GCP in Practice (Refresher)

A condensed, ICH E6(R3)-aligned refresher built for the 24-month GCP renewal cycle. Rather than re-teaching the basics, it goes straight to where GCP principles are actually tested in practice — consent edge cases, data integrity and safety reporting, deviation management and CAPA — and closes with an integrated applied case running across three connected decision points.

5 Modules

Approx. 4-5 hours

Certificate on completion

English & German

Foundation

Self-paced · Start any time Access: 90 days from start date Last updated: Q3 2026

What This Course Covers

GCP in Practice (Refresher) is built for professionals who already hold a working knowledge of Good Clinical Practice and need to renew or update it within the standard 24-month cycle. It does not re-teach GCP from first principles — it assumes that foundation and goes directly to the areas where it is most frequently tested in day-to-day trial conduct.

Across five modules, the programme delivers a condensed review of core GCP principles and what has changed under ICH E6(R3), consent edge cases including vulnerable populations, emergency research, and digital consent, ALCOA++ data integrity applied alongside AE/SAE/SUSAR safety reporting timelines, deviation classification and CAPA built from actual EMA and FDA inspection finding patterns, and a closing module of integrated applied case scenarios covering sponsor, investigator, and CRO accountability and risk-based monitoring. The course concludes with a 20-question final assessment.

The course is aligned with ICH E6(R3) as adopted at Step 4 (2025) and reflects its current regulatory status across the EU, Switzerland, and other ICH jurisdictions. It is designed as the 24-month renewal companion to GCP Foundations, and both FDA and EMA regulatory frameworks are addressed throughout.

Who Is Ready for This Course

This course assumes prior GCP training — either Bradford Hill Academy's GCP Foundations course or an equivalent programme — and practical experience working within a clinical trial environment. It is built as a renewal, not an introduction: content moves directly to edge cases, applied scenarios, and what has changed since your last training, without re-explaining foundational concepts such as the basic elements of informed consent or the roles of sponsor, investigator, and CRO. If you have not previously completed GCP training, start with GCP Foundations instead.

After Completing This Course You Will Be Able To:

01 Summarise the core GCP framework at speed, identify the substantive changes introduced by ICH E6(R3) relative to E6(R2) — including quality by design and critical-to-quality factors — and state the current adoption status of E6(R3) across FDA, EMA, and Swissmedic.

02 Apply informed consent principles to the situations where they are most frequently tested — minors and incapacitated adults, emergency research without prior consent, and eConsent and remote consent under ICH E6(R3) Annex 2.

03 Apply the ALCOA++ principles in the safety-reporting context, distinguish AEs, SAEs, and SUSARs, and explain how a data-integrity gap can itself delay recognition of a reportable safety signal.

04 Classify deviations as critical, major, or minor in line with current EMA and FDA inspection finding patterns, distinguish root cause from symptom, and build a CAPA response that targets the underlying cause rather than the individual finding.

05 Distinguish the non-transferable accountability of sponsors, investigators, and CROs, apply risk-based monitoring logic to a multi-region trial, and work through an integrated case spanning oversight, data integrity, and decentralised trial elements.

5 Modules · Applied Case Scenarios · Final Assessment

Updated for ICH E6(R3) — Step 4 Adoption (2025)

This course is fully aligned with ICH E6(R3), adopted at Step 4 in 2025. Each module reflects the current adoption status across FDA, EMA, and Swissmedic, and highlights where E6(R3) requirements differ from the E6(R2) approach most learners trained under originally.

Core GCP Principles — Condensed Review & E6(R3) Changes

Framework recap · E6(R2) to E6(R3) changes · Quality by design · Regulatory status · Applied scenario · Knowledge check

Consent, Ethics & Participant Protection — Scenarios & Edge Cases

Consent essentials at speed · Vulnerable populations · Emergency consent · eConsent under Annex 2 · Knowledge check

Data Integrity & Safety Reporting — Recap and Applied Practice

ALCOA++ at speed · AE/SAE/SUSAR distinctions · Two reporting clocks · Where data integrity meets safety signals · Knowledge check

Deviations, Inspection Findings & CAPA — Lessons from Real Findings

Critical/major/minor classification · What EMA and FDA inspectors actually find · Root cause vs symptom · Building durable CAPA · Knowledge check

Applied GCP — Three Integrated Case Scenarios

Sponsor/investigator/CRO accountability · Risk-based monitoring in practice · Multi-region integrated case · Course summary · Knowledge check

Final Assessment

20-question quiz · Covers all 5 modules · 80% pass mark · Certificate on passing

Who This Course Is For

WELL SUITED FOR

Professionals renewing GCP certification within the standard 24-month cycle
Investigator site staff, CRAs, CTMs, and clinical operations personnel who previously completed GCP Foundations or an equivalent course and need a condensed, applied update
Sponsor and CRO staff who want a fast, scenario-driven check of how ICH E6(R3) is applied in practice, rather than a full re-run of first principles

NOT DESIGNED FOR

First-time learners with no prior GCP training — start with the GCP Foundations course, which builds the framework this refresher assumes
Those seeking training on GMP, GDP, or GLP — this course covers GCP only; separate programmes address other quality standards
Regulatory affairs professionals focused exclusively on submissions or post-marketing activities without involvement in clinical trial conduct

Certificate of Completion

Bradford Hill Academy — Certificate of Completion

Issued digitally upon passing the 20-question final assessment (80% minimum). The certificate states: participant name, course title (GCP in Practice — Refresher), completion date, ICH E6(R3) alignment, and the Bradford Hill Academy seal, and can be used to support a 24-month GCP renewal cycle.

Bradford Hill Academy certificates are professional development certificates. They are not issued by or on behalf of a state-recognised academic institution and do not confer academic degrees or formal qualifications. Whether a certificate qualifies for CPD recognition or satisfies a specific employer's renewal requirement depends on that body's policies.

Frequently Asked Questions

I completed GCP Foundations — is this the right course to renew?

Yes. This course is designed as the direct 24-month renewal companion to GCP Foundations. It assumes that foundational knowledge and focuses on applied edge cases, current inspection finding patterns, and what has changed under ICH E6(R3) since you last trained.

How is this different from GCP Foundations?

GCP Foundations builds the full framework from first principles across eight modules. This refresher assumes that framework and, across five shorter modules, moves straight to edge cases, applied scenarios, current inspection finding patterns, and regulatory developments since E6(R3) adoption — without re-explaining concepts covered in Foundations.

How quickly is the content updated when ICH E6 guidance changes?

Course authors monitor FDA, EMA, and ICH publications on an ongoing basis. When a new guidance document or regulatory update materially affects course content, the relevant module is updated, the review date is revised, and enrolled learners who have accessed that module are notified by email.

Can this course be licensed for a team or organisation?

Yes. Team and enterprise licensing is available from 5 licences upward, with volume-based pricing and a central administration dashboard for tracking progress and certificate status across your team. Contact info@bradfordhillacademy.com for more information. Custom renewal cycles or content adapted to your organisation's SOPs can also be provided.

What happens if I don't pass the final assessment?

Two retakes are permitted (three attempts in total). Participants can revisit all modules before reattempting. The pass mark is 80% (16 out of 20 questions).