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Diversity, Equity and Inclusion in Clinical Trials Course & Certification
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Updated 2026
3 hours
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Each course includes:
eBook
Access the course content in eBook format, which can be downloaded and read on your device.
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with a position that is genuinely moving: the commencement status of the United States diversity action plan duty at section 505(z), which depends on a final guidance that has not been published and does not appear on the CDER guidance agenda for 2026; the June 2024 draft guidance, removed from fda.gov in early 2025 and restored by court order; OMB Statistical Policy Directive No. 15 as revised in March 2024, whose implementation deadlines have slipped twice, most recently on 27 March 2026; the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, SI 2025/538, in force since 28 April 2026 and containing no representativeness provision; NIHR research inclusion as a condition of funding for opportunities opening from 27 November 2024; the Health Research Authority Inclusion and Diversity Plan, whose pilot has closed and which is not mandatory; the ACT EU workplan for 2026 and 2027; and ICH E6(R3), E7, E9(R1) and the draft E21.
Learn from Industry Experts
The content is written by practitioners in clinical development and research governance, and is built directly on primary sources: the Food and Drug Omnibus Reform Act of 2022 and section 505(z) of the Federal Food, Drug, and Cosmetic Act, FDA guidance and its Report to Congress on diversity action plans, the Drug Trials Snapshots programme, SI 2025/538 and the Government consultation response that explains it, NIHR INCLUDE and the INCLUDE Ethnicity Framework, Health Research Authority guidance, the Equality Act 2010, Regulation (EU) 536/2014, ACT EU, the ICH guidelines, OMB Statistical Policy Directive No. 15 and the Office for National Statistics census classification, and named published studies on representation, eligibility criteria and pharmacogenomic difference. Every requirement taught names its instrument and its legal status, every figure names the study it comes from, and the course states plainly which widely repeated statistics could not be traced to an authoritative source.
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About
Diversity, Equity and Inclusion in Clinical Trials training provides the knowledge and practical skills required to design, conduct, and oversee clinical trials that are representative, inclusive, and accessible to the populations intended to benefit from the investigational product. Learners gain an understanding of the scientific, ethical, regulatory, and operational principles that support equitable participant selection, inclusive study design, representative recruitment strategies, and the reduction of barriers to participation across diverse populations.
This Diversity, Equity and Inclusion in Clinical Trials Course & Certification covers trial representativeness, inclusion planning, participant recruitment and retention, under-served populations, demographic data collection, eligibility criteria assessment, site selection, community engagement, decentralised trial considerations, subgroup analysis, regulatory expectations, and global guidance from FDA, ICH, HRA, NIHR, and EU frameworks. Upon successful completion, learners receive a certification demonstrating their understanding of diversity, equity, inclusion, representativeness, and inclusive clinical trial design and conduct.
Who Should Enrol?
- Clinical Research and Clinical Operations Professionals
- Principal Investigators, Study Coordinators, and Research Nurses
- Regulatory Affairs and Compliance Professionals
- Biostatistics and Data Management Professionals
- Quality Assurance and GCP Professionals
- Pharmaceutical, Biotechnology, CRO, and Life Sciences Professionals
What you will learn
Understand the principles of diversity, equity and inclusion (DEI) in clinical trials and their importance in generating evidence that is relevant to the populations who will ultimately use medicinal products.
Learn how to design, plan and conduct inclusive clinical research by addressing barriers to participation, representative participant selection, eligibility criteria, site selection, recruitment strategies, retention, and community engagement.
Develop knowledge of global regulatory expectations and guidance from the FDA, MHRA, HRA, NIHR, ICH E6(R3), ICH E8(R1), ICH E7, and the EU Clinical Trials Regulation, including diversity plans, inclusion frameworks, and under-served populations.
Gain understanding of demographic data collection, race and ethnicity standards, socioeconomic measures, subgroup analyses, decentralised trial considerations, and the interpretation of diversity-related evidence.
Course Syllabus
- Representation is a generalisability problem before it is anything else
- The United States duty: live in statute, dormant in effect
- The United Kingdom choice of guidance over legislation
- Race is a poor proxy for ancestry, and no substitute for a genotype
- Eligibility criteria do most of the excluding
- The fictional Ashcombe Therapeutics case study
- 1.1 The argument, stated precisely
- 1.2 Documented differences by ancestry
- 1.3 Documented differences by sex
- 1.4 Where the claim has been overstated
- 1.5 Under-representation relative to disease burden
- 2.1 The statute: FDORA and section 505(z)
- 2.2 What a diversity action plan must contain
- 2.3 The commencement problem
- 2.4 The earlier framework, still current
- 2.5 What to do while the duty is dormant
- 3.1 Guidance rather than legislation
- 3.2 NIHR INCLUDE and the funding condition
- 3.3 The HRA route
- 3.4 The Equality Act and the public sector duty
- 3.5 What the clinical trials regulations do not say
- 4.1 What the Clinical Trials Regulation actually says
- 4.2 Specific populations in EU guidance
- 4.3 ACT EU and the European workplan
- 4.4 The ICH layer that reaches all three regions
- 4.5 Running one programme across three regions
- 5.1 Under-served is study-specific, not a fixed list
- 5.2 Ethnicity, mistrust and the historical harms
- 5.3 Sex, pregnancy and lactation
- 5.4 Age, frailty and multimorbidity
- 5.5 Disability, mental illness and learning disability
- 5.6 Deprivation, geography and language
- 6.1 Eligibility criteria as the primary mechanism
- 6.2 Justifying or removing each criterion
- 6.3 Site selection as an exclusion mechanism
- 6.4 Visit burden, travel and time
- 6.5 Decentralisation and the digital counter-risk
- 6.6 Building it into the protocol, not a separate document
- 7.1 Self-identification as the collection standard
- 7.2 Two categorisation standards that do not map
- 7.3 Sex assigned at birth and gender identity
- 7.4 Socioeconomic position and geography
- 7.5 Missing, not stated and categories that cannot be pooled
- 7.6 Reporting enrolment demographics
- 8.1 Description and inference are different acts
- 8.2 Multiplicity, power and the harm of over-claiming
- 8.3 Pre-specification, estimands and ICH E9(R1)
- 8.4 When a difference reaches the product label
- 8.5 Metrics that show whether inclusion worked
- 8.6 Ownership, flow-down and accountability that lasts
- The decision points, in the order they arise on a programme
- The eight recurring failures and the control that prevents each
- Assigned ownership rather than assumed ownership
- A system, not a commitment
- Keeping pace with requirements that are genuinely moving
- Course completion
- 📘 Bonus: Diversity, Equity and Inclusion in Clinical Trials eBook (Free with purchase)
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Frequently Asked Questions
- Clinical Research, Clinical Operations & Study Management Professionals
- Regulatory Affairs, Ethics & Research Governance Professionals
- Principal Investigators, Research Nurses & Clinical Site Teams
- Patient Engagement, Recruitment & Community Outreach Teams
- Pharmaceutical, Biotechnology & Medical Device Professionals
- CROs, Sponsors, Quality Assurance & GCP Compliance Professionals
This module builds a foundational understanding of diversity, equity, and inclusion (DEI) in clinical trials, focusing on representative participant selection, inclusive study design, equitable recruitment, and reducing barriers to participation. This module covers regulatory expectations, demographic data, under-served populations, recruitment strategies, and inclusive trial practices to support ethical, scientifically robust, and generalisable clinical research.
- Developed by clinical research, regulatory, ethics, and GCP experts
- Practical, real-world focus aligned with global clinical trial diversity and inclusion expectations
- Covers inclusive trial design, representative recruitment, under-served populations, and participant engagement
- Suitable for professionals across pharmaceuticals, biotechnology, CROs, medical devices, and clinical research
- Designed to support ethical research, regulatory readiness, equitable participation, and generalisable clinical evidence
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