Good Clinical Practice (GCP) ICH E6 (R3)

Description

Good Clinical Practice (GCP) Training 

Course Overview

This online GCP compliance training course will help you understand ICH standards such as ICH’s E6 (R3) and E8 for Clinical Trials, including Good Clinical Practice (GCP) R3 requirements, trial approval processes, adverse event reporting, and stakeholder responsibilities.

It includes information on compliance with the latest Good Clinical Practice (GCP) ICH E6 (R3) guidelines (adopted in January 2025) as well as regional guidance examples from the US FDA, EC/EMA, UK MHRA and Australian TGA.

Why complete this course? This online Certificate GCP (R3) Training Course will help you understand Sponsor & Investigator responsibilities, GCP compliance standards, ethics/clinical trial approval processes, regulatory oversight, and related legal requirements for conducting high-quality clinical trials to ensure robust and reliable clinical trial data, while safeguarding participants.

The GCP compliance training course covers the following topics:

✅ Drug Development Stages (Phases I to IV) (pre-clinical investigations and clinical stages of drug development)
✅ Clinical trial planning and essential documentation – Trial design considerations and Informed Consent requirements (ICF/PICF components)
✅ Clinical Trial Applications (submission requirements to HRECs or IRBs, clinical trial protocols, recruitment materials, pre-clinical data)
✅Clinical Trial Approval processes (Ethics Committee processes/approvals, role of Regulatory Authorities and DSMBs)
✅ ICH E6(R3) – ICH E6 Good Clinical Practice (GCP) Guidelines
✅ ICH E8(R1) – Key items outlined in ICH E8 – General Considerations for Clinical Trials (ICH Guidelines)
✅ Quality by Design (QbD) and identifying Critical-to-Quality Factors (CtQ)
✅ Participant safety monitoring
✅ Regulatory Requirements – Examples from Regulatory Authorities including EMA, FDA, MHRA, TGA and others
✅ Sponsor & Principal Investigator Responsibilities – Key obligations to meet compliance requirements
✅ Data Governance responsibilities – audit trails and clinical trial reporting

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This self-paced Good Clinical Practice (GCP) R3 online training course is designed for professionals involved in the planning, conduct, monitoring, or oversight of clinical trials in hospitals, research institutions, or industry settings. It is suitable for a variety of clinical trial personnel roles and responsibilities. It is an intensive online training course which can be accessed for 12 months from the date of purchase or assignment by your Supervisor. You can stop and start this course over several days if required, and successful completion of the online Final Assessment will provide you with a GCP Training Certificate of Completion.

Who should take this course? This GCP compliance training course is suitable for Sponsors, Investigators, Clinical Trial Personnel, Clinical Research Organisations (CROs), medical teams, data analysts, clinical trial pharmacists, Regulatory Authority inspectors/site inspectors, Quality Managers, Human Research Ethics Committee (HREC) members, Data Safety Monitoring Board (DSMB) members, validation personnel, clinical trial database managers and report writers, and other key clinical trial stakeholders.

Benefits of this Certificate GCP (R3) Training Course

What you’ll gain by completing this GCP compliance course based on ICH E6 (R3) and E8:

• Solid understanding of GCP principles – Learn the internationally recognised ethical and scientific standards that ensure the rights, safety, and well-being of trial participants and measures to ensure the quality and reliability of clinical trial data.
• Role-specific guidance – Understand your responsibilities within the trial process, whether you’re a Sponsor, Investigator, Ethics Committee member, or part of the monitoring or regulatory compliance team.
• Practical compliance skills – Learn how to apply GCP requirements in real-world trial situations, from informed consent to data integrity and risk management.
• Regulatory readiness – Be prepared for audits, inspections, and compliance checks by knowing exactly what regulators expect.
• Flexible learning – Study at your own pace, revisit materials anytime, and apply the knowledge directly to your current or future projects.

By the end of the course, you will feel more confident in applying GCP principles in your role, contributing to the ethical conduct, data quality, participant safety monitoring, and regulatory compliance of the clinical trials you support.

Other suggested courses include PIC/S GMP01, PIC/S GMP02, PIC/S Annex 1 (Sterile Manufacturing), PIC/S Annex 16 (Authorised Persons & Batch Release), Annex 13 (Investigational Medicinal Products or ‘IMPs’), and more.

 

We offer over 70 GMP/GxP industry courses for compliance with industry regulations and standards including from PIC/S, FDA, TGA, EU EMA, UK MHRA, other regulators, and ISPE & ISO standards! For course details, click on the ‘store‘ menu item.

Flexible Online Learning Format

This self-paced eLearning course allows participants to:
✔️ Access course materials 24/7 after purchase (valid for 12 months)
✔️ Complete the training at their own pace with practical case studies (the average course completion timeframe is listed below)
✔️ Combine online learning with instructor-led training options (virtual or onsite, where available)

 

This course will help you understand Good Clinical Practice (GCP) requirements for Clinical Trials as part of the drug development process. Topics range from planning a study to submitting a Clinical Trial Application to a Human Research Ethics Committee or Independent Review Board (IRB) or Regulatory Authority, to incorporating quality by design principles and risk-based approaches, data integrity measures, participant selection/exclusion criteria, participant safety monitoring/reporting, and more. This course is based on ICH Guidelines for Clinical Trial, with a focus on E6(R3) and E8(R1) of the ICH efficacy guidelines for clinical trials, and is suitable for a global audience.

Good Clinical Practice: GCP Training Certificate Course

• Successful completion of the Final Assessment awards a downloadable/printable Certificate of Completion.
• This Certificate should be added to your Clinical Trial/personnel training records, and attach it to your CV when you apply for any job openings in drug development, clinical research, and/or pharmaceutical manufacturing.
• Note: This course meets requirements for Mutual Recognition GCP Investigator Site training programs.

Need an affordable way to boost your Clinical Trials personnel training and regulatory compliance training programs?

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