NIA’s Clinical Research Operations & Management System (CROMS)
Accelerating access to real-time clinical research enrollment and inclusion data
The Clinical Research Operations and Management System provides NIA staff and grantees real-time tracking, reporting, and management of clinical research enrollment data, study documents, and activities.
NIA Announces Policy and Procedures Update for CROMS
NIA recently issued a policy update that provides additional guidance on compliance procedures for reporting human subjects enrollment data using NIA’s Clinical Research Operations and Management System (CROMS). The 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 CROMS for all human subjects enrolled in their trials. We are writing to encourage you to review this guidance carefully.
The updates include:
- Ensuring that Informed Consent Documents list NIH as one of the organizations that may review or receive copies of information in participants’ study records
- Reporting the assigned National Clinical Trial number in CROMS within three months of assignment
- Performing quarterly reviews of your CROMS study record(s)
- Ensuring that final enrollment data reported in CROMS are consistent with the data reported in ClinicalTrials.gov
Since the signing of the National Alzheimer’s Project Act (NAPA), NIA has significantly increased funding for research on Alzheimer’s disease and related dementias (AD/ADRD). To provide a more efficient and seamless research experience, NIA developed the Clinical Research Operations and Management System (CROMS). CROMS tracks, reports, and manages extramural clinical research enrollment data, study documents, activities, and portfolios in real time across NIA clinical research projects.
What is CROMS?
CROMS is NIA's Clinical Research Operations & Management System. It provides NIA staff and grantees with near real-time monthly tracking, reporting, and management of clinical research enrollment data, study documents, and activities. Each CROMS study record collects standardized information for all NIA-funded clinical trial aims and enrollment.
Improving Clinical Trial Reporting, Recruitment, and Retention
One of the biggest hurdles in advancing AD/ADRD research is participant recruitment and retention in clinical studies, particularly among underrepresented populations. Tracking real-time participant enrollment in NIA-funded studies through CROMS will allow NIA to intervene early to help with enrollment challenges.
When Can I Start Using CROMS?
CROMS will eventually be used by all grantees with NIA grants supporting human subjects research.
Currently, NIA is working with investigators of NIA-funded clinical trials to submit enrollment data into CROMS. To determine if your NIA-funded clinical trial is required to report into CROMS, please review the document “CROMS Use Decision Tree" found at the CROMS Resource List.
If you are an investigator with an active NIA-funded clinical trial and have not heard from the CROMS team, please email NIAClinicalResearch@nia.nih.gov at your earliest convenience with the subject line, “Should my trial be in CROMS: [your NIA grant number]”.
What Participant Enrollment Information Do I Need to Provide to CROMS?
You can find a list of required Enrollment File and Screening File data elements collected in CROMS in the Resources section of the CROMS website.
If you were awarded a study after June 30, 2021, you need to provide data for ALL the data fields listed. If you are not collecting one or more of the data fields specified in this template, you will need to request an exemption. Please submit your request for exemption in writing to NIA CROMS Support: NIACROMSsupport@niacroms.org with the subject line “Data Element Exemption Request: [your NIA grant number]”.
Get More Information on CROMS
Visit NIA CROMS Resources for the following documents:
- Decision Tree: Determine Your CROMS Requirements
- Your Trial’s Lifecycle in CROMS
- CROMS FAQs
- CROMS Study Record Instructions
- CROMS Enrollment File Instructions
- CROMS Screening and Enrollment Templates
If you have any questions or comments on how CROMS can help you and your research, contact NIAClinicalResearch@nia.nih.gov.