016 - Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials. See Notice: NOT-OD-16-148.
• June 21, 2016 - Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. See Notice: NOT-OD-16-094. 
• June 21, 2016 - Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research. See Notice: NOT-OD-16-109.
• October 23, 2014 - Notice of Revised NIH Definition of Clinical Trial. See Notice: NOT-OD-15-015.

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

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.

NIDA Policy on Monitoring and Reporting Recruitment and Retention of Participants in Clinical 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.

Inquiries

Please direct all inquiries to:

Please direct all policy related inquiries to:

Katia Delrahim Howlett, PhD., MPP, MBA
National Institute on Drug Abuse
Phone: 301-451-1011
Email: katia.delrahim-howlett@nih.gov

Amanda Burton, PhD.
National Institute on Drug Abuse
Phone: 301-827-4171
Email: amanda.burton@nih.gov

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.