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ICH GCP E6 R3 Good Clinical Practice Training for investigators & staff

A concise, practical review to easily update your knowledge including Annexes 1 & 2. TransCelerate-approved and built for active clinical investigators.

⭐⭐⭐⭐⭐  4.8 — 94 verified reviews      6,000+ certified professionals

Expert author: Adam Williams

3hs

Average study time

€87

Price

English

LANGUAGE

Yes

Final Exam

Professionals from these organisations have completed our training

Certification

Upon completion, you will receive an official, accredited ICH GCP E6 R3 certification, fully qualifying you to work on international clinical trials globally. You can download it and post it on LinkedIn.

Description

The goal of this ICH GCP training is to train investigators and site personnel on all of the specific topics that TransCelerate BioPharma, Inc. has identified as necessary to enable mutual recognition of GCP training.
This online ICH GCP course is ideal for clinical trial staff with ICH GCP experience who are taking the course as a GCP refresher. You will receive an official Good Clinical Practice certification that is widely recognized 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 a Good Clinical Practice Certification.
This training course includes Annexes 1 and 2.

What you will learn?

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

  • Summarize the purpose of the ICH GCP guidelines
  • List ICH GCP principles
  • Recognize the investigator’s obligations 
  • Recognize Data Governance requirements for Investigator and Sponsor
  • List the essential records required for the conduct of a clinical trial
  • ICH GCP E6 R3 Glossary

Who should enrol?

  • Physicians and staff working in health institutions (e.g., nurses, etc.) expecting to start a career in clinical research and requiring a documented Good Clinical Practice Certification.
  • Experienced physicians, investigators, and clinical research staff (e.g. nurses, study coordinators, etc.) requiring a documented Good Clinical Practice Certification.
  • Investigators from University Hospitals, research institutes, and research nurses
  • Ethics committee members

Curriculum

  • What is ICH GCP?
  • GCP Guideline Scope
  • ICH-GCP E6 R3 Guideline Structure
  • The need for the ICH GCP E6 R3 guideline
  • Principles of ICH GCP
  • General considerations
  • Qualifications & Training
  • Responsibilities and Resources
  • Communication with IRB/IEC
  • Compliance with Protocol
  • Premature Termination or Suspension of a Trial
  • Participant Medical Care and Safety Reporting
  • Informed Consent of Trial Participants
  • End of Participation in a Clinical Trial
  • Investigational Product Management
  • Randomization Procedures and Unblinding
  • Records
  • Documentation and Reporting
  • The investigator’s role in risk management
  • Data processing and storage (GDPR)
  • Data Governance and Data Integrity
  • Safeguard Blinding in Data Governance
  • Data Life Cycle Elements
  • Computerised Systems
  • Appendices: General considerations
  • Communication with IRB/IEC
  • Informed Consent Considerations
  • Investigational Product Management
  • Investigator Oversight
  • Safety Assessment and Reporting
  • New Glossary
  • Advisory and regulatory bodies
  • Important laws
  • USA legislation
  • EU legislation
  • Japan legislation
  • UK legislation

Reviews

⭐⭐⭐⭐⭐ What 6,000+ certified professionals say

FAQ: Good Clinical Practice certification and Good Clinical Practice training program

Yes, our Good Clinical Practice certification is fully updated to include ICH E6 (R3), ensuring you stay compliant with the latest regulatory changes.

This Good clinical practice training is designed for life science professionals, including CRAs, Investigators, and Sponsors, who need a recognized certification that meets TransCelerate criteria.

Absolutely. Our certification follows the harmonized ICH guidelines, making it globally accepted for clinical research professionals in the US, EU, and beyond.

  • ICH GCP E6 R3 Good Clinical Practice training:  is suitable to train clinical research professionals (those working in the Pharmaceutical Industry and CROs, as for example, CRAs/Monitors) that need a more comprehensive knowledge of ICH GCP. This GCP training is also ideal for people just starting or willing to start working in the Pharmaceutical industry, CROs or Clinical Sites, as it provides comprehensive and practical  knowledge of the ICH GCP Guideline.  
  • ICH GCP E6 R3 Good Clinical Practice training for investigators and site personnel : is suitable to train clinical investigators and site personnel (in English and Spanish, respectively) 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.

This will depend on the course; nevertheless, learners may complete the modules at their own pace.

GCP training for investigators will approximately take around 2.5 hours to complete, as it is mainly focused on investigators’ responsibilities.

The full GCP course will take around 8 hours to complete. 

How long is GCP training valid? This is a recurring question. Nevertheless, there is no uniform standard regarding how frequently GCP training should occur. However, regulatory authorities and auditors/inspectors usually require Good Clinical Practice training to be refreshed every 3 years. Please check your country’s regulations.

A quiz is also required in order to obtain the Good Clinical Practice Certification. Usually, the passing score is greater than or equal to 80%.

Yes, our 3 GCP courses are mutually recognized by TransCelerate BioPharma. You could review each course in detail on the COURSE page.

Yes. When you complete an ICH GCP training with PharmaEduCenter, you will receive your official GCP R3 certificate electronically, which you can print and share with sponsors and CROs immediately.

Yes, at the end of each GCP course there is a quiz you will need to pass in order to demonstrate you have acquired the knowledge and are appropriately trained. The passing score is greater than or equal to 80%.

Although we cannot guarantee you a job if you enroll in our GCP courses, we believe that by doing so, you are providing yourself with a great opportunity to advance in your career by expanding your knowledge and skill set and staying current with industry developments. Furthermore, upon course completion, you will have the option to print the GCP course certificate, which includes all the reviewed topics.

You should include your GCP training in your work portfolio to demonstrate your knowledge to prospective/current employers.

If you sign up for our newsletter, you will see discounts being sent out periodically for single users.

We offer discounts for more than five accounts, so please get in touch with us to discuss a discount if you need to buy a course for multiple users.

Yes, please contact us to discuss your team needs.

Select a course and purchase it. You can pay online via our secure Stripe’s payment gateway, using your preferred card, at no extra cost. The system will automatically create you an account, and you will be able to start your training. 

If you have a discount code, you must complete the course registration process as usual. Then, when you get to the screen where you have to enter your information and make payment, there will be a field where you can enter a discount code, if any. If the code worked, the course’s price will be updated to reflect the new discounted price.

Then, proceed to sign up as usual, entering all of your information.

It means that it is flexible enough to allow you to start and stop from any device whenever you like, and the system will automatically save your progress. To support the lifelong learning of our researchers, we provide lifetime access to our course resources.

Yes, we keep track of all of our users and the dates on which they took our course. You, or your employer, may contact us at any time to confirm the validity of your certificate.

We want you to be completely satisfied with your course; therefore, we offer a 30-day money-back guarantee if you are not 100% satisfied.

To request a refund, you should email us at contact@pharmaeducenter.com with proof of purchase and evidence of the course not being as advertised or any issues you have accessing or completing your course.

Please note you must not complete the course or print your certificate in order to make a valid refund claim.

ICH GCP E6 R3 Good Clinical Practice training for investigators and site personnel — TransCelerate recognized online course

This course includes:

  • 🎓 Official ICH GCP certification
  • ♾️  Lifetime access
  • 📊 Automated progress tracking
  • 💰 Discounts for teams

🛡️30-day money-back guarantee 

100% Secure Payment 🔒

Guarantee Good Clinical practice training and Certification

 

30-day money-back guarantee: Try the full course risk-free. If you’re not satisfied before completing it, we’ll refund you, no questions asked.

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