Corporate and individual online training solutions developed by top industry experts.
6 hrs
6 CPD pts
£59.00

Per Licence

Add to cart View Cart
Training overview

International Good Clinical Practice (GCP) online training


Astra Nova’s online ICH Good Clinical Practice (GCP) course is an interactive and complete training solution for individual and corporate users, who need to be introduced to the GCP regulations and guidelines or just need to refresh their GCP knowledge.

The training course is suitable for wide range of professionals and delivers all industry required GCP understanding and guidelines for implementing it.

Why take this course?

  • Interpretation and explanation of GCP Regulations
  • Interactive content, including video materials, and visuals, case studies
  • International accreditation by the Royal Colleges of Physicians/Faculty of Pharmaceutical Medicine - 6 CPD points
  • TransCelerate Biopharma recognised
  • Flexible administrative options for corporate clients
  • Internationally Recognised Certificate, suitable for newcomers and experience industry professionals
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
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 74.00 59.00
16-30 69.00 54.90
31-50 62.00 49.00
50+ Please, contact us.
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)
Certificates

Copyright © 2014, AstraNova Ltd. All Rights Reserved.