FDA Diversity Action Plan Compliance: What Clinical Research Sites Need to Know Now

Clinical research sites running Phase 3 trials are navigating one of the most significant regulatory shifts in a generation. The FDA Diversity Action Plan (DAP) requirement — mandated by the Food and Drug Omnibus Reform Act of 2022 (FDORA) — isn't a future concern. Sponsors are already using DAP-readiness as a site selection criterion. Sites without pre-compliance infrastructure are losing contracts now, before the final enforcement window even opens.

Here's what the requirement actually means, what sites need to do, and how to build the infrastructure that protects your contracts and competitive position.

What Is the FDA Diversity Action Plan Requirement?

The FDA Diversity Action Plan requirement was written into law through FDORA (the Food and Drug Omnibus Reform Act of 2022), specifically under Sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act.

The statute requires sponsors of certain pivotal drug, biologic, and device studies to submit a DAP to the FDA. These plans must specify:

• →Enrollment goals by demographic group (race, ethnicity, age, sex, and other relevant characteristics)
• →The rationale for those goals, grounded in the disease population the therapy targets
• →Concrete plans for monitoring enrollment diversity during the trial
• →Strategies for achieving those goals if enrollment falls behind

Important context for 2025: In January 2025, the Trump administration's DEI executive orders prompted FDA to temporarily remove the draft DAP guidance from its website. That guidance was restored by court order on February 11, 2025. As of May 2026, the statutory obligation to submit DAPs remains fully in effect — executive orders cannot override Congressional law. The regulatory uncertainty is around timing and implementation details, not whether DAPs are required.

For sites: the exact enforcement trigger is in flux. But sponsors are not waiting for the final guidance to start vetting sites on diversity infrastructure. The practical enforcement is happening now, at the contract level.

What Sites Actually Need to Do

The DAP requirement is a sponsor obligation — but it's a site problem. Here's why: sponsors submit DAPs, but they select sites based on whether those sites can deliver on them.

A site that can't demonstrate diversity enrollment capability is a liability to a sponsor's DAP. That site doesn't get selected. Or worse: the site gets selected, fails to meet diversity milestones mid-trial, and faces protocol amendments — which run $500,000 or more and delay the entire program.

What compliance-ready sites need to have in place:

1. Demographic Data Tracking at the Patient Level

This is the foundation. Sites need to capture race, ethnicity, age, sex, and other demographic fields — accurately, consistently, and in a format that maps to both CTMS systems and sponsor reporting requirements. Not checkbox diversity data gathered at consent and never revisited. Real-time, longitudinal tracking through the enrollment funnel.

Most sites currently track enrollment numbers. Compliant sites track who is being enrolled, why others are screened out, and what the demographic gap is versus the protocol's enrollment goals.

2. Enrollment Metrics Tied to Diversity Goals

A DAP isn't just a plan — it's a performance commitment. Sites need enrollment dashboards that show current demographic breakdown vs. target enrollment goals, screening-to-enrollment conversion rates by demographic group, dropout and retention rates by demographic group, and timeline projections. Sponsors ask for this data during site qualification visits. Sites that can pull it in real time win contracts. Sites that have to scramble to generate a retrospective spreadsheet don't.

3. Pre-Screened Patient Access in Underrepresented Communities

Reaching underrepresented populations isn't a marketing problem — it's an infrastructure problem. Sites need established community partnerships, not cold outreach campaigns launched when a trial opens. The sites winning diverse enrollment contracts have relationships with community health centers, faith organizations, and patient advocacy groups in the specific communities they need to reach, trusted navigator or community health worker programs to reduce participation barriers, and bilingual intake and follow-up workflows. You cannot build this in 90 days when a trial opens. You build it before the trial, so it's ready to activate.

4. Audit-Ready Documentation

If a sponsor's DAP is reviewed by FDA, the sponsor needs to demonstrate that enrollment diversity goals are being met — or show documented good-faith efforts and corrective actions. That documentation lives at the site level. Audit-ready sites have IRB-approved recruitment protocols that explicitly address diversity outreach, records of community partnership activities and outreach campaigns, enrollment diversity data with timestamps and screening data, and documented rationale when diversity targets aren't met in a given window. None of this is burdensome if you've built the systems. All of it is impossible to reconstruct after the fact if you haven't.

The Common Gaps at Phase 3 Sites

Sites running complex Phase 3 trials are often the least prepared for DAP compliance — not because they don't care, but because they've been optimizing for enrollment speed over enrollment diversity. Those two goals used to feel like a tradeoff. Under the DAP framework, they're the same goal.

Why Pre-Compliance Infrastructure Is a Competitive Moat — Not Just a Regulatory Checkbox

Here's the business case that matters to site leadership: sponsors are selecting sites on DAP-readiness before DAP is formally enforced.

This isn't speculation. It's observable in how site qualification visits and sponsor due diligence have evolved. Sites are being asked directly:

• →"What is your current demographic enrollment breakdown across active trials?"
• →"Describe your community outreach strategy for underrepresented populations."
• →"How do you track and report diversity metrics during the trial?"

Sites that can answer these questions credibly — with real data, real partnerships, real infrastructure — get added to sponsor preferred site lists. Sites that can't are being passed over, even when they have strong enrollment track records in other areas.

5 Steps Sites Can Take Now to Prepare for DAP Enforcement

These are actionable — not aspirational. Each one can be implemented now, before the final FDA guidance is published, and each one makes your site more competitive for sponsor contracts today.

1. 1
   Audit your current diversity data infrastructure. Pull the last 12 months of enrollment data across active trials. What demographic fields are you capturing? Where are the gaps? Are you tracking dropout and retention by demographic group? This baseline is the foundation for every other step. You can't fix what you can't see.
2. 2
   Build or activate three to five community partnerships in your target demographics. Identify which communities are underrepresented in your current enrollment relative to your market's disease prevalence. Map the organizations those communities trust — community health centers, patient advocacy groups, faith institutions, community health workers. Start the relationship before the trial opens. Outreach that begins when a trial is already recruiting is six months too late.
3. 3
   Implement real-time diversity tracking in your enrollment workflow. Your coordinators should not have to generate a diversity report manually. The data should be visible at any point during the trial, by protocol, by demographic target, against the DAP goals. If your current CTMS can't do this natively, you need a layer that can — and it needs to integrate without adding coordinator burden.
4. 4
   Create audit-ready documentation protocols now. Define what documentation gets created at each step of the recruitment process for diverse populations: community outreach records, screening data, rationale for screen failures, corrective action plans when diversity targets lag. Build the documentation habit before the trial opens, not after FDA starts asking for it.
5. 5
   Train coordinators on DAP requirements — and reduce their reporting burden. Your coordinators are the execution layer. They need to understand what DAPs require and why it matters. But more importantly: every diversity reporting requirement that doesn't require coordinator manual entry is a win. Invest in automation wherever the workflow allows. Coordinator retention is already the industry's number one operational problem — adding unfunded mandate energy to diversity compliance will accelerate burnout, unless the infrastructure reduces the burden rather than adding to it.