CTU Bern

GCP Refresher for clinical research

Course objectives

This course is aimed at providing a refresher training to clinical investigators with the essential knowledge of Good Clinical Practice (GCP) and of other regulatory and ethical requirements, and the skills for contributing to clinical trials.

Course content

The GCP Refresher is a half-day compact course and divided into four parts. The course can only be attended as a whole:
Part 1: consists of the basic principles and study project required documentation.
Part 2: addresses study preparation and conduct.
Part 3: continues on study conduct and project closure.
Part 4: is kept flexible and will address additional learning contents such as upcoming regulatory changes or key topics in clinical research.

Important Information regarding revised Clinical Trials Ordinance and the ICH GCP Guidline E6

Final versions of the revised Clinical Trials Ordinance and the International Council for Harmonization Good Clinical Practice guideline (E6) are expected to be publicly available in the next months. Once they are available, we will announce new additional dates for GCP Refresher courses. The next courses will then focus on these revisions. Further information on the revision projects can be here (FOPH) and here (ICH in section “E6 Glood Clinical Practice – E6(R3) EWG Good Clinical Practice (GCP)”).

Dates

  • Monday, 9 September 2024, 9.00-12.00, online via zoom

Course fee

CHF 120

Registration

Please register for the courses in 2024 with your credit card here. Registration is possible until one week before course start.

A minimum of 15 participants is required for the course to commence.

Certificate

In order to obtain GCP Refresher course certification, you are required to register individually with your full name and attend the entire course, i.e. attend all four parts in full length.
Please note, that for the issuance of a course certificate your personal data will be recorded in an electronic database. Your data will be treated confidentially and only used for internal purposes.
For more information please refer to the course flyer:

Language

The teaching language is English. Discussions are in English or German.