Last verified: August 16, 2026, against the NIH RPPR Instruction Guide (January 2026 edition), grants.nih.gov’s Inclusion of Women and Minorities policy page, and NIH Guide Notice NOT-OD-18-116. NIH forms and system screens change; re-check the grants.nih.gov Inclusion policy hub if you’re reading this more than a year later.
Planned vs. cumulative: the two Inclusion Enrollment Reports at a glance
Every NIH-defined clinical research study record carries up to two distinct Inclusion Enrollment Report (IER) tables in the Human Subjects System (HSS). They look identical — the same race-by-ethnicity-by-sex grid — but they’re completed at different points in the award lifecycle and edited through different workflows.
| Planned Enrollment Report | Cumulative (Actual) Enrollment Report | |
|---|---|---|
| When it’s completed | At application/Just-in-Time, before award, as part of the Study Record | At every Annual, Interim, and Final RPPR, for the life of the award |
| What it shows | The target study population you propose to enroll, by sex, race, and ethnicity | Actual participants enrolled to date, cumulative across all reporting periods |
| Where it lives | Study Record > Section 2 – Study Population Characteristics, in HSS | Same Study Record, same table — the “Cumulative” version of the grid |
| How you change it | Contact your Program Officer first; document the change in RPPR Section F.3.a before revising | Update directly with each RPPR; no PO sign-off required to update actuals |
| Who sees a submission error if it’s missing | N/A (required before award in most cases) | You — the RPPR system blocks submission if inclusion monitoring is required and no IER exists |
The rest of this guide walks through completing the Cumulative IER inside an RPPR — the recurring task that catches most research administrators off guard — and covers the Planned Enrollment Report where it differs.
What the Inclusion Enrollment Report is
The Inclusion Enrollment Report is the mechanism NIH uses to track compliance with its statutory requirement, under the Public Health Service Act § 492B (42 U.S.C. § 289a-2), to ensure women, racial and ethnic minority groups, and (since 2019) participants across the lifespan are appropriately represented in NIH-funded clinical research. For background on the underlying policy — what triggers it, what a compelling exclusion rationale looks like, and how it differs from the separate Inclusion Across the Lifespan policy — see CASRAI’s NIH Inclusion Policies dictionary entry. This guide covers the mechanics of completing the reporting form itself, not the underlying policy.
Two forms carry this information across the grant lifecycle:
- At application, the PHS Human Subjects and Clinical Trials Information Form captures the planned study population as part of each Study Record. See CASRAI’s PHS Human Subjects and Clinical Trials Information Form guide for the full application-stage form.
- In post-award reporting, the Inclusion Enrollment Report inside the Research Performance Progress Report (RPPR) captures actual, cumulative enrollment against that plan. That’s the focus of this guide.
Where to find it: Section G.4 of the RPPR
The IER isn’t a field you type into directly on the RPPR itself — it’s a linked record inside the Human Subjects System (HSS), reached from the RPPR. The path:
- Open your RPPR and go to Section G – Special Reporting Requirements.
- Save the RPPR first. The instruction guide is explicit on this: clicking through to HSS before saving Section G risks losing your work in that section.
- At question G.4 (Human Subjects), click the Human Subjects link. This opens the Application Information screen in ASSIST/HSS.
- Click the HSCT Post Submission tab. This lists every Study Record and delayed-onset record tied to the award.
- Click View on a study record to see its current IER, or click Edit (top of screen) to make changes, then Edit again in the Action column for the specific study record.
- Inside the Study Record, go to Section 2 – Study Population Characteristics. This is where the Inclusion Enrollment Report itself lives — you can add a new IER or edit an existing one from here.
For an NIH-defined clinical research study, reporting cumulative enrollment by sex, race, and ethnicity here is required, not optional — and if inclusion monitoring applies to your award and no IER exists, the RPPR system will not let you submit. For an FY that’s the current reporting year, this shows as a hard error; for a late progress report covering a past FY, it shows as a standing warning message on-screen and in the generated PDF.
The fields on the IER screen
Before you reach the enrollment count grid, the IER record itself asks for a small set of context fields:
| Field | What it captures |
|---|---|
| Using an Existing Dataset or Resource | Yes/No radio buttons — whether this study draws on a pre-existing dataset or resource rather than newly enrolled participants |
| Enrollment Location Type | Domestic or Foreign, by radio button |
| Enrollment Country(ies) | Selected from a dropdown list |
| Enrollment Location(s) | Free-text location detail |
| Comments | Optional free text for cumulative-enrollment context; pre-populated from any prior comments when you’re editing an existing IER |
If your study enrolls at both U.S. and non-U.S. sites, that’s not one IER — it’s two. NIH requires foreign-site enrollment to be reported on a separate Inclusion Enrollment Report from domestic-site enrollment, even when both are part of the same study.
Completing the enrollment count grid
Below the context fields sits the actual table: racial categories run down the left side, ethnic categories — split by sex — run across the top. Every intersecting cell is an editable count, defaulting to zero on a new IER and pre-populated with prior values when you’re editing an existing one. Row and column totals are calculated automatically by HSS and are not directly editable.
The categories follow the federal government’s standard race/ethnicity classification (OMB Statistical Policy Directive No. 15, revised 1997), which NIH uses so its data is comparable to Census and national health datasets:
| Ethnicity (2 categories) | Race (5 base categories, plus two aggregate categories) |
|---|---|
| Hispanic or Latino | American Indian or Alaska Native |
| Not Hispanic or Latino | Asian |
| Black or African American | |
| Native Hawaiian or Other Pacific Islander | |
| White | |
| More Than One Race (aggregate, for participants self-identifying with multiple categories) |
The table also carries dedicated Unknown/Not Reported fields for race, ethnicity, and sex — use those rather than guessing or omitting a participant. Two important collection rules from the NIH instruction guide, both easy to get wrong:
- The IER format is not a data-collection instrument. Collect sex/gender, race, and ethnicity from participants using your own study instrument (ideally two separate self-identification questions — ethnicity first, then race, allowing more than one racial selection), then aggregate into the OMB categories to populate the form. Participants who self-identify with more than one race are reported in the aggregate “More Than One Race” category, not split across individual race rows.
- For non-U.S. sites, design a culturally appropriate, self-identification data-collection instrument locally, then map results into the OMB categories for NIH reporting — the OMB categories themselves are not the instrument you hand participants.
Two ways to enter cumulative counts
You can populate the cumulative grid either of two ways:
- Edit cells online, directly in the existing IER.
- Download the Participant Level Data Template (a CSV) from the IER screen, fill it in at the individual-participant level, and upload it via the Upload Participant Level Data Attachment button — this populates the summary grid for you. A Download Current Participant Level Data button lets you retrieve what’s currently on file, and a Remove Current Participant Level Data button clears it if you need to start over.
For most currently active awards, the CSV upload isn’t optional. Per NIH Guide Notice NOT-OD-18-116, if the last competing application for the award was submitted for a due date on or after January 25, 2019, the recipient must report de-identified, individual-level participant data — sex/gender, race, ethnicity, and age at enrollment — using the spreadsheet template, for every subsequent RPPR. Manual cell entry into the summary grid is only available where that individual-level requirement doesn’t apply. Age can be reported in units from minutes to years, matching the study population.
Once you save changes, use the Save and Release Lock button to commit them (or Cancel and Release Lock to discard) — both return you to the Study Record list.
Handling multiple study records and multiple IERs
An award can have more than one Study Record, and a Study Record can have more than one Inclusion Enrollment Report over its life — each one must carry a unique title so program staff can tell them apart. If a new clinical study starts under the award and no Planned Enrollment record exists for it yet, create a new Planned Enrollment record in HSS before you can report cumulative actuals against it. All inclusion enrollment updates must be saved in HSS before you submit the RPPR — the system will warn you if data hasn’t been updated when you try to submit.
When actual enrollment doesn’t match the plan
If cumulative enrollment is falling short of, or otherwise diverging from, the planned distribution by sex, race, or ethnicity, that divergence and its reasons belong in narrative form in RPPR Section F.3.a (Human Subjects) — not just left implicit in the numbers. The same section is where you describe any change to the approved human-subjects protocol itself, and where you note that a new or revised Inclusion of Women, Minorities, and Children section and updated IER(s) are needed.
Changing the Planned Enrollment numbers themselves — as opposed to updating actuals — requires contacting your Program Officer first to discuss and agree the revision, documenting it in Section F.3.a, then revising the Planned Enrollment record in HSS. You cannot unilaterally revise what NIH approved as your enrollment target.
NIH-defined Phase III clinical trials: an additional layer
If the award involves an NIH-defined Phase III clinical trial, inclusion reporting carries an extra requirement on top of the IER grid: the RPPR’s Project Outcomes narrative must include a statement on the status of analyses of the primary outcome by sex and race/ethnicity (a “valid analysis”), and — where the trial also meets NIH’s definition of an Applicable Clinical Trial — the results of that valid analysis must additionally be reported to ClinicalTrials.gov. See CASRAI’s Clinical Trial Registration and Reporting Compliance guide for how ClinicalTrials.gov results reporting works alongside RPPR reporting.
AHRQ awards: a different path
Recipients of Agency for Healthcare Research and Quality (AHRQ) awards don’t use the HSS online grid at question G.4. Instead, where inclusion enrollment reporting is required, AHRQ recipients download and complete a Cumulative Inclusion Enrollment Report document and upload it directly in RPPR Section G.4. Where reporting isn’t required, select “Nothing to Report” instead.
Common mistakes that trigger program-officer follow-up
- Stale cumulative totals. Filing an RPPR with last year’s enrollment numbers rather than data updated through the current reporting period is one of the most common reasons program staff kick a report back.
- Uploading individual-level data when it isn’t required, or entering summary counts manually when individual-level upload is required. Check the competing application’s original due date against the January 25, 2019 threshold before choosing a method.
- Combining domestic and foreign enrollment on one IER instead of filing them as separate reports.
- Silent divergence from the planned distribution — leaving a sex/race/ethnicity shortfall unexplained instead of addressing it in Section F.3.a.
- Forgetting to save Section G before clicking through to HSS, which the instruction guide flags can cause you to lose unsaved work elsewhere in that section.
- Not creating a Planned Enrollment record for a newly added study before trying to report cumulative actuals against it.
Frequently asked questions
What is the NIH Inclusion Enrollment Report (IER)?
It’s the record inside NIH’s Human Subjects System that tracks a study’s participant population by sex, race, and ethnicity, in two forms: a Planned Enrollment Report set at application, and a Cumulative (Actual) Enrollment Report updated at every RPPR to show real enrollment against that plan.
Where do I find the Inclusion Enrollment Report in the RPPR?
In RPPR Section G – Special Reporting Requirements, at question G.4 (Human Subjects). Save Section G, click the Human Subjects link, open the HSCT Post Submission tab, and edit the Study Record’s Section 2 – Study Population Characteristics.
What’s the difference between the planned and cumulative enrollment report?
The Planned Enrollment Report is your target population, submitted at application and changeable only after discussing a revision with your Program Officer. The Cumulative (Actual) Enrollment Report is real enrollment to date, updated with every RPPR you file for the life of the award.
Do I have to upload a spreadsheet, or can I type counts in manually?
If the award’s last competing application had a due date on or after January 25, 2019, you must report de-identified, individual-level participant data (sex/gender, race, ethnicity, and age) via the CSV Participant Level Data Template, per NOT-OD-18-116. Older awards not subject to that requirement can use manual online cell entry into the summary grid.
What happens if I don’t complete the IER before submitting my RPPR?
If inclusion monitoring applies to your award and no IER exists for the current reporting year, the RPPR system blocks submission with an error. For a late progress report covering a prior fiscal year, a standing warning message appears on-screen and on the generated PDF instead.
Is the “Inclusion Enrollment Report” the same as a study’s inclusion/exclusion criteria?
No — these are unrelated NIH concepts that share a word. Inclusion/exclusion criteria define who is scientifically or clinically eligible to enroll in a study at all. The Inclusion Enrollment Report tracks the demographic composition (sex, race, ethnicity) of whoever does enroll, against NIH’s statutory representation policy. See CASRAI’s guide on defining inclusion and exclusion criteria for the eligibility-criteria concept.
Related CASRAI resources
- NIH Inclusion Policies (Women, Minorities, and Across the Lifespan) – the underlying policy this report implements
- NIH RPPR: How to Complete the Research Performance Progress Report – the full RPPR walkthrough this form sits inside
- NIH RPPR: A Worked, Filled-In Example
- NIH RPPR: Types, Sections, and Deadlines
- PHS Human Subjects and Clinical Trials Information Form – the application-stage counterpart to this post-award report
- The Human Subjects Section of an NIH Grant: A Worked Example
- Clinical Trial Registration and Reporting Compliance
- Inclusion and Exclusion Criteria: How to Define Who Is in Your Study
