Consent Preferences

ICH GCP E6 (R2) Good Clinical Practice
online training

This ICH E6 GCP Good Clinical Practice online Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

6hs

Average study time

€87

Price

English

LANGUAGE

The objective of this ICH GCP Good Clinical Practice training is to train clinical research professionals and anyone involved in clinical research, providing individuals with an official Good Clinical Practice Certification that is widely accepted by all sponsors and CROs.

This ICH GCP training course covers the 8 sections specified by the ICH GCP E6 R2 guideline and meets the training requirement for you to participate in international clinical trials. This comprehensive course is ideal for clinical trial staff without previous GCP training.

You will learn how to apply good clinical practices in your daily work, at your own pace, with an interactive content and real-life case studies. Successful completion (pass mark is 80%) of the exam will earn you an ICH GCP Certification.

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

KEY LEARNING OBJECTIVES

Upon completion of this course, you will be able to:

1. Summarize the purpose of the ICH GCP guidelines

2. List the Principles of ICH GCP

3. Comprehend the roles and responsibilities of the key players in a clinical trial:  the ethics committees, the investigators, sponsors, monitors and support staff;

4. Comply with documentation and reporting obligations, how to avoid GCP non-compliance and how to conduct a quality trial;

5. Understand the principles of data capture and importance of data quality;

6. Understand the informed consent process and its key aspects;

7. Understand the structure and content of the clinical trial protocol, its amendments and the investigator`s brochure;

8. Understand the purpose and types of the essential documents required for the conduct of a clinical trial;

9. Supplementary Chapter: US FDA GCP specifics

Who should attend this GCP training?

METHODOLOGY

Learning Path

  • What is ICH GCP?
  • GCP Definition
  • ICH-GCP E6 R2 Guideline Sections
  • Important Definitions
  • Summary
  • The Principles of ICH GCP
  • Summary
  • The responsibilities of the Regulatory Authorities
  • Institutional Review Board (IRB) / Independent Ethics Committee (IEC)
  • Preparing for IRB/IEC Annual Review
  • Composition, Functions, Operations, Procedures and Records
  • Summary
  • Investigator´s Qualifications & Agreements
  • Adequate Resources
  • Medical Care of Trial Subjects
  • Communication with IRB/IEC
  • Compliance with Protocol
  • Investigational Product
  • Randomization Procedures and Unblinding
  • Informed Consent of Trial Subjects
  • Records and Reports
  • Progress Reporting/ Final Reports
  • Safety Reporting
  • Premature Termination or Suspension of a Trial
  • Summary
  • Sponsor Responsibilities Overview
  • Quality management
  • Quality Assurance and Quality Control
  • Contract Research Organisations
  • Medical Expertise
  • Trial Design
  • Trial management, data handling, and record keeping
  • Investigator Selection
  • Allocation of responsibilities
  • Compensation to subjects and investigators
  • Financing
  • Notification/submission to regulatory authority(ies)
  • Confirmation of review by IRB/IEC
  • Information on investigational product(s)
  • Manufacturing, packaging, labelling, and coding investigational product(s)
  • Supplying and handling investigational product(s)
  • Record access
  • Safety information
  • Adverse drug reaction reporting
  • Monitoring
  • Audit
  • Non-Compliance
  • Summary
  • Clinical Trial Protocol and Protocol Amendments
  • Summary
  • Investigator Brochure
  • Summary
  • Essential documents
  • Summary

OVERVIEW

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