South African Good Clinical Practice Clinical Trial Guidelines

About Course

Good Clinical Practice (GCP) represents an international benchmark for designing, executing, overseeing, documenting, and reporting clinical trials. GCP guidelines are indispensable in guaranteeing the safety and trustworthiness of clinical trial data.

In accordance with South Africa’s GCP regulations, all personnel engaged in the clinical research field are required to undergo Good Clinical Practice training. Research conducted in South Africa must align with International Conference of Harmonisation GCP, SA GCP, and other relevant regulatory requirements.

Our GCP training covers the following areas:

ICH GCP R2: Stay informed about the latest revisions and criteria outlined by the International Council for Harmonisation.

South African Good Clinical Practice: Familiarize yourself with the Clinical Trial Guidelines version 3, 2020, ensuring your trials meet national standards.

Ethics in Health Research: Explore the Principles, Processes, and Structures in line with the Department of Health (DOH) 2015 guidelines, fostering a robust ethical foundation for your research journey.

Upon completing the program or attending the course, you will need to pass an online test with a minimum score of 70% (two attempts are allowed). Successful completion will grant you a certificate valid for three years. Participants will earn 16 Ethics points (equivalent to 16 hours of training) as it is officially accredited by the SAMA CPD Committee for HPCSA registered medical professionals, including doctors and specialists.

Wishing you the best as you enjoy this training from the comfort of your own home.

Your instructor is Ms. Nyeleti Bicky Mthombeni, the founder and partner at Afrileadtech School of Clinical Research. For more information about her, you can also follow her on LinkedIn:https://www.linkedin.com/in/nyeleti-bicky-mthombeni-78971733/

Understand pivotal historical events, such as the Nazi Medical War Crimes and the Tuskegee Syphilis Study, and their influence on modern clinical research guidelines.
Gain insights into the essential principles of GCP and the role of influential organisations like WMA, ICH GCP, and CIOMS in establishing these standards.
Compare South African GCP with international standards, appreciating the role of SAHPRA and NHREC in shaping local research practices and addressing potential guideline conflicts.
Analyse contemporary case studies, including the ivermectin experiment, to assess the application and challenges of GCP in today's research landscape.
Engage in real-world scenarios to apply, analyse, and evaluate clinical research practices, enhancing critical thinking and ethical decision-making abilities.

Course Content

Drug Discovery and Drug Development Introduction
The drug discovery and development process module begins the introduction GCP. Starting from the process of defining a medical need, identifying and validating potential drug targets, the process drug screening overview of how prospective drug candidates are screened and confirmed to be druggable. Followed by the introduction of pre-clinical studies evaluating these candidates' safety, dosing, and efficacy in controlled laboratory environments. The module introduces the clinical trial phases, each subject to strict regulatory mandates, extending from the initial Phase I studies to thorough post-marketing surveillance.

Drug discovery and development introduction

17:02
Preclinical studies

05:00
Clinical studies

08:00
Regulatory Market Authorisation

04:00
Post-marketing studies

07:00
Drug discovery and development quiz

Origins of Good Clinical Practice
This module delves deep into good clinical practices' principles, origins, and history. It provides participants with a comprehensive understanding of the ethical guidelines and standards that govern clinical research to ensure the safety and well-being of participants. The course materials reflect on past atrocities in medical research, laying a foundation for the current guidelines that guide clinical studies.

Introduction Origins history of Good Clinical Practice

03:00
Nazi war crimes

05:00
The Numberg code

14:00
Key Medical research Atrocities

12:00
The Belmont Report

32:00
Guidelines, principles and standards

01:24:00
SA Guidelines principles and standards

43:00
Post GCP case studies

13:00
Origins & history of GCP Quick Quiz

Sponsor Responsibilities

Sponsor, initiating and funding the trial.

09:53
Sponsor Responsibilities Introduction

01:42
Sponsor Responsibilities Design and Investigator

13:53
Sponsor Responsibilities Trial Management and Quality

15:58
Sponsor Responsibilities Management, Record keeping

07:20
Sponsor Responsibilities Reg Ethics ins fin

06:47
Sponsor Responsibilities for Mngt of IP

11:48
Sponsor Responsibilities Safety Management

03:56
Sponsor Responsibilities Monitor_Noncompliance Results

02:12
Sponsor Responsibility Quiz

Regulatory Authority

Regulatory Authority Introduction

19:08
Regulatory Authority SAPHRA Clinical Trials Regulations

09:34
Regulatory Authority initial Application

10:15
Regulatory Authority Post Approval Submission

10:22
Regulatory Authority Inspection

07:45
Regulatory Authority Insurance Requirements

06:44
Regulatory Authority Participants Reimbursements

05:30
Regulatory Authority Idemnity and conflict of interest

09:45
Regulatory Authority Post-Trial care

05:34
Regulatory Authorities Quiz

Ethics Commitee

Investigator Responsibilities

Investigators Responsibilities Introduction

14:00
Investigators Responsibilities Resources

11:00
Investigator responsibilities Recruitment

08:00
Investigators Responsibilities staff

28:00
Investigators Responsibilities medical care and protocol

11:00
Investigators Responsibilities informed consent

08:00
Investigators Responsibilities IP management

22:00
Investigators Responsibilities Safety Reporting

03:00
Investigators Responsibilities Records and Report

03:00
Investigator responsibility Quiz

Clinical Trial Documents

Source data Collection and Reporting

Informed Consent

Introduction to Informed Consent

10:00
Elements of informed consent

16:00
Development and Approval of Informed Consent

15:00
Informed consent special considerations

01:28:00
Conducting informed consent

01:00
Conducting Informed consent Scene 1

02:17
Conducting Informed consent Scene 2

02:23
Conducting Informed consent Scene 3

02:46
Conducting Informed consent Scene 4

02:40
Informed consent process Quiz

About Course

What Will You Learn?

Course Content

Drug discovery and development introduction

Preclinical studies

Clinical studies

Regulatory Market Authorisation

Post-marketing studies

Drug discovery and development quiz

Introduction Origins history of Good Clinical Practice

Nazi war crimes

The Numberg code

Key Medical research Atrocities

The Belmont Report

Guidelines, principles and standards

SA Guidelines principles and standards

Post GCP case studies

Origins & history of GCP Quick Quiz

Sponsor Responsibilities

Sponsor, initiating and funding the trial.

Sponsor Responsibilities Introduction

Sponsor Responsibilities Design and Investigator

Sponsor Responsibilities Trial Management and Quality

Sponsor Responsibilities Management, Record keeping

Sponsor Responsibilities Reg Ethics ins fin

Sponsor Responsibilities for Mngt of IP

Sponsor Responsibilities Safety Management

Sponsor Responsibilities Monitor_Noncompliance Results

Sponsor Responsibility Quiz

Regulatory Authority

Regulatory Authority Introduction

Regulatory Authority SAPHRA Clinical Trials Regulations

Regulatory Authority initial Application

Regulatory Authority Post Approval Submission

Regulatory Authority Inspection

Regulatory Authority Insurance Requirements

Regulatory Authority Participants Reimbursements

Regulatory Authority Idemnity and conflict of interest

Regulatory Authority Post-Trial care

Regulatory Authorities Quiz

Ethics Commitee

Introduction to Ethics in Clinical Research

Guiding principles for Ethical Research

Ethics Committee Infrastructure

Ethics review process

Ethical Oversight Quiz

Investigator Responsibilities

Investigators Responsibilities Introduction

Investigators Responsibilities Resources

Investigator responsibilities Recruitment

Investigators Responsibilities staff

Investigators Responsibilities medical care and protocol

Investigators Responsibilities informed consent

Investigators Responsibilities IP management

Investigators Responsibilities Safety Reporting

Investigators Responsibilities Records and Report

Investigator responsibility Quiz

Clinical Trial Documents

Essential Documents Introduction

Essential Documents Before, During and After

Essential Documents Protocol

Essential Documents Protocol Trial Design

Essential IB, Documents ICF and CRF

Clinical Trial Documents Quiz

Source data Collection and Reporting

Source data description, type and example

Source PI Responsibilities, templates and retention

Good Documentation Practice

Case Report Forms

Source Data Quiz

Informed Consent

Introduction to Informed Consent

Elements of informed consent

Development and Approval of Informed Consent

Informed consent special considerations

Conducting informed consent

Conducting Informed consent Scene 1

Conducting Informed consent Scene 2

Conducting Informed consent Scene 3

Conducting Informed consent Scene 4