ICH-Good Clinical Practice E6 (R2) Training

This course is based on the international E6 ICH Good Clinical Practice regulations and is a complete training solution for all individuals that need to acquire GCP knowledge. 

Course Information

Our GCP training is designed for anyone carrying out or involved in clinical research and clinical trials. The knowledge is delivered in 10 modules with 28 videos, 8 assessments, and the Certification with international recognition from Transcelerate 

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Course Instructor

Constantin Nedescu Constantin Nedescu Author

Constantin Nedescu has vast life experience, having taken on many responsibilities and putting an accent on continuous education. He is a physician, a CEO, a mentor, a coach, a husband, a father, and a friend. He had started as a CRA 15 years ago and went through it all: senior CRA, lead site monitor, start-up specialist, and regional manager leading international teams for various projects in clinical research. Once you went through all the stages, what is the next step? Well, that is why we are here, building this community of professionals because the true fulfilment for Constantin is to pass on all this knowledge and experience over to you, to help you build a new and exciting carrier, support you in overcoming all the obstacles, reach your true potential.

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Module 1 – Introduction

Introduction in GCP Course

Module 2 – GCP Glossary

GCP Glossary Lesson 1
GCP Glossary Lesson 2
GCP Glossary Lesson 3
GCP Glossary Lesson 4
GCP Glossary Lesson 5

Module 3 – The Principles of GCP

Principle of GCP Lesson 1
Principle of GCP Lesson 2
Principle of GCP Lesson 3
Principle of GCP Lesson 4

Module 4- Institutional Review Board / Independent Ethics Committee (IRB/IEC)

IRB / IEC Lesson

Module 5 – Investigator

Investigator Responsibilities Lesson 1
Investigator Responsibilities Lesson 2
Investigator Responsibilities Lesson 3
Investigator Responsibilities Lesson 4
Investigator Responsibilities Lesson 5
Investigator Responsibilities Lesson 6

Module 6 – Sponsor

Sponsor Responsibilities Lesson 1
Sponsor Responsibilities Lesson 2
Sponsor Responsibilities Lesson 3
Sponsor Responsibilities Lesson 4
Sponsor Responsibilities Lesson 5
Sponsor Responsibilities Lesson 6

Module 7- Clinical Trial Protocol and Protocol Amendments

Study Protocol Lesson 1
Study Protocol Lesson 2

Module 8 – Investigator’s Brochure

Investigator’s Brochure Lesson

Module 9 – Essential Documents

Essential Documents Lesson 1
Essential Documents Lesson 2

Module 10 – Classification of Clinical Trials

Bonus Lesson