Corrective Action Plans (CAPs) for Enrollment Progress

The NIA has instituted the NIA Clinical Research Enrollment Policy (NOT-AG-24-081) to address NIA clinical trials with participant enrollment progress indicating that the clinical trial is delayed and may not be completed on time.

This policy applies to all NIA grants, contracts, and cooperative agreements that support human subjects research that are required to electronically submit participant enrollment data into the secure NIA Clinical Research Operations & Management System (CROMS) on a monthly basis, per NIA Update to Policy and Procedures for the Reporting of Human Subjects Enrollment Data for NIA Clinical Research Trials/Studies (NOT-AG-23-017) , and is effective immediately.

NIA staff monitor participant accrual on an ongoing basis using CROMS. 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. This places the study substantially below acceptable levels for satisfactory progress (i.e., ‘critical’ CROMS enrollment progress).

The CAP will include the following:

• Summary of screening and enrollment history of study
• Assessment and explanation of factors contributing to recruitment timeline delays
• Identify planned actions for remediation of these factors
• Overall timeline for correction

CAP Submission and Follow up:

• The CAP must be signed by the Principal Investigator (PI) and Authorized Organization Representative (AOR) and be submitted to the NIA Program Official/Project Officer (PO) within 2 weeks from the date of request.
• NIA will review and either accept the CAP or request further input or modification.
• NIA staff will continue to closely monitor, provide support where applicable, and communicate with studies that have critical enrollment progress or other progress concerns.

This CAP is an ongoing process for improvement of clinical trial enrollment and progress that may have budget implications, require a revised Notice of Grant Award, and/or result in evaluation of the study’s feasibility to continue.

This policy aims to ensure compliance with timely clinical trial enrollment progress 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.

The CAP is a process to support investigators in developing plans to enhance their recruitment strategies and improve study progress, while ensuring effective stewardship of NIA research investments to meet approved study goals in a timely manner.

The NIA Clinical Research Enrollment Policy (NOT-AG-24-081) is effective immediately.

For questions about corrective action plans, contact Dr. Sharon Smith at sharon.smith@nih.gov or connect with NIA’s Office of Clinical Research at NIAClinicalResearch@nia.nih.gov .