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ICH GCP E6 (R2)

Home / Trainings and events / ICH GCP E6 (R2)
This course is part of the "GCP Mutual Recognition Program" and is therefore accredited by TransCelerate BioPharma Inc. The Patronage of Transcelerate aims to standardize the GCP training for Research Teams and ensures that your chosen course meets the basic requirements for the GCP course.

Topics of this session

  • Principles of Good Clinical Practice
  • Regulatory Bodies
  • Responsibilities of the Investigator
  • Responsibilities of the Sponsor
  • Randomization procedures and unblinding
  • Study Documentation
  • Protocol Compliance
  • Investigational Medical Product
  • Informed Consent
  • Monitoring of Clinical Trial
  • Patients’ Safety
  • Progress Reporting
  • Premature Termination / Suspension of a Trial
  • Quiz

Click the link below and fill in your contact details, including billing information. You will receive an e-mail to sign in to the Labquality PRO learning platform. You can choose the language of the training platform (EN/FI/SV/ET/ES/RU). The training course is in English. The course is available for 90 days during which the whole course, including the quiz, must be completed.

The instructions and course material are delivered in electronic format on the Labquality PRO platform. Please read through the whole course material before taking the quiz at the end.

The quiz is composed of 15 questions, and there is a 15-minute time limit to complete the test. You will need to get right 80% of the questions to pass. You can try the quiz three times. After the successful completion of the quiz, the certificate will be generated automatically for you. Please note that the certificate is granted by Clinical Consulting Sp. z o.o., part of Labquality. Your certificate will be valid for 3 years or until there is an update to ICH GCP. Labquality will keep a register of those who passed the certification.

Trainers

No trainer
No trainer

This online course is designed for independent study.

Target group

Our ICH GCP online course is designed for students, medical practitioners, nurses, and clinical research professionals seeking to gain their first or to refresh their GCP certification. Whether you're pursuing a career in healthcare or already working in the field, our course provides a comprehensive overview of Good Clinical Practice guidelines. Stay updated with the latest requirements, ethical considerations, and best practices in clinical trials. Enhance your knowledge and maintain compliance with ease through our convenient online platform.

After this session, you

will acquire knowledge in the following areas:

  • Principles of Good Clinical Practice
  • Role of Regulatory Bodies
  • Responsibilities of the Sponsor and Investigator
  • Basics of maintaining source documentation
  • Informed Consent Process
  • Monitoring of Clinical Trials
  • Safety Reporting

Notice

This course has been written by MPharm Anna Kobielska-Kozik, a clinical trial professional with experience in medical products and medical device studies, both commercial and academic. Involved in the start-up, contracting, training, and monitoring processes of the sites and the preparation of study-related documentation.

Billing and cancellation policy

Read the billing and cancellation policy for online trainings here.

Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.

Cancellations are always made in writing to: koulutus@labquality.fi.  
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to:  koulutus@labquality.fi. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event.  Labquality reserves the right to cancel the training session due to a small number of participants.

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