Introduction
Clinical trials are essential for advancing medical knowledge and improving patient care. However, without proper understanding and application of Good Clinical Practice (GCP), research can compromise patient safety, data integrity, and regulatory compliance.
Many professionals involved in clinical research are not fully equipped with the practical knowledge of global GCP standards, which can lead to ethical risks, errors, and delays in clinical trials.
This course is designed to equip participants with the knowledge and confidence to conduct and manage clinical trials responsibly. It focuses on protecting participant rights, ensuring accurate and reliable data, and maintaining compliance with both international and South African regulatory requirements.
By completing this course, participants will strengthen their ability to contribute to ethical, high-quality clinical research and improve overall trial outcomes.
Accreditation
Accredited according to the HPCSA’s Medical and Dental Board Guidelines for Healthcare Professionals for 19 CEUs on Level 2.
Certification
Participants will receive a Certificate of Completion on successful completion of the course, subject to full attendance and achieving a minimum of 70% on the assessment.
Course Dates
| Date |
Venue |
| 18 – 19 June 2026 |
FPD Knowledge Park, Gauteng |
Assessment
Participants are assessed through a multiple-choice questionnaire on the last day of the course.
A minimum pass mark of 70% is required.
Course Content
- Introduction to Good Clinical Practice
- Ethical Considerations in Clinical Research
- Regulatory Requirements
- Study Design
- Investigator Responsibilities
- Sponsor Responsibilities
- Essential Documents and Records
- Protocol Design
- Informed Consent
- Participant Recruitment and Selection
- Participant Medical Care and Safety Reporting
- Data Governance and Quality Management
Course Design
This course is delivered as an interactive in-person workshop.
The learning approach includes expert-facilitated content, practical tools, case studies, engaging presentations, and guided discussion to support understanding and application of Good Clinical Practice principles in clinical trials.
Study Material
- Expert-facilitated content from leading professionals in Good Clinical Practice.
- Engaging presentations.
- A comprehensive manual.
- Case studies.
- Practical tools.
Who Should Enrol
Clinical research associates, study coordinators, investigators, ethics committee members, regulatory professionals, and anyone involved in planning, conducting, or monitoring clinical trials.
If you want to ensure ethical, compliant, and high-quality clinical trials, protect participant safety, and strengthen your credibility in research, this course is for you.