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Clinical Research Courses

Clinical research refers to the scientific investigation conducted on human subjects to evaluate the safety, efficacy, and effectiveness of new medical treatments, interventions, drugs, devices, or diagnostic procedures. It plays a crucial role in advancing medical knowledge, improving patient care, and developing new therapies.

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Medical research involving human subjects is strictly controlled by the South African Health Products Regulatory Authority (SAHPRA); DOH and Ethics Committees.

Whether you are a healthcare professional, researcher, or industry professional involved in clinical trials, these courses will equip you with the necessary knowledge and skills to conduct ethical and compliant clinical research. By the end of the courses, you will have a solid understanding of the ethical considerations, regulatory requirements, and best practices for conducting clinical trials involving human participants in South Africa.

GCP Basic for Clinical Staff

This course introduces the essential ethical and scientific standards for conducting clinical trials, based on SA GCP 2020. It also covers key frameworks, including ICH E6(R3) and the Ethics in Health Research (2024) guidelines, equipping clinical staff with the foundational knowledge needed for ethical and compliant research.

GCP Refresher

This refresher course strengthens and updates participants’ understanding of Good Clinical Practice in line with SA GCP 2020. It reviews key principles, regulatory updates, and guidelines such as ICH E6(R3) and the Ethics in Health Research (2024), helping experienced research staff stay current and compliant.

GCP Basic for Support Staff

This course provides non-clinical staff with a clear introduction to the ethical principles and standards guiding clinical trials, based on SA GCP 2020. It includes an overview of ICH E6(R3) and the Ethics in Health Research (2024) guidelines to help support staff understand their role in maintaining ethical and compliant research operations.

ABC of Quality Management

This practical course will equip clinical research site personnel with the relevant knowledge and tools to ensure successful study conduct from start to finish, in preparation for monitoring audits and site inspections.

Clinical Research Coordinator

The Clinical Research Coordinator Course provides practical training on coordinating and managing clinical trials, covering recruitment, consent, investigational product handling, data management, and site documentation. Participants gain the skills to ensure ethical, compliant, and high-quality study operations, from start-up to close-out, while developing teamwork and leadership abilities.

Ethics in Health Research

The Ethics in Health Research Course offers a clear introduction to the ethical principles and processes that guide health research in South Africa, based on the Ethics in Health Research (2024) guidelines. It covers key topics such as informed consent, data protection, ethics committee roles, and emerging issues like digital health and data sharing.