Why should you enrol?

This course is designed for clinical research professionals who are committed to ensuring the high quality of their clinical trials with a solid foundation in all aspects of ICH GCP.

  • This course is developed by an industry GCP expert.

  • It is one of the only truly comprehensive online courses available. It covers all sponsor, investigator and IRB/IEC roles and responsibilities.

  • It is compliant with the E6(R2) updates.

  • It takes about 3 hours to complete and it is divided into modules that you can complete at your own pace.

  • The course includes a completion test. Once passed, the trainee receives a certificate showing completion of the course.

  • It is a beautifully designed course.

  • Profits from the course are used to support child education charity programmes.

Course curriculum

  • 1

    Welcome to the ICH GCP Foundation Course

  • 2

    Module 01: The Foundations and History of Good Clinical Practice

  • 3

    Module 02: The Framework: Quality and Electronic Systems

    • The Framework: Quality and Electronic Systems

    • In this module, you will learn and understand...

    • Module 02 - 27 Slides

    • Module 02: Knowledge Check
  • 4

    Module 03: Identifying/Training Resources and Allocating Responsibilities chapter

    • Identifying & Training Resources and Allocating Responsibilities

    • In this module, you will learn and understand...

    • Module 03 - 17 Slides

    • Module 03: Knowledge Check

  • 5

    Module 04: Designing a Study and Obtaining Ethics/Regulatory Approval

    • Designing a Study and Obtaining Ethics/Regulatory Approval

    • In this module, you will learn and understand...

    • Module 04 - 17 Slides

    • Module 04: Knowledge Check

  • 6

    Module 05: The Investigational Product

    • The Investigational Product

    • In this module, you will learn and understand...

    • Module 05 - 15 Slides

    • Module 05: Knowledge Check
  • 7

    Module 06: The Patient and the Consenting Process

    • The Patient and the Consenting Process

    • In this module, you will learn and understand...

    • Module 06 - 15 Slides

    • Module 06: Knowledge Check
  • 8

    Module 07: Recording Study Data, Monitoring Progress and Addressing Non-compliance

    • Recording Study Data, Monitoring Progress and Addressing Non-compliance

    • In this module, you will learn and understand...

    • Module 07 - 20 Slides

    • Module 07: Knowledge Check
  • 9

    Module 08: Managing Safety Information

    • Managing Safety Information

    • In this module, you will learn and understand...

    • Module 08 - 4 Slides

    • Module 08: Knowledge Check
  • 10

    Module 09: Closing the Study, Writing a Report and Archiving the Study Documentation

    • Closing the Study, Writing a Report and Archiving the Study Documentation

    • In this module, you will learn and understand...

    • Module 09 - 9 Slides

    • Module 09: Knowledge Check
  • 11

    Course Completion

    • Congratulations!

    • Before you go...

    • Test

Course Developed by

Hello, I am Mallorie Mitchell-Dellac!

I am the owner of Good Clinical People Ltd. I am a Clinical Quality Expert with 20 years’ experience in GCP Quality/Compliance and Clinical Operations. I have worked for sponsor companies, CROs and Academic Research Organisations. I am passionate about fostering consistent compliant behaviours and giving GCP guidance to the clinical study teams I support. I hope you enjoy the GCP course and tips you find on this site!

Course Price

Access to education is really important to me and I want this course to help as many students as possible. This is why I have decided to make this course free for all.

Social proof: reviews

ICH-GCP-E6 R2

Venkata Suneel Kumar P

Very Very Good learning to beginners as well as to clinical trial professionals

Very Very Good learning to beginners as well as to clinical trial professionals

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Knowledge

Jenisha Mary

Excellent

Excellent

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ICH-GCP Foundation Course - E6(R2)

Regiane Braga

Great course!

Great course!

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Excellent Course

Carola Effertz

Very comprehensive and well understandable

Very comprehensive and well understandable

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Great and Convenient

BISOLA NKANA

Provided me with a Refresher In ICH-GCP Foundation Course.

Provided me with a Refresher In ICH-GCP Foundation Course.

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Thorough and in-depth course

Mahmoed Seedat

The course is very thorough and in-depth. Providing a comprehensive overview of each party’s responsibilities in clinical trials. It also highlights the role...

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The course is very thorough and in-depth. Providing a comprehensive overview of each party’s responsibilities in clinical trials. It also highlights the role of constant oversight and alignment with established principles.

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5/5

samuel gwed

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ICh GCP E6(R2) Foundation Course - 2022

Karen Real

Clear and concise, a good course

Clear and concise, a good course

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