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Training overview

International Good Clinical Practice (GCP) online training


This 4-hour interactive online GCP course, is designed to meet all criteria and regulatory requirements of international regulatory bodies – FDA, MHRA and EMA. Upon successful completion users are issued an individual GCP certificate recognised by sponsors and CROs worldwide. Preview your certificate here or start a free trial in the FREE DEMO section below.

The course is created by top industry experts and is appropriate for all current and future clinical research professionals.

  • Interactive content, including video materials, and visuals, case studies
  • Learn at your own pace
  • Expert interpretation of GCP Regulations, including E6 GCP
  • 6 CPD points - International accreditation by the Royal Colleges of Physicians/Faculty of Pharmaceutical Medicine and TransCelerate Biopharma
  • Flexible administrative options for corporate clients
Certificates
Full training content

Module 1 – Introduction, History and Principles of ICH- GCP

  • Introduction
  • Brief History of ICH-GCP
  • Principles of ICH-GCP

Module 2 – Informed Consent Process, Documentation

  • Informed Consent Definition
  • Informed Consent Process
  • Informed Consent Document

Module 3 – Roles and Responsibilities according to ICH-GCP

  • IRB/IEC
  • Investigators
  • Sponsor-Vendor Responsibilities

Module 4 –Adverse & Serious Adverse Events

  • Detecting adverse events and serious adverse events
  • Attribution
  • Reporting of adverse events

Module 5 – Essential documents

  • Before a clinical phase
  • During the clinical phase
  • At trial termination or completion

Module 6- Drug Accountability & Compliance

  • Drug Compliance in Clinical Trials
  • Drug Accountability
  • How to Calculate Clinical Study Drug Compliance and Accountability

Module 7- Monitoring, Auditing & Inspection

  • Monitoring
  • Auditing
  • Inspection
Free DEMO

Please register for the free demo to take a closer look at the course and determine whether our interactive GCP training will match your needs. Enabled are portions of the content included in the genuine training package, so it feels exactly like the full version of the course. You can also access:

  • Videos
  • Case studies
  • Useful links
  • Documents

Demo training content:


Module 1 - Background and Principles

  • Introduction to GCP
  • Brief History of GCP
  • Declaration of Helsinki
  • Differences between WHO-GCP and ICH-GCP
  • Summary of Module 1 (Video)

Module 2 - Subject Protection

  • Definition of Informed Consent
  • Informed Consent process
  • Informed Consent Documents
  • Vulnerable Populations
  • Summary of Module 2 (Video)
Corporate Solutions and Certification
This training is also available as a corporate solution, which allows professionals with administrative functions, such as R&D, Training, QA, Clinical Operation, HR Managers, to manage and monitor the whole learning process/curve:
  • licences and access management
  • performance statistics and outcomes
  • certificate management
  • reports

The GCP training is also offered in the form of face-to-face training, where experts from our International Network of Trainers come to you; additional content customisations are available upon request.

Corporate Discounts
Number of accounts Cost (per account)
Price in
EUR
Price in
GBP
1-15 80.5 64.00
16-30 74.00 59.00
31-50 69.00 54.00
50+ Please, contact us.

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