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)”) to
The Federal Council approved amendments to ordinances related to the Human Research Act (HRA) and adopted them on 7 June 2024. The amendments strengthen the protection of persons participating in research and—where possible—improve the regulatory framework for researchers. The amended ordinances enter into force on 1 November 2024, with the exception of the provisions on transparency, which enter into force on 1 March 2025.
The amendments to the four ordinances accompanying the HRA adopted on 7 June 2024 introduce a number of improvements and adapt the provisions to technological, scientific and societal changes and international developments.
DCR's upcoming GCP courses contain content about the amendments to the ordinances in the curriculum from 20 August 2024–forward.
Please read the UPDATE: New implementing regulations apply as of 1 November 2024 from swissethics for more information: https://swissethics.ch/en/news/2024/07/15/update-new-implementing-regulations-apply-as-of-1-november-2024.
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.