Key Dates

Related Announcements

• April 17, 2023 - Update to Policy and Procedures for the Reporting of Human Subjects Enrollment Data for NIA Clinical Research Trials/Studies. See Notice NOT-AG-23-017. 
• June 17, 2021 - NIA Announces New Policy and Procedures for the Reporting of Human Subjects Enrollment Data for NIA Clinical Research Trials/Studies. See Notice NOT-AG-21-029.

Issued by

National Institute on Aging (NIA)

Purpose

This Notice informs the research community of the National Institute on Aging’s policy and procedures for supporting NIA-funded clinical research and details the requirements and expectations of NIA-funded investigators.

Background

NIA, one of the 27 Institutes and Centers (ICs) of the National Institutes of Health (NIH), leads the federal government in conducting and supporting research on aging and the health and well-being of older people. Through NIA’s extramural research program, the Institute oversees a robust clinical research portfolio and generates a vast collection of unique data.

NIA tracks the enrollment of all NIA-funded clinical research through its Clinical Research Operations & Management System (CROMS). One of the biggest hurdles in advancing aging research is participant recruitment and retention into NIA-funded clinical trials/studies, particularly among heterogeneous and traditionally understudied populations. To better assist NIA- supported clinical research, NIA developed a process in CROMS to track accrual enrollment and communicate when planned benchmarks are not obtained. This tool enables NIA to manage the enrollment performance of its clinical research portfolio by allowing the ability to track and report on extramural clinical research enrollment data in near real-time (monthly).  Tracking real-time participant enrollment in NIA-funded trials/studies allows NIA to identify enrollment challenges and to ensure that NIA-funded trials/studies meet the requirements of NIH inclusion policies for Human Subjects. Data provided in CROMS also allows the Institute to ensure accountability and transparency in the responsible use of government funds. Further, CROMS has the capability to allow investigators to generate reports to meet requirements for annual NIH/NIA reporting. For more information on CROMS, please see NIA’s web page on the subject.

Policy

NIA requires the submission of a Corrective Action Plan (CAP) for clinical trials whose timeline milestones and participant enrollment indicate that the clinical trial is delayed, and the rate of enrollment is less than 60% of its expected benchmark. Such studies are substantially below acceptable levels for satisfactory progress (i.e., critical CROMS enrollment progress); therefore, NIA requires the principal investigator (PI) to provide a CAP for enrollment progress upon request.

The CAP must include all the following: 

1. A summary of the study's screening and enrollment history 
2. An assessment and explanation of the factors that are contributing to recruitment timeline delays
3. A plan detailing actions for remediation of the factors that are contributing to recruitment timeline delays
4. An overall timeline for correction 

The CAP must be signed by the PI and the Authorized Organization Representative (AOR) and be submitted to the NIA Program Official/Project Officer (PO). Additional guidance will be provided by NIA staff at the time of the request. Failure to provide a CAP within 2 weeks from the date of request may result in enforcement action as described in the NIH Grants Policy Statement. NIA will review and accept the CAP or request further input or modification. NIA staff will continue to monitor, provide support where applicable, and communicate with studies that have critical enrollment progress. Failure to make significant progress on the CAP may result in enforcement action as described in the NIH Grants Policy Statement.

This policy is effective immediately and applies to all NIA grants, contracts, and cooperative agreements that support  human subjects research and are required to electronically submit participant enrollment data into CROMS on a monthly basis, per NIA policy NOT-AG-23-017.

This policy does not supersede any NIH policy. The terms outlined above are in addition to, and not in lieu of, other NIH policies, including the PHS Human Subjects and Clinical Trials Information Form instructions regarding the Protection of Human Subjects attachment (Section 3.1) in the SF424 Application Guide and the Research Performance Progress Report (RPPR). 

This policy aims to ensure compliance with timely registration and clinical trial reporting which improves transparency and accountability and helps achieve recruitment and retention goals for studies focused on improving the health and well-being of older Americans.

Inquiries

Please direct all inquiries to:

Sharon L Smith, RN, DNP, CCRP
Chief, Clinical Operations and Support Branch
Office of Clinical Research
Division of Extramural Activities
National Institute on Aging (NIA)
Email: [email protected]