Key Dates

Related Announcements

NOT-AG-23-017 - Update to Policy and Procedures for the Reporting of Human Subjects Enrollment Data for NIA Clinical Research Trials/Studies

Issued by

National Institute on Aging (NIA)

Purpose

The purpose of this Notice is to inform the research community of the National Institute on Aging (NIA) new policy and procedures for reporting enrollment data for clinical research trials/studies funded through an NIA funding mechanism (including grants, contracts, and cooperative agreements). This Notice details the new requirements, expectations of NIA-funded investigators, and impetus for the policy change.

Policy Requirements

The new policy applies to all NIA grants, contracts, and cooperative agreements that are active as of July 1, 2021 and support human subjects research as defined by the National Institutes of Health (NIH). In addition to NIH reporting requirements for study enrollment, NIA investigators will be required, on a monthly basis, to electronically submit participant enrollment data into the secure NIA Clinical Research Operations & Management System (CROMS) for all human subjects enrolled in their trials/studies. As well, all new Funding Opportunity Announcements (FOA), Notices of Awards (NoA), and Terms of Agreements (ToA) will include the following language:

The National Institute on Aging (NIA) supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. This resource, the Clinical Research Operations Management System (CROMS), is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary.

Investigators will have the following three options for transferring enrollment data into NIA’s CROMS:

1. File transfer (one-time Excel template setup and subsequent monthly upload using the Excel file)
2. Web portal entry (manually enter data monthly through a secure NIA CROMS web portal)
3. System-to-system transfer (one-time setup with investigator/organization system to push data automatically to CROMS)

NIA is in the final stages of developing CROMS. Although CROMS will eventually be used by all NIA investigators with NIA awards supporting human subjects research, NIA is using a staggered approach to register investigators in CROMS and begin collecting enrollment data monthly. The stages are as outlined:

• Stage 1 Investigators with grant awards that support Alzheimer’s disease and related dementias (AD/ADRD) clinical trials
  • NIA is defining clinical trials using NIH’s definition
  • Enrollment data entry for clinical trials in Stage 1 will take place in two waves:
    • Wave 1 will begin July 1, 2021
    • Wave 2 will begin September 1, 2021
  • Investigators in Stage 1 will receive an email by June 15, 2021 informing them of:
    • The policy change
    • Their assigned wave
    • The process they will be expected to follow (in their assigned wave) to submit enrollment data for their eligible trial(s)
  • Instructions and a help desk will be available to awardees throughout this process

• Stage 2 Investigators with grant awards that support clinical trials that are not categorized as AD/ADRD
  • Enrollment data entry for clinical trials in Stage 2 will begin November 1, 2021
  • Investigators in Stage 2 will receive an email by September 1, 2021 informing them of the policy change and their anticipated timeline to begin the enrollment submission process

• Stage 3 Investigators with grant awards that support all other clinical studies that enroll human subjects
  • NIA is defining clinical research studies using NIH’s definition
  • Enrollment data entry for clinical studies in Stage 3 will begin March 1, 2022
  • Investigators in Stage 3 will receive an email by January 1, 2022 informing them of the policy change and their anticipated timeline to begin the enrollment submission process

Policy Motivation/Impetus

NIA, one of the 27 Institutes and Centers (ICs) of the 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.

One of the biggest hurdles in advancing aging research is participant recruitment and retention into NIA-funded clinical trials/studies, particularly among diverse and traditionally underrepresented populations. Tracking real-time participant enrollment in NIA-funded trials/studies through CROMS will allow NIA to identify enrollment challenges and to ensure that NIA-funded trials/studies meet the requirements of NIH inclusion policies. CROMS will provide NIA a more efficient and seamless ability to manage the enrollment performance of its clinical research portfolio, allowing the ability to track, report, and manage extramural clinical research enrollment data, study documents, activities, and portfolios in real time.

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). CROMS has the capabilities to allow investigators to generate reports and inclusion enrollment reports to meet requirements for annual NIH/NIA reporting. For more information on CROMS, please see NIA’s blog post and NIA’s announcement.

Inquiries

Please direct all inquiries to:

Holly Massett, Ph.D.
Senior Advisor, Clinical Research Recruitment & Engagement
Division of Extramural Activities
National Institute on Aging
Email: NIAclinicalresearch@nia.nih.gov