.png)
Understanding the Fundamentals of Good Clinical Practice
A practical, participant-focused introduction to ICH E6(R3), Quality by Design, risk-based thinking, data governance, and real-world GCP decision-making.
About This Course
The Good Clinical Practice (GCP) – ICH E6(R3) course provides an in-depth understanding of the international ethical and scientific quality standards for designing, conducting, recording and reporting clinical trials. You will learn how to apply GCP principles in real-world scenarios and understand responsibilities at all key stakeholders in clinical research.
Learning Outcomes
- Understand the key principles of ICH E6(R3)
- Recognise roles and responsibilities in clinical trials
- Apply GCP guidelines to real-world scenarios
- Identify and manage risks, safety and compliance issues
Course Curriculum
Managing Investigational Products in Accordance with GCP Requirements
A practical, risk-based introduction to the investigational product lifecycle: roles and responsibilities, packaging and blinding, shipment and storage, temperature excursions, dispensing, accountability, and final disposition.
Monitoring Clinical Trials by Sponsors
A practical, risk-based introduction to sponsor oversight: monitoring approaches, the monitoring plan, site visits, noncompliance management, essential records, and record retention.
Sponsor Responsibilities and Good Clinical Practice
A practical introduction to the sponsor's role across the trial lifecycle: quality by design, risk-based quality management, delegation and oversight, investigator selection, investigational product responsibilities, safety oversight, and multicenter/international coordination.
Administrative Documents and Essential Records
A practical guide to protocols, protocol amendments and deviations, Investigator’s Brochures, essential records, document control, electronic records, and retention.
Audits and Inspections of Clinical Trials
A practical, risk-based guide to clinical trial audits, regulatory inspections, inspection readiness, inspection conduct, findings, responses, CAPA, data integrity, and regulatory follow-up.
Detection, Evaluation, and Reporting of Adverse Events
A practical, participant-focused guide to recognizing adverse events, evaluating seriousness, severity, causality and expectedness, documenting safety information, managing serious events, and applying regulatory reporting requirements.
Informed Consent in Clinical Trials
A practical, participant-focused guide to the informed consent process, required information, documentation, re-consent, vulnerable participants, remote and electronic consent, waivers, and real-world GCP decision-making.
IRB / IEC / REB — Comprehensive Training Module
A detailed training module covering independent ethical review, responsibilities, composition, quorum, review pathways, submissions, continuing oversight, vulnerable populations, protocol amendments, safety information, decentralized research, records, communication, and inspection readiness.
INVESTIGATOR RESPONSIBILITIES AND GOOD CLINICAL PRACTICE
A detailed training module covering investigator qualifications, feasibility, resources, delegation and oversight, participant protection, informed consent, investigational product management, protocol compliance, safety reporting, data integrity, essential records, ethics communication, study conduct, termination, and inspection readiness.
Advance Your Career in Clinical Research
Gain the skills and certification you need to make an impact in global healthcare.