Good Clinical Practice- Foundation for clinical trials: Integrating SA GCP ICH GCP R3 and Ethics in Health Research

The Good Clinical Practice (GCP) foundations for clinical trials
The Good Clinical Practice (GCP) guidelines for clinical trials provide a comprehensive introduction for all individuals involved in clinical research. This training provides participants with essential knowledge of the key principles, internationally recognised guidelines, and step-by-step processes required to conduct high-quality clinical trials both ethically and effectively. The foundation course covers the latest standards, including the South African GCP version 3 (2020), the current International Council for Harmonisation (ICH) GCP E6 (R3), and the National Department of Health (NDoH) 2024 Ethics in Health Research. Completion of this course ensures that all staff members participating in clinical trials are compliant with the latest mandatory training requirements. Course Structure Module 1: Ethics in Health Research (NDoH 2024) – This module covers the fundamental ethical considerations and responsibilities in health research, guided by the latest requirements set out by the National Department of Health. Topics include participant rights, informed consent, research integrity, and the role of ethics committees. Module 2: Introduction to drug discovery and drug development Module 3: South African Good Clinical Practice (GCP), Edition 3 (2020) – This section delves into the South African GCP guidelines, focusing on regulatory frameworks, responsibilities of research staff, documentation, and quality assurance practices specific to the South African context. Module 4: International Council for Harmonisation (ICH) GCP E6 R3 – This module explores the global GCP standards, emphasising harmonised practices for clinical trials, investigator and sponsor obligations, data management, and safety reporting in accordance with ICH GCP E6 Revision 3. By completing this training, participants will acquire a thorough understanding of the regulatory, ethical, and operational frameworks that underpin successful clinical research. The course is suitable for all clinical trial staff, including investigators, coordinators, monitors, and support personnel, and helps ensure preparedness to uphold the highest standards in clinical trial conduct. After training, learners must pass an exam with a score of at least 80%. Successful candidates receive a certificate valid for three years. Training is accredited by HPCSA with 16 ethical CPD points.

GCP Foundation Course Introduction

08:00

Module 1: Introduction to Ethics in Health Research
In this session we embark on a journey through the origins and history of health research ethical oversight requirements. It's a story that begins in an era where new drugs were not mandated to undergo premarket safety assessments, leading to therapeutic disasters and shocking atrocities. Understanding this historical context is crucial, for it not only sheds light on the mistakes and missteps of the past but also paves the way for ethical, responsible, and patient-centered medical research practices today. We will embark on this enlightening journey together, exploring the challenges faced, lessons learned, and the evolution of health ethics The course materials reflect on past atrocities in medical research The learners will understand that, alongside the potential benefits of scientific research, there are potential risks to the people who participate in the journey that makes breakthroughs possible The module lays a foundation for the following modules on the principles and guidelines that are fundamental ethical principles in medical research

Module 2: South African NDoH 2024 Revision 3

Introduction to Ethics in Health Research: South African NDoH 2024

34:00
Ethical basis for decision-making in the review process

43:00
Considerations specific to research methodologies or contexts

63:00
Insurance against research-related bodily injury

07:00
NDoH Quiz 1
Informed consent: Vulnerability and Incapacity

01:17:00
Human and Animal Biological Material and Data for Research

38:00
Health Research Ethics Committees (HRECs)

53:00
Health Research Ethics Infrastructure

16:00
The National Health Research Ethics Council (NHREC) Quiz

Module 3: Introduction to Drug Discovery and Development

Module 4: SA GCP

Introduction Origins and History of Good Clinical Practice

25:00
Regulatory Authority Introduction

19:00
Regulatory SAHPRA Clinical Trials Regulations

29:00
Regulatory Authority Other Regulations

29:00
Investigator’s Responsibilities Introduction

51:00
Investigator Responsibilities Staff

29:00
Investigator Responsibilities IP Management

22:00
Introduction to Clinical Trial Documents

01:05:00
Practice Quiz for SA GCP

Module 5: ICH GCP R3

Introduction to R3 Guidelines

17:00
The 11 ICH R3 Principles

28:00
Institutional Review Boards

14:00
Investigators responsibilities (2.1-2.7)

33:00
Investigators responsibilities -Informed consent (2.8)

29:00
Investigators responsibilities_IP Management (2.10 )

12:00
Investigators responsibilities (2.9; 2.11- 2.13 )

21:00
Sponsor Responsibilities (3.1-3.9)

59:00
Sponsor Responsibilities – Quality Management (3.10-12)

47:00
Sponsor Responsibilities, safety, Insurance and IP (3.13-3.15 )

18:00
Sponsor Responsibilities, Data and Records (3.16-3.17)

18:00
Data Governance

28:00
Appendix A Investigator’s Brochure Clinical Trial

28:00
Appendix B Clinical Trial Protocol and Protocol Amendments

22:00
Appendix C Essential Records

39:00

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.

About Course

What Will You Learn?

Course Content

GCP Foundation Course Introduction

Origin and History

Founding Ethical Principles in Health Research- WMA Declaration of Helsinki

Founding Ethical Norms _ CIOMS Guidelines

Introduction to health ethics quiz

Module 2: South African NDoH 2024 Revision 3

Introduction to Ethics in Health Research: South African NDoH 2024

Ethical basis for decision-making in the review process

Considerations specific to research methodologies or contexts

Insurance against research-related bodily injury

NDoH Quiz 1

Informed consent: Vulnerability and Incapacity

Human and Animal Biological Material and Data for Research

Health Research Ethics Committees (HRECs)

Health Research Ethics Infrastructure

The National Health Research Ethics Council (NHREC) Quiz

Module 3: Introduction to Drug Discovery and Development

Drug discovery and development introduction

Pre-Clinical Studies

Clinical Studies

Regulatory Market Authorization

Post Marketing Surveillance

Drug Discovery and Drug development Quiz

Module 4: SA GCP

Introduction Origins and History of Good Clinical Practice

Regulatory Authority Introduction

Regulatory SAHPRA Clinical Trials Regulations

Regulatory Authority Other Regulations

Investigator’s Responsibilities Introduction

Investigator Responsibilities Staff

Investigator Responsibilities IP Management

Introduction to Clinical Trial Documents

Practice Quiz for SA GCP

Module 5: ICH GCP R3

Introduction to R3 Guidelines

The 11 ICH R3 Principles

Institutional Review Boards

Investigators responsibilities (2.1-2.7)

Investigators responsibilities -Informed consent (2.8)

Investigators responsibilities_IP Management (2.10 )

Investigators responsibilities (2.9; 2.11- 2.13 )

Sponsor Responsibilities (3.1-3.9)

Sponsor Responsibilities – Quality Management (3.10-12)

Sponsor Responsibilities, safety, Insurance and IP (3.13-3.15 )

Sponsor Responsibilities, Data and Records (3.16-3.17)

Data Governance

Appendix A Investigator’s Brochure Clinical Trial

Appendix B Clinical Trial Protocol and Protocol Amendments

Appendix C Essential Records

GCP foundation for clinical trial exam

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