GCP Foundations

A comprehensive training programme fully aligned with ICH E6(R3) (Step 4, 2025), covering the ethical, regulatory, and operational foundations of Good Clinical Practice. Suitable for initial GCP certification and for professionals with prior E6(R2) training seeking to understand what has changed.

8 Modules

Approx. 8-10 hours

Certificate on completion

English & German

Foundation

Self-paced · Start any time Access: 2 months from start date Last updated: Q2 2026

What This Course Covers

Good Clinical Practice (GCP) is the international quality standard that governs every aspect of clinical trial conduct — from the ethical framework underpinning participant protection to the operational requirements for data integrity, safety reporting, and regulatory oversight. This course provides a comprehensive, ICH E6(R3)-aligned foundation in GCP for all professionals involved in clinical trial planning, conduct, monitoring, and oversight.

Across eight modules, the programme covers the historical and ethical basis of GCP, the ICH E6(R3) regulatory framework, the responsibilities of sponsors, investigators, and CROs, protocol adherence and deviation management, ALCOA++ data integrity principles, adverse event and SUSAR reporting, risk-based monitoring, and essential document management and inspection readiness. Each module includes an applied scenario and a gated knowledge check, and the course concludes with a 20-question final assessment.

The course is aligned with ICH E6(R3) as adopted at Step 4 (2025) and is designed to satisfy the TransCelerate Mutual Recognition Program (MRP) minimum training criteria for ICH GCP investigator site personnel. It is suitable both for initial GCP certification and for professionals previously trained under ICH E6(R2) who need to understand the changes introduced in E6(R3). Both FDA and EMA regulatory frameworks are addressed throughout.

Who Is Ready for This Course

No prior GCP training is required. The course is designed for participants encountering clinical trial governance for the first time as well as for those seeking to formalise or update existing knowledge in line with ICH E6(R3). Module 1 provides the necessary regulatory and historical context before introducing GCP requirements. A basic familiarity with the pharmaceutical industry or healthcare environment is helpful but not essential.

After Completing This Course

01 Explain the historical development of GCP from the Nuremberg Code through ICH E6(R3), describe how the guideline becomes legally enforceable across FDA, EMA, and PMDA jurisdictions, and identify the key changes introduced in E6(R3) relative to E6(R2).

02 Describe the required elements of informed consent under ICH E6(R3), apply the principles governing re-consent following protocol amendments, and evaluate the regulatory and ethical considerations for eConsent and consent in decentralised clinical trials.

03 Differentiate the regulatory obligations of sponsors, investigators, and CROs under ICH E6(R3), explain the limits of delegation and the principle of retained ultimate sponsor accountability, and apply the delegation framework to common clinical trial staffing scenarios.

04 Distinguish between substantial and non-substantial protocol amendments under EU CTR 536/2014, classify protocol deviations by potential impact on participant safety and data integrity, and design a CAPA response appropriate to a given deviation type and root cause.

05 Apply the ALCOA++ principles to evaluate the completeness and compliance of paper and electronic trial records, identify common data integrity deficiencies in regulatory inspections, and explain the requirements for electronic records and audit trails under FDA 21 CFR Part 11 and EU GMP Annex 11.

06 Classify adverse events and serious adverse events using ICH E6(R3) criteria, determine whether a suspected adverse reaction is expected or unexpected against the Investigator's Brochure, and apply the expedited reporting timelines for SUSARs under FDA and EMA requirements.

07 Describe the principles of risk-based quality management (RBQM) as defined in ICH E6(R3), distinguish between source data verification (SDV) and source data review (SDR), and explain the role and regulatory accountability of the clinical research associate (CRA) in on-site and remote monitoring.

08 Identify the essential documents required before, during, and after a clinical trial under ICH E6(R3), explain the complementary roles of the sponsor Trial Master File (TMF) and the Investigator Site File (ISF), and apply best practices for TMF management and regulatory inspection readiness.

8 Modules · 10 Applied 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. All modules reflect the updated guideline, including its strengthened emphasis on quality by design, risk-based approaches, and fit-for-purpose monitoring. If you have previously trained under ICH E6(R2), the course explicitly highlights where requirements have changed — making it equally suitable for initial GCP certification and for experienced professionals transitioning from E6(R2).

Foundations — Why GCP Exists, the ICH E6(R3) Framework & Regulatory Geography

Historical basis · ICH E6(R3) Step 4 (2025) · Regulatory landscape · Case study · Knowledge check

Ethics & Informed Consent — Principles, Process & Modern Adaptations

Consent elements · Re-consent · eConsent · Decentralised trials · Case study · Knowledge check

Roles & Responsibilities — Sponsor, Investigator, CRO & Site

Delegation · Accountability · Dual perspective · Case study · Knowledge check

Protocol Adherence — Amendments, Deviations & CAPA

Substantial amendments · Deviation classification · Root cause analysis · CAPA · Case study · Knowledge check

Data Integrity, Records & ALCOA++

ALCOA++ principles · Audit trails · 21 CFR Part 11 · EU Annex 11 · Case study · Knowledge check

Safety Reporting — AEs, SAEs, SUSARs & Reporting Timelines

AE/SAE classification · SUSAR · Causality · Expedited reporting · Case study · Knowledge check

Monitoring — Risk-Based Quality Management, SDV/SDR & the CRA Role

RBQM · Central monitoring · SDV vs SDR · CRA duties · Case study · Knowledge check

Essential Documents, TMF & Inspection Readiness

Essential documents · TMF vs ISF · Inspection conduct · Case study · Knowledge check · Course summary

Final Assessment

20-question quiz · Covers all 8 modules · 80% pass mark · Certificate on passing

Who This Course Is For

WELL SUITED FOR

Life sciences graduates and career changers entering clinical trial functions who require initial GCP certification
Investigator site staff — study coordinators, research nurses, sub-investigators — seeking a structured GCP foundation aligned with ICH E6(R3)
Sponsor and CRO personnel including CRAs, CTMs, clinical operations staff, and regulatory affairs professionals involved in clinical trial conduct
Professionals previously trained under ICH E6(R2) who need to understand the changes introduced in E6(R3) — including updated risk-based quality management requirements, revised monitoring expectations, and new quality by design principles

NOT DESIGNED FOR

Professionals seeking a 24-month GCP renewal — the separate GCP in Practice (Refresher) course is designed for that purpose
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 Foundations), completion date, ICH E6(R3) alignment, and the Bradford Hill Academy seal.

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 with a specific professional body depends on that body's policies.

Frequently Asked Questions

I have no prior GCP training — is this course suitable for me?

Yes. The course is designed for participants with no prior GCP knowledge. Module 1 provides all the historical and regulatory context needed before the GCP requirements are introduced. A basic familiarity with the pharmaceutical or healthcare environment is helpful but is not required to follow the content.

Does this course satisfy TransCelerate MRP requirements?

This course is designed to cover the five minimum content domains identified by TransCelerate for ICH GCP investigator site personnel training: trial conduct, participant safety, informed consent, safety reporting, and data integrity. The certificate explicitly states ICH E6(R3) alignment. Whether a specific provider's certificate qualifies for MRP mutual recognition is determined by each sponsor company — verification with your organisation is recommended.

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. Contact enterprise@bradfordhillacademy.com for a quote. Custom GCP training programmes adapted to your organisation's SOPs or specific trial types can also be discussed.

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

One retake is permitted after a 24-hour cooldown period. If a second attempt is also unsuccessful, a review with a course instructor or LMS administrator is required before further access is granted. Participants can revisit any module before reattempting. The pass mark is 80% (16 out of 20 questions).