Extended refresher GCP
What We Cover
In line with SA GCP 4.3.3.10, a GCP refresher is required every three years. The 3rd Edition of the NDoH Ethics in Health Research also mandates that all healthcare professionals and students involved in research receive ethics training.
With recent regulatory updates—including ICH GCP E6(R3), the Declaration of Helsinki, and the NDoH Ethics in Health Research—there is a clear need for updated refresher training. Afrileadtech offers a 16-hour advanced refresher programme to ensure clinical research professionals remain compliant and well-equipped.
Please note that ICH GCP R3 becomes effective on 01 July 2025.This training is available virtually or as a hybrid programme and is tailored for individuals who have already completed SA GCP version 3 (2020).
Course highlights:
Updated WMA Declaration of Helsinki
All clinical trials must align with the foundational principles of the Declaration of Helsinki. Updated in 2024, it now includes 37 ethical principles. This training introduces learners to these principles, ensuring ethical compliance across all health research professionals—not just physicians.
ICH GCP E6(R3)
The ICH GCP E6(R3), effective from 01 July 2025, introduces updated principles for modern clinical trial conduct. This training covers its 13 core principles, focusing on data integrity, participant safety, and sponsor responsibilities, ensuring research professionals comply with evolving global standards for ethical, quality-driven research.
Updated NDoH Ethics in Health Research, 3rd Edition
The 2024 NDoH Guidelines require all REC members, administrators, researchers, and students involved in human or animal research to complete theoretical research ethics training. This ensures they are familiar with ethical expectations and regulatory requirements for conducting responsible and compliant health research. (Section 5.4)
Accreditation & Certification
Training cost
R4,500.00
Accreditation
16 CPD ethics points
Assessment
Final assessment requires an 80% pass mark to receive certification.
Registration
Secure your place by completing the order and registration process at:
Dr Nyeleti Bicky Mthombeni (PhD)—an HPCSA-accredited trainer with over 18 years of experience in clinical research and more than a decade in GCP content development and training.
info@afrileadtech.co.za
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