Course Information
Registration period
Year-round Recruitment
Course Level
Study Mode
Duration
3 Hour(s) 17 Minute(s)
Language
English
Taught by
Saurabh Kundgar
Rating
Course Overview
Good Clinical Practice, E6 R(3) Amendment, Clinical Research, ICH-GCP, Clinical Trial Guidelines, Ethical trials, Safety
Master the Global Standard That Governs Clinical Trials Worldwide!
Good Clinical Practice (GCP) is the foundation of ethical, high-quality, and compliant clinical research.
If you are a Pharmacy, Life Sciences, Biotechnology, or Medical graduate looking to build a career in Clinical Research, CROs, Pharma Companies, or Hospitals, this course is designed exactly for you.
This comprehensive GCP Masterclass takes you from basic concepts to real-world application, explained in simple, easy-to-understand language, with practical examples and industry-relevant insights.
Why Choose This Course?
Many students memorize GCP guidelines but struggle to apply them in real clinical trials.
This course bridges that gap by explaining not just WHAT GCP says, but HOW it is implemented at sites, by sponsors, and during monitoring.
Whether you are:
A student preparing for interviews
A working professional upskilling for career growth
Someone transitioning into clinical research or pharmacovigilance
This course will give you clarity, confidence, and job-ready knowledge.
What You Will Learn
By the end of this course, you will be able to:
Understand the principles and importance of Good Clinical Practice
Explain ICH-GCP E6 (R2/R3) guidelines with confidence
Understand ethics in clinical research and patient protection
Understand roles & responsibilities of Investigator, Sponsor, Regulatory Authority, CRO, and Study participants
Gain clarity on concepts like Risk-based approach, Quality by Design, Informed Consent, Quality management systems
Understand monitoring, auditing, and regulatory inspections
Understand essential Guidelines, Updates and Latest amendments
Prepare confidently for Clinical Research interviews
How This Course Is Structured
Step-by-step learning from beginner to advanced
Simplified explanations of complex guidelines
Real-world examples and case-based learning
Industry-focused approach aligned with CRO & Pharma expectations
Designed for students with no prior clinical research experience
Good Clinical Practice is not optional - it’s essentially the License to Work in Clinical Research.
Enroll now and build a strong foundation for a successful career in Clinical Research, Pharma, and Life Sciences.
Click ENROLL NOW and take your first step toward a compliant and confident CLINICAL RESEARCH CAREER!
Course Content
- 27 section(s)
- 26 lecture(s)
- Section 1 Introduction
- Section 2 What is GCP?
- Section 3 Principle 1 - Ethics in Clinical Trials
- Section 4 Principle 2 - Risk Vs Benefit
- Section 5 Principle 3 - Trial Participants & Safety
- Section 6 Principle 4 - Information on an Investigational Product
- Section 7 Principle 5 - Good Quality Trials
- Section 8 Principle 6 - Compliance with Study Protocol
- Section 9 Principle 7 - Medical Decisions & Responsibility
- Section 10 Principle 8 - Trial Staff competency
- Section 11 Principle 9 - Informed Consent in Clinical Trials
- Section 12 Principle 10 - Clinical Trial Data
- Section 13 Principle 11 - Confidentiality in Clinical Trials
- Section 14 Principle 12 - Good Manufacturing Practices
- Section 15 Principle 13 - Quality Assurance Measures
- Section 16 Major Stakeholders in Clinical Trials
- Section 17 THE SPONSOR - Role & Responsibilities in Clinical Trials
- Section 18 REGULATORY AUTHORITY - Role & Responsibilities in Clinical Trials
- Section 19 ETHICS COMMITTEE - Role & Responsibilities in Clinical Trials
- Section 20 PRINCIPAL INVESTIGATOR - Role & Responsibilities in Clinical Trials
- Section 21 STUDY PARTICIPANTS - Role & Responsibilities in Clinical Trials
- Section 22 QSEM Guidelines Framework of ICH-GCP
- Section 23 E6 Guidelines and E6 R(3) Amendment
- Section 24 E6 R(3) Amendment Updates - Part 1
- Section 25 E6 R(3) Amendment Updates - Part 2
- Section 26 Course Summary
- Section 27 Course Quiz
What You’ll Learn
- Introduction to Good Clinical Practices (GCP), History of ICH-GCP Guidelines, 13 Principle of Good Clinical Practices, Major Stakeholders in Clinical Trials, ICH E6 Efficacy guidelines for Clinical Trials, ICH-GCP E6 R(3) Amendment, Understanding important updates in E6 R(3) Amendment, Risk-Based Approach to Clinical Trials, Data Quality and Integrity in Clinical Trials, Informed Consent in Clinical Trials, Quality Management System (QMS), Quality by Design (QbD) in Clinical Trials, Patient Centric Clinical Trials, Understanding Sponsor role & responsibilities, Understanding Ethics Committee role & responsibilities, Understanding Principle Investigator role & responsibilities, Understanding Study participants role & responsibilities, Understanding Regulatory Authority role & responsibilities, Monitoring Clinical Trial process, Risk Based Monitoring, Ethics in Medical Research, Ethical conduct of Clinical Trials, Informed Consent in Clinical Trials, Protocol compliance in Clinical Trials, Ethics Committee/ IRB in Clinical Trials, Clinical Trial Data Management
Skills covered in this course
Reviews
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AAlec Anaximandro Herra Cortez
Very well explained and synthesized to understand the importance of GCP involved in clinical trials
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AArpana Mate
It was a very informative course.
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UUdemy User
Clear explanation and easy to understand
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DDr. Minakshi kadam
well explained and clearly mentioned about each thing
