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Advance Refresher: Integrating ICH GCP E6 (R3) and NDoH Ethics in Health Research

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About Course

Course Introduction: Advanced GCP & Ethics Refresher (2025 Standards)

Welcome to your Advanced Refresher

Welcome to this 16-hour intensive training programme. This course is specifically designed for clinical research professionals, ethics committee members, and academic researchers who have previously mastered SA GCP Version 3 (2020) and now require an advanced bridge to the latest global and local regulatory landscapes.

Why This Training is Essential Now

The regulatory environment for clinical research in South Africa is currently undergoing its most significant transformation in years. To remain compliant with SA GCP 4.3.3.10, professionals must refresh their knowledge every three years. However, this year is different. We are moving beyond a “standard” update to address three major pillars of change:
 
  1. ICH GCP E6(R3) Transition: With the July 1, 2025 effective date fast approaching, we will move through the 13 revised principles. Our focus is on modernising trial conduct, specifically regarding data integrity and the proportional, risk-based approach to participant safety.
  2. The 2024 Declaration of Helsinki: The World Medical Association’s recent update expanded to 37 ethical principles. We will explore how these principles now explicitly encompass all health research professionals—ensuring that ethical obligations are shared by the entire study team, not just the physician.
  3. NDoH Ethics in Health Research (3rd Edition): Per Section 5.4 of the new National Department of Health guidelines, theoretical ethics training is no longer optional for those involved in human or animal research. This course fulfils the mandate for researchers, students, and REC administrators alike.

Learning Objectives

By the end of this 16-hour programme, you will be able to:
 
  • Navigate the complexities of the ICH GCP R3 framework and apply its core principles to modern trial designs.
  • Implement the 2024 Declaration of Helsinki updates within your current ethical oversight processes.
  • Demonstrate compliance with the NDoH 3rd Edition requirements for responsible and transparent research.

Certification & Requirements

To maintain the high standards required by the HPCSA and international monitors, this course is rigorous.
 
  • Accreditation: Upon successful completion, you will be awarded 16 CPD ethics points.
  • Assessment: To receive your certificate, you must achieve a minimum score of 80% in the final assessment.
Led by Dr Nyeleti Bicky Mthombeni (PhD), this training combines 18 years of clinical research expertise with a deep dive into the practical application of these new rules. Let’s begin by ensuring your research remains in line with global ethical and quality standards.
 
 
 
 
 
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What Will You Learn?

  • By the end of this advanced refresher, you will have transitioned from the 2020 standards to the cutting-edge 2025 regulatory landscape.
  • What You Will Learn:
  • The Ethical "Why": A deep dive into the history of research ethics—from the Nuremberg Code and Tuskegee to the Belmont Report—to ground your practice in the core principles of justice and beneficence.
  • The 2024 Helsinki Standards: Mastery of the 37 updated principles of the WMA Declaration of Helsinki, including the new mandate for all research professionals (not just doctors) to uphold ethical conduct.
  • ICH GCP E6(R3) Readiness: A comprehensive breakdown of the 13 new principles taking effect in July 2025, focusing on modernised trial designs, data integrity, and risk-based participant safety.
  • South African Legislative Compliance: Full alignment with the NDoH Ethics in Health Research (3rd Edition), satisfying the new mandatory training requirements for researchers, students, and REC members under Section 5.4.
  • Practical Application: How to implement these global updates within the South African context to ensure your research remains compliant, ethical, and audit-ready.

Course Content

Advanced Refresher for clinical trials staff
Course Introduction: Advanced GCP & Ethics Refresher (2025 Standards) Welcome to your Advanced Refresher Welcome to this 16-hour intensive training programme. This course is specifically designed for clinical research professionals, ethics committee members, and academic researchers who have previously mastered SA GCP Version 3 (2020) and now require an advanced bridge to the latest global and local regulatory landscapes. Why This Training is Essential Now The regulatory environment for clinical research in South Africa is currently undergoing its most significant transformation in years. To remain compliant with SA GCP 4.3.3.10, professionals must refresh their knowledge every three years. However, this year is different. We are moving beyond a "standard" update to address three major pillars of change: ICH GCP E6(R3) Transition: With the July 1, 2025 effective date fast approaching, we will move through the 13 revised principles. Our focus is on modernising trial conduct, specifically regarding data integrity and the proportional, risk-based approach to participant safety. The 2024 Declaration of Helsinki: The World Medical Association’s recent update expanded to 37 ethical principles. We will explore how these principles now explicitly encompass all health research professionals—ensuring that ethical obligations are shared by the entire study team, not just the physician. NDoH Ethics in Health Research (3rd Edition): Per Section 5.4 of the new National Department of Health guidelines, theoretical ethics training is no longer optional for those involved in human or animal research. This course fulfills the mandate for researchers, students, and REC administrators alike. Learning Objectives By the end of this 16-hour programme, you will be able to: Navigate the complexities of the ICH GCP R3 framework and apply its core principles to modern trial designs. Implement the 2024 Declaration of Helsinki updates within your current ethical oversight processes. Demonstrate compliance with the NDoH 3rd Edition requirements for responsible and transparent research. Certification & Requirements To maintain the high standards required by the HPCSA and international monitors, this course is rigorous. Accreditation: Upon successful completion, you will be awarded 16 CPD ethics points. Assessment: To receive your certificate, you must achieve a minimum score of 80% in the final assessment. Lead by Dr Nyeleti Bicky Mthombeni (PhD), this training combines 18 years of clinical research expertise with a deep dive into the practical application of these new rules. Let’s begin by ensuring your research remains at the forefront of global ethical and quality standards.

  • The Origins of Ethics in Health Research
    34:00
  • The 2024 WMA Declaration of Helsinki
    35:00

Module 1 : South African NDoH 2024 Revision 3

Module 2: ICH GCP R3

Exam
Passing Requirement: A minimum score of 80% is required to successfully pass the examination. Attempt Limit: Learners are permitted up to three attempts to achieve the passing score. Certification: Upon successful completion of the exam, a certificate will be issued to acknowledge your accomplishment.

Student Ratings & Reviews

5.0
Total 5 Ratings
5
5 Ratings
4
0 Rating
3
0 Rating
2
0 Rating
1
0 Rating
Seanokeng Mole
Seanokeng Mole
3 weeks ago
This was great
LH
Laaiqah Hussein
1 month ago
perfect
KM
Karabo Mabe
1 month ago
Not only was it educational but it was also interactive. It was definitely a good match
PM
Phatudi Maoto
1 month ago
Great Course and Great facilitator
FR
Faeeda Richards
2 months ago
Yes, most definitely. Very informative and I've learnt quite a few new ethical points.

info@afrileadtech.co.za

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