Course descriptions

A description of the GCP training courses follows:

Day 1: Principles of GCP, Investigator Responsibilities, Essential Documents is suitable for those starting work in clinical trials or serves as an in-depth refresher course for others with experience. It is open to all members.

Day 2: Principles of GCP, Sponsor Responsibilities, Ethics Committees is suitable for those who have already attended Day 1. It focuses on topics in ICH GCP other than investigator responsibilities and is necessary for those working on investigator-led trials. It is open to all members.

Day 3: GCP Audit/ Regulatory Inspection preparation is suitable for those who have already attended Day 1 and Day 2. It focuses on audit/ inspection processes, common findings, audit readiness and preparation tips. It is open to all members.

The audit/ inspection preparation course is generally held every session if there is sufficient demand.

Refresher GCP training lasting one hour is offered at every ICORG Group meeting (4 times per year). The refresher GCP course (which does not replace full GCP training) is required for all working on ICORG clinical trials every 2 years. It provides an introduction to or a re-cap on ICH GCP Principles, Investigator Responsibilities with tips on how you can comply with the requirements.