This online course will help you understand industry guidelines and your responsibilities in conducting high-quality clinical trials, while safeguarding participants through proper selection, informed consent, and ongoing monitoring.
The course covers the following topics:
✅ Drug Development stages (pre-clinical investigations and clinical stages of drug development) ✅ Clinical Trial Applications (submissions requirements, clinical trial protocol, recruitment materials, pre-clinical data)
✅Clinical Trial Approval processes (HREC, IRBs, Regulatory Authorities, DSMBs) ✅ ICH E6(R3) – Good Clinical Practice (GCP) Guidelines
✅ ICH E8(R1) – General Considerations for Clinical Trials (ICH Guidelines)
✅ Regulatory Requirements – Examples from Regulatory Authorities including EMA, FDA, MHRA, TGA and others
✅ Sponsor & Principal Investigator Responsibilities – Key obligations to meet compliance requirements
✅ Phases I to IV of Clinical Trials – Design considerations and Informed Consent requirements
✅ Quality by Design (QbD) and Critical-to-Quality Factors ✅ Participant safety monitoring
✅ Data Governance responsibilities – audit trails and clinical trial reporting
This self-paced online Good Clinical Practice (GCP) 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 Sponsors, Investigators, trial personnel, medical teams, data analysts, quality managers, clinical trial pharmacists, regulatory authority staff, site inspectors, Human Research Ethics Committee (HREC) members, Data Safety Monitoring Board (DSMB) members, and other key clinical trial stakeholders.
Benefits of this Certificate GCP Course
What you’ll gain by completing this GCP compliance course:
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 the reliability of 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 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.
Who Should Take This Good Clinical Practice (GCP)Course (online)?
This online GCP training course is essential for individuals working with Clinical Trials and trial data/reporting information, including but not limited to
✅ Pharmaceutical & Biotech Manufacturers and Sponsors of new drug applications ✅ Principal Investigators and their clinical trial team members / personnel
✅ Contract Facilities & Pharmaceutical Service Providers ✅ Clinical Research Organisations (CROs)
✅ Quality Assurance (QA) & Regulatory Affairs (RA) Professionals
✅ Validation, Process & Engineers for Clinical Trial Data Systems ✅ Clinical Trial Database Managersand data entry personnel ✅ Medical professionals, Clinicians, Nursing teams, Pharmacists
✅ Ethics Committee Members
✅ Participant Safety & Compliance Officers
✅ Clinical Trial Site Inspectors & Auditors
✅ …and more!
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 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, and is suitable for a global audience.
Good Clinical Practice: GCP – 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.
Need an affordable way to boost your Clinical Trials personnel training and regulatory compliance training programs?
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