Interpretation and Application of ICH E6(R2)

Welcome to Version 1.0 of Interpretation and Application of ICH E6(R2) – an online course developed by the MRCT Center with a multi-stakeholder international team of experts and reviewed and endorsed by the Training Subcommittee of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

This online training was developed in collaboration with and has been endorsed by ICH. At the end of the course, after successful completion of embedded quizzes, you will receive a certificate of completion. The recipient of GCP training is expected to retain this documentation of their training to fulfill the US National Institutes of Health (NIH) requirements for GCP training of clinical investigators and clinical trial staff (Notice NOT-OD-16-148). This online course also meets the TransCelerate GCP training minimum criteria.

This is an introductory course consisting of the following 10 modules that reflects the ICH Guideline  E6(R2): Guideline for Good Clinical Practice. The content is particularly directed at governmental regulatory reviewers and inspectors and is also applicable to other stakeholders including investigators, study teams, ethics committee members, research organizations and sponsors. This course takes approximately 5 hours to complete, while specific modules range from 20-40 minutes.

  • Module 1: What is ICH E6(R2) and how does it apply to regulatory reviewers and inspectors?
  • Module 2: The 13 Principles of ICH GCP
  • Module 3: IRB Responsibilities
  • Module 4: Investigator Qualifications and Responsibilities
  • Module 5: Sponsor Responsibilities
  • Module 6+7: Clinical Trial Protocol and Protocol Amendment(s) and Investigator Brochure
  • Module 8: Essential Documents
  • Module 9: GCP in Practice for Reviewers: Risk-based Monitoring as one element of Quality by Design
  • Module 10: GCP in Practice for Inspectors
  • Module 11: Key Takeaways of this Training

To access the modules, please follow these instructions: PDF icon ICH E6(R2) Enrollment Instructions.pdf

After completion of all modules with at least 80% accuracy, a certificate of completion can be obtained.

For any questions, please contact: Carmen Aldinger (caldinger@bwh.harvard.edu).

Learning Objectives

The primary learning objective of this activity is to learn key concepts of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) E6(R2) Guideline.

Additional Information

Provided by: 

Multi-Regional Clinical Trials Center of Brigham & Women's Hospital and Harvard

 

Hosted by Mass General Brigham

Course summary
Course opens: 
12/04/2019
Course expires: 
08/31/2026
Cost:
$0.00

These training modules were developed by the following individuals:

Sylvia Baedorf Kassis, MPHMRCT Center

Barbara Bierer, MDMRCT Center

Ivelisse Colon-Perez, BSAmgen

Barbara Hepworth-Jones, PhDGlaxoSmithKline

Jules Mitchel, MBA, PhDTarget Health

Mitchell Parrish, JDPanAmerican Clinical Research

Sarah White, MPH MRCT Center

Management of course planning:

Carmen Aldinger, PhDMRCT Center

Creative Design of slides:

Ivelisse Colon-Perez, BSAmgen

Audio recordings:

Sylvia Baedorf Kassis, MPHMRCT Center

Edward FitzGeraldAmgen

John SpencerAmgen

Instructional Design programmers:

Hedrick Ellis, Ed.M.Partners HealthCare

James Lacey, Ph.D.Partners HealthCare

This activity is not for credit.

 
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