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.
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 is developing the Clinical Research Operations and Management System (CROMS). CROMS will track, report, and manage extramural clinical research enrollment data, study documents, activities, and portfolios in real-time across NIA clinical research projects.
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.
If you are an NIA grantee enrolling human subjects, you can look forward to the following benefits of CROMS:
- Generate reports/inclusion enrollment tables formatted to meet requirements for annual NIH/NIA reporting (with no double entry of data).
- Set up and receive automatic reminders related to NIA grant activities, like approaching deadlines, study milestones, and enrollment milestones. It will automatically track progress in one system, reducing the need to track by email.
- Access tools and visualizations to monitor and compare planned and actual participant enrollment for each study and across your portfolio.
- View study-specific data and documents shared with NIA in one central system (e.g., participant enrollment data, investigator information, site information, and final study documents).
- Receive information on best practices around enrollment and retention that have been identified and summarized through CROMS.
When Can I Start Using CROMS?
NIA is currently in the early stages of developing CROMS. CROMS will eventually be available to all NIA grantees with NIA grants supporting human subjects research. NIA will use a phased approach to register grantees in CROMS during the early stages as outlined below.
- Stage 1: Investigators with grants that support AD/ADRD clinical trials
- Stage 2: Investigators with grants that support non-AD/ADRD clinical trials
- Stage 3: Investigators with grants that support all other clinical studies that enroll human subjects
What Participant Enrollment Information Do I Need to Provide to CROMS?
Tracking real-time participant enrollment in NIA-funded studies through CROMS will allow NIA to intervene early to help with enrollment challenges. To ensure consistency in reporting, NIA has developed a core set of data elements for grantees to provide information related to participants – those that are enrolled in studies, and those that have failed the screen.
The NIA CROMS Enrollment Data Elements file (PDF, 188K) and the NIA CROMS Screen Failure Data Elements file (PDF, 296K) are stand-alone, quick reference documents that list and explain the data elements that are to be provided on a monthly basis to the CROMS system.
The NIA CROMS Enrollment template file (PDF, 317K) and the NIA CROMS Screen Failure template file (PDF, 315K) allow you to quickly create a pre-formatted file that will be easily uploaded into the system once you add your data. Each template includes all columns for all the required data elements, as well approved values that can be selected for specific data elements. Each file contains a tab that lists and explains the data elements and one with answers to some frequently asked questions.
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.
CROMS’ 2021 Focus—NIA-Funded AD/ADRD Clinical Trials
Given the urgency of AD/ADRD research, our initial focus for CROMS in Fiscal Year 2021 will be for those grants supporting AD/ADRD clinical trials. Investigators with an active AD/ADRD clinical trial should have received an email from the CROMS team in December 2020 with a request to complete an online questionnaire. This questionnaire aims to assess the specific type of enrollment data and processes that NIA grantees track for their trials and learn of grantees’ preferences regarding how to interact with CROMS after its development.
If you are an investigator with an active AD/ADRD clinical trial and have not received an email with the questionnaire link, please email NIAClinicalResearch@nia.nih.gov at your earliest convenience. We want to ensure your trial and preferences are taken into account as we begin the CROMS-grantee data exchange in Spring 2021.
Get More Information on CROMS
We are currently in the early stages of developing CROMS. In the near future, we will likely be reaching out directly to our grantees who have grants supporting non-AD/ADRD clinical trials.
In the meantime, keep an eye out on this website for updates for our stakeholders and research community regarding the development and rollout of CROMS. If you have any questions or comments on how CROMS can help you and your research, contact NIAClinicalResearch@nia.nih.gov.