Name: Certification Course in Clinical Research, ICH-GCP, E6 (R3),
Rating: 4.2 (36 reviews)

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Created byPrimepharmacovigilance academy

Last updated 6/2026

English

What you'll learn

• identify and understand the ICH-GCP requirements throughout the conduct of clinical trials
• Declaration of Helsinki guideline and principle
• 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 key process in clinical study
• Understand drug development and discovery, clinical trial history
• Understand the essential requirements and contents of the Investigator's Brochure and the Protocol
• Fundamentals of ICH-GCP
• Principles of ICH-GCP
• Roles & Responsibilities of IRB/IEC
• Roles & Responsibilities of Investigator
• Roles & Responsibilities of Sponsor
• Investigator's Brochure (IB)
• Clinical Trial Protocol and its Amendment
• Essential Records for the conduct of Clinical Trial
• Master the drug discovery and development lifecycle, from preclinical studies to post-marketing surveillance (Phase IV)
• Clearly differentiate Phase I, II, III, and IV clinical trials, including their objectives, design, and practical applications
• Learn the fundamentals of randomized controlled trial (RCT) designs, including randomization, blinding, placebo, and control groups
• Learn the key components of protocol design and the core methodology of clinical trial planning
• Apply ICH-GCP principles and global Good Clinical Practice guidelines in real clinical research scenarios
• Understand the role of regulatory authorities, ethics approvals, and the drug approval pathway including NDA submission
• Learn how to manage essential documents, source records, and Trial Master File (TMF) documentation
• Learn how to apply ethical principles, including informed consent, subject rights, confidentiality, and participant protection
• Understand the roles and responsibilities of investigators, sponsors, CROs, ethics committees, and research teams

Course content

15 sections • 47 lectures • 9h 14m total length

ICH GCP (R3) + Clinical Research6:59
Investigation New Drug Application, Gateway to Clinical Trials10:06
Explore how investigational new drug (IND) applications establish the regulatory blueprint with the FDA for first-in-human trials, detailing preclinical safety, manufacturing, protocols, and investigator qualifications.
Drug Discovery and development30:15
Navigate the drug discovery and development cycle from target identification to FDA approval. Explore lead optimization, preclinical safety, IND and NDA steps, and ICH-GCP guidelines.
Life Cycle of Medicine4:53
Navigate the life cycle of medicine from discovery and preclinical development to four clinical phases and regulatory approval.
Introduction to the Phases of Clinical Trials13:30
Quick Recap: Phases of Clinical Trials – Phase 0 and Phase I4:34
Examine the phases of clinical trials from phase 0 microdosing to phase I safety testing under the ICH GCP framework. Understand dose, administration routes, and pharmacokinetics basics.
Quick Recap: Phases of Clinical Trials Phase II to Phase IV9:39
Clinical Research and types Studies4:54
Clinical Trial Study Designs types9:11
Randomized Controlled Trial (RCT) and types8:07
Key Clinical Trial Designs: Parallel Design3:50
Understanding Cross-over, Cluster, and Factorial Designs in Clinical Trials11:42
Understanding of N-of-one trials, mega trials and Sequential trials8:00
Interventional and Non-interventional clinical trial types10:25
Understanding Randomized Controlled Trials (RCTs) and Blinding20:17
Understand blinded randomized controlled trials, including single, double, and triple blinding, two-group designs with placebo, and how randomization reduces bias to ensure reliable data in clinical research.
Decentralized Clinical Trials Types and Workflow15:10
Explore decentralized clinical trials (DCT) using telemedicine, wearables, and electronic consent, with fully decentralized, hybrid, and fully centralized designs that bring visits closer to patients.
Stages of the Clinical Research Process11:43
Quiz on states of the clinical trial
Quiz 1

What is ICH-GCP International Standards for Clinical Research8:39
What is Good Clinical Practice (GCP)5:11
GCP Guidelines core Goals in Clinical Trials4:33
ICH GCP 11 Fundamental Principle17:40
Explore the 11 fundamental principles of ICH GCP E6 (R3), from ethics and informed consent to quality by design and good manufacturing practice, guiding ethical and scientifically sound clinical trials.
Planning of the Study and Ethics Approval7:11
Learn how planning the study and ethical approval safeguard participant safety and rights by preparing the protocol, informed consent forms, risk–benefit assessments, and submitting to the IRB for approval.
ICH GCP Content and overview &objective8:21
Explore the ICH GCP guidelines, an ethical and scientific standard for clinical trials that protect participant rights, safety, and well-being while ensuring credible, reliable data.
The evolution of Good Clinical Practice4:19
Explore the evolution of good clinical practice from E6R1 to E6R3, highlighting ethical conduct, data reliability, and patient-centered, digitally enabled trials.
Historical background6:47
Explore the historical roots of clinical research, from the Nuremberg Code to Helsinki, Kefauver amendments, and Belmont Report, emphasizing informed consent, risk-benefit balance, and ethical review.
DECLARATION OF HELSINKI13:08
Explore the Declaration of Helsinki, its historical context from the Nuremberg trials to modern ethical standards, and how its principles protect participants' rights, safety, and well-being in clinical research.
General Principles of the Declaration of Helsinki5:29
Safeguard health, rights, and well-being of human subjects in medical research under the general principles of the Declaration of Helsinki.
TUSKEGEE SYPHILIS STUDY- 1932 TO 19725:08
Trace the tuskegee syphilis study (1932-1972) by the U.S. Public Health Service, involving 600 African American men, and its role in shaping the Belmont Report and informed consent.
Key differences beetween ICH-GCP R2 and ICH-GCP R316:53
Explore how ICH GCP r3 replaces 13 r2 principles with 11 broader principles, emphasizing proportionality, participant-centric trials, and technology-driven data governance for modern clinical research.
Elements of GCPs8:14
ICH guidelines 4 main topics (Quality, Safety, Efficacy and Multidisciplinary8:27
Key stakeholders in the research process and responsibilities of IRB/IEC9:19
Learn how IRB/IEC safeguard participant rights and safety, review protocols and informed consent, and monitor trials. See how sponsors, investigators, and data governance ensure regulatory compliance and data integrity.
Investigator brochure and inform consent process5:32
Quiz

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
• Laptop / PC/ Cellphone
• Good Internet connection
• Basic English

Description

Build a Strong Foundation in Ethical & Compliant Clinical Research

Do you want to understand how clinical trials are conducted ethically, safely, and in compliance with global regulations?

This Good Clinical Practice (ICH-GCP) – Full advanced certificate Course provides a comprehensive and practical understanding of the ICH-GCP guidelines, the international standard for designing, conducting, monitoring, and reporting clinical trials involving human participants.

Whether you are new to clinical research or looking to strengthen your GCP knowledge, this course will help you confidently understand regulatory expectations, participant safety, and data integrity across all phases of clinical trials.

What You Will Learn

Core Principles of ICH-GCP
Understand the fundamental ethical and scientific principles that protect trial participants and ensure reliable, high-quality clinical data accepted worldwide.

Roles & Responsibilities of IRB / IEC
Learn about the composition, functions, review processes, documentation, submissions, and communication requirements of IRB/IEC.

Roles & Responsibilities of the Investigator
Gain clarity on investigator duties including protocol compliance, informed consent, participant safety, safety reporting, investigational product management, randomization, unblinding, and trial close-out.

Roles & Responsibilities of the Sponsor
Understand sponsor oversight, quality management, safety assessment and reporting, investigational product handling, data and record management, non-compliance management, and clinical study reporting.

Investigator’s Brochure (IB)
Learn the purpose, development, structure, and contents of the Investigator’s Brochure, including reference safety information and risk–benefit assessment.

Clinical Trial Protocol & Amendments
Understand the structure and contents of a clinical trial protocol, protocol compliance, and when and how protocol amendments are implemented and approved.

Essential Documents in Clinical Trials
Learn about essential records required before, during, and after a clinical trial and their importance for audits and regulatory inspections.

Clinical research

Gain a strong understanding of the definition, scope, and real-world importance of clinical research in modern healthcare

Explore the history and evolution of clinical trials, including major milestones in research ethics and participant safety

Learn how to apply ethical principles, including informed consent, subject rights, confidentiality, and participant protection

Understand the roles and responsibilities of investigators, sponsors, CROs, ethics committees, and research teams

Master the drug discovery and development lifecycle, from preclinical studies to post-marketing surveillance (Phase IV)

Clearly differentiate Phase I, II, III, and IV clinical trials, including their objectives, design, and practical applications

Learn the fundamentals of randomized controlled trial (RCT) designs, including randomization, blinding, placebo, and control groups

Learn the key components of protocol design and the core methodology of clinical trial planning

Apply ICH-GCP principles and global Good Clinical Practice guidelines in real clinical research scenarios

Understand the role of regulatory authorities, ethics approvals, and the drug approval pathway including NDA submission

Learn how to manage essential documents, source records, and Trial Master File (TMF) documentation

Why Take This Course?

Industry-Recognized Certificate
Earn a certificate demonstrating your knowledge of ICH-GCP and clinical research compliance.

Career Growth & Job Readiness
Enhance your skills for roles in clinical operations, monitoring, regulatory affairs, pharmacovigilance, and research coordination.

Globally Applicable Knowledge
ICH-GCP is recognized worldwide—this course prepares you for international clinical research opportunities.

Beginner-Friendly & Practical
No prior experience required. Concepts are explained clearly with real-world relevance.

Who This Course Is For

Clinical Research Associates (CRAs)
Clinical Trial Coordinators
Investigators & Sub-Investigators
Regulatory Affairs Professionals
Pharmacovigilance & Clinical Operations Professionals
Students and anyone interested in ethical clinical research

Who this course is for:

• Clinical Research Associates (CRAs)
• Clinical Trial Coordinators
• Investigators & Sub-Investigators
• Regulatory Affairs Professionals
• Pharmacovigilance & Clinical Operations Professionals
• Pharmacist, physician and Nurse
• Students and anyone interested in ethical clinical research
• Site staff, study coordinator, Data management manager, clinical research associate
• B pharmacy, M pharmacy freshers

What you'll learn

Explore related topics

Course content

Introduction to Clinical Research17 lectures • 3hr 3min

Key Process in clinical study explained1 lecture • 25min

Key Stakeholder in a Clinical Study1 lecture • 27min

ICH GCP Content and 11 Fundamental principle16 lectures • 2hr 15min

Roles and responsibilities of the sponsor1 lecture • 30min

Roles and Responsibilities of an Investigator1 lecture • 25min

Roles and responsibilities of Institutional Review Board and IEC1 lecture • 11min

Data Governance role and responsibilities (Investigator and Sponsor)1 lecture • 23min

Roles and Responsibilities of Research Participants/subject1 lecture • 9min

REGULATORY AUTHORITY - Role & Responsibilities in Clinical Trials1 lecture • 7min

Requirements

Description

Who this course is for: