A Diversity Action Plan (DAP) is the enrollment plan FDORA requires for most pivotal drug trials and device IDE studies: goals for age, sex, race and ethnicity, the sponsor's rationale for those goals, and how the sponsor plans to meet them. This guide covers what is actually required today and how an EDC supports tracking enrollment against it.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Site risk
Site 03 needs attention
Action items
2 overdue
2022
FDORA created the statutory Diversity Action Plan requirement
4
demographic categories a DAP sets goals for: age, sex, race, ethnicity
Phase 3
or other pivotal study, is generally when a drug DAP applies
By-site
enrollment filtering and export, already in Capture
The requirement
The Food and Drug Omnibus Reform Act of 2022 (FDORA) added a statutory requirement that sponsors of certain clinical studies submit a Diversity Action Plan to FDA: a document setting enrollment goals for the trial's target population by age group, sex, race and ethnicity, the sponsor's rationale for those goals, and the plan for meeting them. For drugs, this generally applies to a Phase 3 study or other pivotal clinical study; for devices, it goes in the IDE application.
| SUBJ | ECGPERF_CODE | ECGPERF_LABEL |
|---|---|---|
| 01-001 | Y | Yes |
| 01-002 | ND | Not done |
Where the guidance stands
This is the part that actually moves, so confirm it directly before you finalize a plan.
FDORA's DAP requirement is law; it has not been repealed.
FDA published revised draft guidance on DAP format and content on June 26, 2024, and said compliance would begin 180 days after a final version is published.
FDA removed the draft guidance from its website without public explanation, reported in July 2026, following an executive order on federal DEI policy. Final guidance and an effective date are not confirmed as of this writing.
Confirm current requirements directly with FDA or regulatory counsel before finalizing a DAP; do not rely on this page as your compliance source.
The EDC side
Capture does not have a button labeled Diversity Action Plan. What it has are the underlying pieces most sponsors actually use to track enrollment against DAP-style goals: demographic fields captured through standard question types at screening, by-site data filtering, and CSV/Excel exports you can cut by whatever field you captured.
Start screening
Screen new subject
Not screened before
Rescreen subject
Needs a new screening number
ICF date
14-Sep-2026
Year of birth
1971
Sex
Female
Before you switch
Demographic question types, by-site filtering and exports are part of every plan, including the free sandbox.
Capture does not verify or certify a DAP's content. It gives you the enrollment data and by-site views to support building and tracking one; confirm final DAP requirements with FDA or regulatory counsel.
Demographic fields are standard question types, added the same way as any other CRF field.
Bring an existing study's enrollment tracking across without losing history.
Email support, typically under 24 hours, plus documentation on Enterprise.
Free sandbox with every feature. No credit card, no sales call.
A DAP is the enrollment plan FDORA requires for many pivotal drug trials and device IDE studies: goals for age, sex, race and ethnicity, the rationale behind them, and how the sponsor plans to meet them.
The statutory requirement from FDORA (2022) has not been repealed. FDA's implementing draft guidance was removed from its website in 2026, so confirm current requirements directly with FDA or regulatory counsel.
No. Capture provides demographic question types, by-site filtering and exports that support tracking enrollment against DAP-style goals, not a labeled DAP module.
Generally, a Phase 3 or other pivotal drug study, or a device study under an IDE application, per the FDORA statute. Check current FDA guidance for exact thresholds and any exceptions.
It was removed from FDA's website without public explanation, reported in July 2026, following an executive order on federal DEI policy. The status of a final guidance is unconfirmed as of this writing.
Capture demographic fields with standard question types at screening, then use by-site filtering and CSV/Excel exports to check enrollment against your stated goals.
Yes. The free sandbox includes every feature with sample data, no credit card required.
Keep exploring
Multi-site clinical trial management
The by-site enrollment views a DAP tracking approach builds on.
Clinical operations software
A cross-site status dashboard for enrollment oversight.
FDA Expedited IND Pilot Program guide
Another live FDA regulatory change to plan around.
CRF builder for clinical trials
How demographic fields get added to a form.
21 CFR Part 11 compliance checklist
The audit trail behind every enrollment record.
Free sandbox with every feature. No credit card, no sales call.