Frequently Asked Questions about Recruitment Milestone Reporting (RMR)
1. Does my study need to report to RMR?
The NIMH Policy for the Recruitment of Participants in Clinical Research applies to all clinical research studies proposing to enroll 150 or more participants and all clinical trials, regardless of size.
- The policy does not apply to research projects consisting of multiple independent studies that enroll fewer than 150 participants separately and do not involve a clinical trial, yet may total 150 or more participants collectively.
- The policy does apply to collaborative studies for which each site proposes to recruit less than 150 participants, but collectively the sites will recruit 150 or more participants collectively.
2. How do I determine if my study is a clinical trial?
NIH defines a clinical trial as a research study1 in which one or more human subjects2 are prospectively assigned3 to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.5 For questions about whether or not NIMH considers your study to be a clinical trial, contact firstname.lastname@example.org.
3. Does the policy apply to research using existing datasets involving human subjects?
Generally, the NIMH Policy for the Recruitment of Participants in Clinical Research does not apply to studies with no prospective recruitment. Some exceptions apply; contact your NIMH Program Official if you are unsure if RMR is required.
Developing Recruitment Milestones
1. What should I consider when developing a recruitment timeline?
Time needed for start-up - It is rare for recruitment to begin the first day of the project period. Consider factors that may affect time needed to initiate recruitment, including adequate staffing and training, availability of equipment/supplies, institutional review board, and data safety and monitoring board approvals.
Rates of recruitment and retention – Consider historical rates of participation in studies with your team and/or at your institution. Also consider the size and diversity of your source population, the number likely to agree to participate, and the number who will actually be available for participation. Also consider how holidays, vacations and other seasonal events may impact recruitment over the course of the project.
Time needed for follow-up and analysis – Generally recruitment is expected to end well before the end of the project period. Consider how much time you will need to complete your study once all participants are enrolled, including follow-up with participants, cleaning and analyzing your data, and sharing results.
A reference document titled “Points to Consider about Recruitment and Retention While Preparing a Clinical Research Study” can assist Program Officials and Principal Investigators in discussions about recruitment strategies.
2. Are recruitment milestones cumulative?
Yes, the milestones should include all participants enrolled in the study as of the date of the milestone reporting period (e.g., for 25 new participants per reporting period, actual milestones should be entered in the following manner: April 1st: 25, August 1st: 50, December 1st: 75, etc.).
3. Can I plan for recruitment during a no-cost extension period?
NIMH expects recruitment to be completed well before the end of the funding period, with sufficient time for follow-up and analysis. Generally, there should be no recruitment within a no-cost extension period.
4. If my study involves more than one phase (e.g., R61/R33), for which phases should I set up my milestones?
Generally, milestones should reflect recruitment that will occur until the end of the project period, or until the next competing funding segment (whichever comes first). In the case of an R61/R33 study, initial milestones should only include recruitment that will occur in the R61 phase. Following submission of the R33 application, the investigator will establish milestones for the R33 phase.
5. How do I change my proposed targets?
With strong justification, investigators may request changes to the projected recruitment numbers and timetable after study initiation. Investigators are encouraged to discuss proposed changes in targets with their NIMH Program Official.
If significant changes to the overall number of subjects are proposed, investigators must submit changes for prior approval through the annual progress report or prior approval request.
A prior approval request must be submitted in writing (including email or via eRA Commons), addressed to the NIMH Grants Management Official listed in the Notice of Award, submitted no later than 30 days prior to the proposed change, and signed by the Institution’s Authorized Organization Representative (AOR). The request must be accompanied by:
- Scientific justification for the proposed change,
- Evidence the study will be able to achieve its specific aims, including a revised power analysis, if applicable, and
- If a reduction in participants is proposed, a revised budget identifying savings as a result of the reduction in recruitment.
1. Which participants should I include in my study’s recruitment milestones?
The overall target should reflect the total number of participants that will contribute to the primary analyses (e.g., in the case of a randomized clinical trial, this number typically reflects the number of participants who are randomized and contribute to intention-to-treat analyses and does NOT include screened or consented participants who fail to meet full inclusion criteria or are otherwise not randomized).
2. Should Hispanic subjects be included in the racial minority category?
It depends. As race and ethnicity are separate categories, participants identifying as Hispanic ethnicity also select one or more racial categories. For the purposes of the NIMH Policy on the Recruitment of Participants in Clinical Research, participants who identify as American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, or More Than One Race should be included in the racial minority category regardless of ethnicity.
For more information about racial and ethnic categories used for NIH and other federal reporting see NOT-OD-15-089.
3. I am conducting research outside the U.S. and the racial and ethnic minority groups are different than the U.S. Which participants do I include in the racial minority category?
The racial categories used for NIH reporting are developed by the Office of Management and Budget and are defined for the U.S. population. For the purposes of the NIMH Policy on the Recruitment of Participants in Clinical Research, racial minority is defined as individuals identifying as Black/African American, American Indian or Alaska Native, Native Hawaiian or Pacific Islander, Asian, or More Than One Race, regardless of the individual’s minority status in the context of the study location. Investigators conducting research outside the U.S. may find it helpful to refer to the racial category definitions.
For additional information about collecting and reporting racial and ethnic data for NIH studies recruiting participants outside the U.S., see the NIH Grants & Funding FAQs for Inclusion on the Basis of Sex/Gender, Race, and Ethnicity.
Using the RMR System
1. How do I create an RMR Record?
To create an RMR record, follow the steps below:
- Go to the NIMH Recruitment Milestone Reporting site at: http://wwwapps.nimh.nih.gov/rmr/.
- Use your eRA Commons username and password to login.
- Select the “Recruitment Reporting and Review” tab.
- Create a recruitment milestone report by entering the grant serial number, and selecting “Load Grant Data.”
- Select the appropriate grant.
- Check the project details displayed and select "Create."
- On the next page, enter your projected cumulative target total, racial minority, and Hispanic enrollment for each milestone date of the project period.
- You may enter comments in the "Action Commons" box. When completed, select "Submit to PO."
2. I am unable to login to RMR. What should I do?
Only the Contact Principal Investigator (PI) assigned to a study is authorized to access the RMR record. If you are the Contact PI and are unable to login, try clearing your browser cache or using a different browser. You can reset your eRA Commons username and password at https://public.era.nih.gov/ams/public/accounts/password/reset.era?menu_itemPath=90902. Current or former NIMH employees and others who have difficulty accessing RMR after following these steps should contact email@example.com for assistance.
3. Can I create more than one record for my project in RMR?
Yes, RMR allows multiple records to be associated with one project. To create more than one record, follow the steps for creating an RMR record above and assign a unique title to each record.
4. How do I assign a delegate to assist with managing my RMR records?
You may assign a delegate by navigating to the "Manage Delegation" section on the "My Account" tab. Delegates assigned to a Principal Investigator account must have an eRA Commons account. The delegate will have access to all of your assigned RMR records and will be able to perform the same functions in the system (e.g., create and edit records, submit target and actual data).
Delegates will not receive system notifications. However, you may choose to set up an auto-forwarding rule using your email software. Contact your IT team for assistance.
5. I have an award assigned to multiple Principal Investigators and would like all investigators to have access to RMR.
By default, only the Contact Principal Investigator associated with the study has access to RMR. You may assign other investigators as delegates using the "Manage Delegates" feature explained above, but only the Principal Investigator listed in RMR will receive system notifications for the RMR record. To change the Principal Investigator contact firstname.lastname@example.org.
6. I entered my recruitment numbers but my Program Official tells me they haven’t been received. What should I do?
Make sure you select "Submit to PO." Your numbers may be saved, but your Program Official will not be able to review until you select this option.
7. How do I revise my study’s recruitment start and/or end date?
Contact your NIMH Program Official to discuss changing your study’s start and/or end date. To change the recruitment start and/or end date access your RMR record and click the “Update Details” button. Enter your new start/end date and save. You can only change your start or end dates in the RMR system prior to beginning recruitment. If recruitment has begun, contact email@example.com to request these dates be changed.
8. How do I change my recruitment milestones in RMR?
Contact your NIMH Program Official to discuss changing your milestones. With Program Official approval, you can change milestone targets by expanding the RMR Project Details Box and selecting “Revise Targets.” If changing recruitment start and end dates, see instructions above. You will not be able to change your recruitment milestones if there are any reporting periods pending review by your NIMH Program Official.
9. The system will not allow me to enter actual recruitment data for the reporting period I am trying to enter. What should I do?
The deadline for submission may have passed. Contact firstname.lastname@example.org for assistance.
Who can I contact for help?
For questions about use of the RMR system or the NIMH Policy for the Recruitment of Participants in Clinical Research, contact email@example.com. To discuss your study’s recruitment plan or performance, contact your NIMH Program Official.
1 See Common Rule definition of research at 45 CFR 46.102(d).
2 See Common Rule definition of human subject at 45 CFR 46.102(f) .
3 The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.
4 An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.
5Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.