Welcome to Our Comprehensive Good Clinical Practise (GCP) Training
What We Cover
Our GCP training encompasses a wide array of critical topics, including:
ICH GCP R2: Stay updated with the latest revisions and requirements set by the International Council for Harmonisation.
South African Good Clinical Practise: Understand the Clinical Trial Guidelines version 3 2020, ensuring your trials adhere to national standards.
Ethics in Health Research: Delve into the Principles, Processes, and Structures as per the Department of Health (DOH) 2015 guidelines, fostering a strong ethical foundation for your research journey.
Online GCP Training
A comprehensive 16-hour session covering the fundamental principles of Good Clinical Practice By the end of this module, participants will have earned 16 CPD points, enhancing their professional development. Cost: R2200 per participant.
On-Site GCP Training
We offer the flexibility of conducting the training both on-site and off-site. Scheduled GCP dates will be available under "Upcoming Events". Cost: R2950.00 per participant. Should you want to book us to visit you at your facility, make a booking by contacting nyeleti@afrileadtech.co.za
Refresher GCP
Keep your knowledge current with our Refresher GCP, available as a half-day event or online module. Stay updated and ensure your skills remain sharp! Booking: Interested in this module? Cost: R1250.00
Course Outline
Origins & history of Good Clinical Practise
Sponsor - Responsibilities
Regulatory Authority
Informed consent Process
Ehics in clinical research
Investigator responsibilities
Essential Documents
Source Data Collection and Reporting
Quality Assurance and Quality Control
Accreditation & Certification
Upon finishing the program, participants will earn 16 Ethics points (16 hours of training), as it
officially accredited by the SAMA CPD Committee for HPCSA registered medical professionals,
including doctors and specialists.
After reviewing materials or attending in-person training, participants must pass an online test with a minimum score of 70%, given two attempts. Successful completion awards a certificate valid for three years.