Clinical Research Master Class – School of Clinical Research

About Course

A comprehensive and dynamic online training program designed to equip learners with the essential skills and knowledge required to excel in clinical research.
Our course is meticulously structured to guide you through the intricate process of conducting clinical trials, ensuring you gain a solid foundation and practical expertise.

Clinical Research Master Class:
The Clinical Research Master Class is a four-month online intensive program enriched with
practicals, workshops, and scenario-based modules. It offers a holistic view of the clinical trials process, from the project development plan to the final study report and an introduction to marketing authorisation. Our course structure follows an implementation of a protocol; every subject is aligned to the protocol and project deliverables. We teach the learners how to conduct clinical trials, how each role “work” to deliver clinical trial data, in an efficient, quality and as per regulatory requirements. We aim to immerse participants in a rich learning experience that seamlessly blends theoretical insights with hands-on workshop activities, preparing them for real-world applications in the clinical research domain.
Time Requirement for Clinical Research Masterclass
To fully benefit from the course and apply all the learning, the candidate must commit to 4- monthly schedule which will allow them to complete all work packages.

Who Qualifies
The training is designed for all roles, including investigators, study coordinators, CRAs, and regulatory and other service Providers in clinical research operations.
Good Clinical Practice (GCP)

Course Content

Design and planning of a clinical trial
As you embark on Module 1 of the Clinical Research Master Class, focusing on the design and planning of clinical trials, you'll gain a comprehensive understanding of the intricate processes involved in clinical research. In the first two weeks, you'll explore the strategic aspects of clinical development, delve into the basics of research methodology, and learn how to craft robust protocols and investigator brochures. Your journey will commence with learning the Clinical Development Strategy, where you'll uncover how pharmaceutical companies and research organizations chart the course from drug discovery to market. You'll then move on to the essentials of Research Methodology, acquiring hands-on knowledge of the research framework, from problem definition to ethical considerations and data collection techniques. As you progress, you'll gain insights into the development of protocols and investigator's brochures, learning how to summarize study details effectively and define clear study objectives. You'll also scrutinize various study designs and learn to identify appropriate assessments and procedures for clinical trials. Throughout this module, you'll be guided by the case study of Candy001, a treatment for diabetes undergoing a Phase III trial, which will serve as a practical example to apply your newfound knowledge. By the end of this module, you will be well-equipped with the foundational skills to excel in the field of clinical research and make a meaningful impact on global health initiatives. Prepare to immerse yourself in the world of clinical trials, where your expertise will begin to blossom.

Basics of Research Methodology Part 1 of 2

48:00
Basics of Research Methodology Part 2 of 2

46:00
Clinical Development Strategy

43:05
Protocol and Investigational Product Brochure

48:13

Project Management Fundamentals
Project management is a critical discipline that provides a structured framework to guide a project from inception to completion, ensuring goals are met while adhering to predetermined constraints such as cost, schedule, quality, and resource availability. In the context of clinical projects, this discipline takes on additional significance due to the complexity of balancing technological demands with the human resources required to not only finish the project but also ensure patient safety during clinical trials. Clinical trials are intensive projects that necessitate meticulous planning and execution. They involve a range of specialized individuals working together to achieve a common goal within a specified timeframe. The duration of these research endeavors can vary greatly, from several months to over a decade, yet the principles of project management remain consistent and are pivotal for success. Effective clinical research project management is essential for ensuring that the research is conducted within the allotted time, budget, and technological constraints, all while complying with strict regulatory requirements. The project manager's role encompasses planning, budgeting, prioritizing, and controlling the project to release a clinical trial product that meets all necessary standards and regulations. The masterclass in project management fundamentals is designed to equip participants with the necessary skills to manage such intricate projects successfully. The course covers key areas of project management including: Project Integration: Ensuring that project processes work together seamlessly. Scope Management: Defining and controlling what is and is not included in the project. Time Management: Planning the timeline and ensuring the project stays on schedule. Cost Management: Estimating costs and controlling the budget. Quality Management: Ensuring that the project meets the defined quality standards. Human Resource Management: Organizing, managing, and leading the project team. Communication and Stakeholder Management: Managing communications and engaging with stakeholders effectively. Risk Management: Identifying, analyzing, and responding to project risks. Procurement: Acquiring goods and services from external sources. By mastering these fundamentals, project managers in the clinical research field can facilitate the smooth execution of trials,

Project Integration

55:14
Project Scope Management

38:06
Project Time Management

41:32
Project Quality Management

42:09
Project Human Resource Management

34:45
Project Cost Management

45:58
Communication and Stakeholder Management

46:28
Project Risk Management

43:46
Project Procurement Management

56:53
Project Management Fundamental Quiz

Clinical Project Management

Introduction to Clinical Project Management

24:21
Clinical study planning

26:09
CPM Project Start-up activities

35:01
Study Documents and study Plans development

33:58
Developing study documents Demo-Template Monitoring plan

06:34
Clinical study vendors and vendor management

51:09
Clinical study systems

55:07
Clinical study budgets and contracts

54:19
Study Team and training of study team

01:21
Project Risk Management

33:42
Introduction to Site Management

12:51
Clinical Project Manager Responsibility Quiz

Quality Management

Site Set-up, Feasibility and Selection

Clinical Trial Regulatory Submission_SAHPRA

Ethics Application Process -South Africa

Conducting Site Initiation and Activation

Clinical Study Conduct

Clinical Study Monitoring

Introduction to site monitoring

33:48
On-site Monitoring Overview

46:30
Remote Monitoring Overview

10:43
Monitoring Site 710 participants 710001 Source Review

46:17
Monitoring AESI, Recap on Data Capture, Performing SDV in EDC

34:26
Post-monitoring Activities

25:33
Managing non-compliances

47:44
Study Execution

24:36
Study Monitoring Quiz

About Course

Course Content

Basics of Research Methodology Part 1 of 2

Basics of Research Methodology Part 2 of 2

Clinical Development Strategy

Protocol and Investigational Product Brochure

Project Integration

Project Scope Management

Project Time Management

Project Quality Management

Project Human Resource Management

Project Cost Management

Communication and Stakeholder Management

Project Risk Management

Project Procurement Management

Project Management Fundamental Quiz

Clinical Project Management

Introduction to Clinical Project Management

Clinical study planning

CPM Project Start-up activities

Study Documents and study Plans development

Developing study documents Demo-Template Monitoring plan

Clinical study vendors and vendor management

Clinical study systems

Clinical study budgets and contracts

Study Team and training of study team

Project Risk Management

Introduction to Site Management

Clinical Project Manager Responsibility Quiz

Quality Management

Introduction to quality management systems

Basics of Quality Risk Assessment

Quality Issue Management

Root Cause Analysis and Impact Analysis

CAPA

Basics of Audit Preparation Hosting Closure

Site Set-up, Feasibility and Selection

Requirements for setting up a site

Funding and Operations of Research site

Country level feasibility

Site Level Feasibility

Performing Site Selection visit

Clinical Trial Regulatory Submission_SAHPRA

Regulatory Authority SAHPRA Introduction

Regulatory Submission Process SAHPRA Initial Clinical Trial Application

Regulatory Submission Process SAHPRA Site Staff Documents

SAHPRA Post Submission Communication to Approval

SAHPRA Post-Approval Submissions CTF2 and CTF 3

SAHPRA Other Submissions and Common Applications

SAHPRA CTF1 Submission Assignment Explained

Ethics Application Process -South Africa

Agenda for the session

Introduction to Ethics Applications

SA Ethics Application Process

Customization of Informed Consent

Oversight of Biological Samples

Safety Reporting Process

Other Applicable Approvals

Import & Export of Biological Substances

Conducting Site Initiation and Activation

Introduction and Preparation for SIV

Conducting SIV

Report writing and site activation

Demonstration SIV Preparation Documents and Templates

Demonstration ISF Index Documents and Templates

Demonstration SIV all other Documents and Templates

Group Assignment Explanation 08 May 2024

Clinical Study Conduct

Introduction to conducting study procedures

Recruitment of study participants

Obtaining Informed consent and enrolment

Conducting study _Study Procedures

Conducting study Procedure_Safety

Conducting study Procedures _Investigational Product

Conducting Study Procedure _Data Capturing

Clinical Study Monitoring

Introduction to site monitoring

On-site Monitoring Overview

Remote Monitoring Overview

Monitoring Site 710 participants 710001 Source Review