Consent Preferences

ICH E6 (R2) GCP Essentials
for investigators and site personnel

The goal of this short GCP training is to train clinical investigators and site personnel on the fundamentals of GCP and how to apply them practically in the research setting. It is also ideal as a GCP refresher, as it 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.

2,5hs

Average study time

€67

Price

English

LANGUAGE

The objective of this online GCP Good Clinical Practice training course is to train investigators and site personnel on investigator-specific responsibilities as outlined in Section 4 of the ICH E6 R2 guideline. This course is ideal for clinical trial staff with GCP experience, who are taking the course as a GCP refresher.  You will obtain an official certification in GCP that is widely accepted by all sponsors and CROs. 

You will learn how to apply good clinical practices in your daily work, at your own pace, with 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 investigator’s responsibilities related to:

  • Qualifications and Agreements
  • Resources
  • Medical Care of Trial Subjects
  • Communication with IRB/IEC
  • Compliance with Protocol
  • Investigational Products
  • Randomization Procedures and Unblinding
  • Informed Consent process and its key aspects;
  • Records and Reports
  • Progress Reporting / Final Reports
  • Safety Reporting
  • Premature Termination or Suspension of Trial

7. 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
  • 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

OVERVIEW

Ready to get your good clinical practice certification?

knock knock

"May I enter your inbox?"

Our newsletter is written for clinical research professionals who love to know more and care about consent.