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Good Clinical Practice for Clinical Research Professionals

Name: Good Clinical Practice for Clinical Research Professionals
Rating: 4.5 (1555 reviews)

[2026] Certified, Complete ICH GCP E6 R3 Course for Sponsors, Investigators, Monitors, Study Coordinators, Study staff

Bestseller

Role Play

Created byDr. Vincent Baeyens

Last updated 6/2026

English

What you'll learn

Identify and understand the ICH-GCP requirements throughout the conduct of clinical trials
Learn the core principles of ICH-GCP R3 and how to implement them in practice
Define the roles and responsibilities of each involved key stakeholder: Ethics Committees, Sponsors and Investigators
Understand the purpose of the essential documents and the best practice for filing in the TMF
Understand the essential requirements and contents of the Investigator's Brochure and the Protocol
Practice on real cases: Identify common ICH-GCP inspection findings (FDA warning letters) and how to avoid them
Practice on real cases: Conduct a gap analysis in your organization based on a real MHRA inspection report
Industry-Recognized Certification: Earn a certificate recognized across the industry, demonstrating your expertise in ICH-GCP to potential employers, sponsors,

Course content

14 sections • 58 lectures • 5h 14m total length

Welcome and Objectives3:24
Welcome to the course!
What is ICH-GCP E6 (R3) and what problems does it solve?11:18
What is ICH-GCP?
Awareness of the Most Common GCP Findings12:25
This section describes the most common major and critical GCP findings seen by Inspections and the sites, CROs and Sponsor level (+ short update 2023 in resource)

Key stakeholders in a Clinical Study6:44
Investigator, Sub-Investigator, Coordinating investigator, Sponsor, CRO, IRB, QA.
Key Processes in a Clinical Study9:35
Informed consent, Monitoring, Audit, Inspection, SAE reporting, Blinding/Masking.
Key Essential Documents11:00
Protocol, Clinical Study Report (CSR), Investigator's Brochure (IB), Case Report Form (CRF), Source Data, Contract.
Definitions

Submission and Communication2:55
Submission and communication rules with Ethics Committees.
Responsibilities13:24
The responsibilities of the Ethics Committees.
Composition, Functions and Operations2:24
The Composition, roles and operational rules of the Ethics Committees.
Procedures5:52
What procedures must Ethics Committees have in place.
Records1:13
Records keeping of Ethics Committees.
IRC / IEC Responsibilities

Qualifications and Training1:51
The importance of proper qualifications and trainings of investigators.
Resources2:37
Ensuring site's adequate resources to conduct clinical studies.
Responsibilities3:21
The key responsibilities of the investigators when running clinic studies.
Communication with IRB / IEC2:07
The role of the investigator in communicating properly with ethic committees.
Compliance with Protocol2:06
The obligation of compliance with the protocol by the investigator.
Premature Termination or Suspension of a Trial3:02
The rules that dictate the premature termination or suspension of a clinical trial at the site.
Participant Medical Care and Safety Reporting4:42
The adequate medical care of participants and duty, timely safety reporting of investigators.
Informed Consent of Trial Participants9:45
Adequate process to consent participants in clinical trials.
End of Participation in a Clinical Trial2:04
Ending the participation of participants in a clinical trial.
Investigational Product Management2:46
The responsibilities of the investigator to manage investigational products at the site.
Randomisation Procedures and Unblinding1:10
Key principles of randomization procedures, and unbinding.
Records and Reports7:46
Obligation of records keeping and reports at the site.
Investigator's responsibilities
Preparing for an FDA Inspection: Investigator-Site Responsibilities Overview

Trial Design - Resources - Allocation of Activities6:35
Trial design resources and allocation of activities as the first step as a sponsor.
Qualifications and Training0:40
Adequate qualifications and training of staff.
Financing - Agreements8:34
Importance of financing agreements in clinical trials.
Investigator Selection1:03
Key principles to select adequate investigators in a clinical study.
Communication with IRB/IEC and Regulatory Authorities2:05
Proper communication with ethics committees and regulatory authorities as a sponsor.
Sponsor Oversight5:13
The importance of ensuring proper level of sponsor oversight of vendors as a sponsor.
Quality Management6:12
Quality management organization and Quality-by-Design (QbD) in clinical studies.
Quality Assurance and Quality Control13:15
The role of quality assurance and quality control during clinical studies execution.
Non Compliance2:40
How to handle non-compliance in clinical trials.
Safety Assessment and Reporting3:24
Adequate safety assessment and reporting in clinical studies.
Insurance/Indemnification/Compensation to Participants and Investigators1:04
The importance of insurance indemnification and compensation, participants and investigators in clinical studies.
Investigational Product(s)4:45
Lifecycle management of investigational products in clinical trials.
Data and Records10:56
Ensuring robust data and records handling in clinical research.
Reports1:57
Timely reporting in clinical research.
Quiz
Initiating a Global Phase 3 Clinical Trial

General Administrative Information3:54
Admin information in clinical trial protocol.
Background Information, Trial Objectives and Purpose1:32
Writing background information and trial objectives and purpose in protocols.
Trial Design1:56
How to design a clinical trial adequately.
Selection and Withdrawal Criteria, Treatment of Subjects, Assessments2:51
Criteria to select and withdraw participants, adequate treatment of participants and assessment description.
Statisitics, and other Key Sections2:20
Key statistical considerations in clinical trial protocols.
Quiz

Introduction: Definition, and Purpose4:10
Key definitions, and purpose of essential documents in clinical studies.
Essential Documents Filing Before the Clinical Phase of the Trial commences1:27
Ensuring adequate essential document filing and approval before the clinical trial starts.
Essential Documents Filing During the Clinical Conduct of the Trial1:52
Handling essential documents filing during the execution of the clinical studies.
Essential Documents After Completion or Termination of the Trial1:46
Essential documents after full completion of the trial or early termination of it.
Filing location of Essential Documents

Requirements

No prior working experience or knowledge in clinical research is required to attend this course
This course is dedicated to beginners as wells as to more advanced professionals willing to refresh their knowledge

Description

Updates:

June 2026: Lecture to Introductory concepts of ANNEX 2 added

December 2025: Added 2 role play cases in the course. This is a great new feature offered by Udemy.

November 2025: Full update to Revision 3 of the ICH-GCP following its official release in July 2025.

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Welcome to the only up-to-date complete edition of the ICH GCP R3 (including ANNEX 1 and ANNEX 2) course!

This course meets the Minimum Criteria for ICH E6 GCP Investigator and Site Personnel Training that TransCelerate has identified as necessary to enable mutual recognition of GCP training.

This course offers the first professional, fundamental on-line ICH GCP detailed course for Investigators, Study Coordinators, Sponsors, Clinical Project Managers, Monitors and any other Clinical Study staff requiring knowledge in GCP for a successful execution your clinical trials.

My name is Dr. Vincent Baeyens PharmD, PhD, I have more than 20 years of experience in running Clinical Trials in Global and mid-size Pharma, and Biotech settings. I have worked with most of the Global as well as several niche CROs and I am also an expert in CRO Management and Oversight, budgeting and Risk Management.

In this course, you will be able to understand based on my experience the key ICH GCP requirements to design, conduct, record and report clinical trials in humans from A to Z. We will review the role and responsibilities of the key stakeholders and the structure of the essentials documents.

To facilitate the learning of beginner students, the course has been broken up on purpose in several small lectures.

Note: If you are a more advanced student, you can increase the speed of lecture to learn the course at your own pace.

This course will provide you with a strong support to prepare for successful regulatory ICH GCP inspections and audits.

I will lead you step-by-step through the ICH GCP E6, and you will learn & understand:

What is GCP and why GCP is important in clinical research
The link between the Declaration of Helsinki and current GCP
The definition of the key definitions of terms and concepts used in clinical research, including stakeholders involved and essential documents
The ICH GCP Principles and practical advices to apply them in your clinical trials
The responsibilities of ethics committees, its composition, function, operational aspects and obligations
The detailed responsibilities of the Investigator throughout the trial, including his/her qualifications, compliance to protocol, communication with Ethics Committees, safety reporting, and final reporting
Complying with Data Governance in Clinical Trials
How to write an adequate Protocol / protocol amendment and rationale for its structure
The What, the Why and the How for an effective writing of the Investigator's Brochure
The purpose of Essential Documents in clinical research: How and Where to file them in the Trial Master File (TMF)
ANNEX 2 with modern concepts of clinical trials
The common ICH GCP audit and inspection findings in clinical trials with practical exercises (FDA, MHRA)

Quizzes are proposed to test your knowledge along your journey. A final Quiz at the end of the course will consolidate your knowledge.

Feel free to look at the content of the course to know more and contact me any time if you have any questions,

I am looking forward to seeing you inside the course!

Sincerely,

Vincent

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Updates:

January 2024: Updated Bonus section; added the ICH-GCP (R3) Overview of comments received on Step 2. Comments will now be sent to the ICH E6 (R3) Expert Working Group for consideration in the context of Step 3 of the ICH process.

September 2023: Updated section of ICH GCP R3 Draft Principles and added resource documentation

August 2023: Added list of Acronyms and Abbreviations used in the course

June 2023: Added DRAFT ICH GCP (R3) Annexe 1 (interventional clinical trials), its summary of changes and explanatory video in the resources. This version is made available by the ICH for public consultation until September 2023 (step 2 of the ICH process)

May 2023: Added link to ICH E8 (R1) in resources of quality management

February 2023: Added awareness of the most common GCP findings

January 2023: Edited English subtitles

December 2022: Added assignment: Practical risk assessment based on UK MHRA inspection report

October 2022: Added assignment: Practical exercises from real FDA inspection cases

September 2022: Added updates on ongoing development of Revision 3 of ICH-GCP

Who this course is for:

This course is intended to all professionals involved in clinical research, such as clinical project manager, investigator, study nurse, study coordinator willing to comply with ICH-GCP

Good Clinical Practice for Clinical Research Professionals

What you'll learn

Explore related topics

Course content

Background and Introduction3 lectures • 27min

Definitions of key terms used in GCP3 lectures • 27min

Principles of ICH-GCP (R3)3 lectures • 52min

Institutional Review Board (IRB) / Independent Ethics Committee (IEC)5 lectures • 26min

Responsibilities of the Investigator13 lectures • 43min

Responsibilities of the Sponsor15 lectures • 1hr 8min

Data Governance4 lectures • 25min

Clinical Trial Protocol and Protocol Amendments5 lectures • 13min

Investigator's Brochure (IB)3 lectures • 13min

Essential Documents4 lectures • 9min

Requirements

Description

Who this course is for: