Course details

Cancer Trials Ireland’s Training and Quality unit delivers two GCP Training Courses; the Full Day Introductory GCP training course and the Refresher GCP training course.

We also offer ICH GCP training via the ICON Firecrest online GCP portal to all investigational site staff.

From time to time and depending on demand, we will hold the GCP Audit/ Regulatory Inspection preparation course which is suitable for those who have already attended the full day GCP course and have some experience in clinical trials. The course focuses on audit/ inspection processes, common findings, audit readiness and preparation tips and is open to all members.

Full Day Introductory GCP training course

This course covers the following:

  • Introduction to ICH GCP
  • Principles of ICH GCP
  • Investigator Responsibilities
  • Sponsor Responsibilities
  • Essential Documents
  • Workshops throughout
  • Knowledge Assessment

This course is suitable for those starting work in clinical trials or serves as an in-depth refresher course for others with experience.

The course is open to all members. Pre-reading of the GCP guideline is required before attendance and there are plenty of workshops to help participants learn ways in which to comply with the requirements.

Refresher GCP training course

This course is offered during every Cancer Trials Ireland face-to-face DSSG meeting (twice a year) and takes about one hour.

The refresher GCP training course (which does not replace Full Day GCP training course) is required for all working on Cancer Trials Ireland clinical trials every 2 years.

It provides an introduction to or a re-cap on the following:

  • Principles of ICH GCP
  • Investigator Responsibilities
  • Resources (Staff/ Patient Recruitment)
  • Training/ Delegation
  • Protocol Compliance
  • Informed Consent
  • Management of Investigational Product
  • Essential documents
  • Safety reporting
  • Knowledge Assessment