In order to ensure the safety of study participants and high quality in clinical studies, professional knowledge and continuous compliance with national legislation and international standards, such as Good Clinical Practice (GCP), are required.
What is ICH-GCP?
The organisation "ICH (International Council for Harmonisation)" first published an internationally recognised Good Clinical Practice (GCP) guideline in 1996. This guideline defines principles that are now regarded as the globally accepted ethical, scientific and operational standard for human research. ICH-GCP has not only become one of the main references for the Swiss Human Research Act (HFG), but also forms the content basis for the nowadays obligatory training courses for investigators in clinical studies.
For whom are GCP courses mandatory or recommendable?
Swissethics (Swiss Ethics Committees for Human Research) defines the mandatory requirements regarding research ethics and GCP for researchers in clinical studies in Switzerland. These differ according to the GCP training level "investigator level" and "sponsor-investigator level", which is reflected in the GCP courses:
GCP basic course with swissethics recognised "investigator level" certificate
- Mandatory for investigators (according to Art. 2d KlinV) in clinical research (according to Art. 3l HFG)
- Recommended for all study team members in clinical studies (e.g. investigators, study nurses, study managers, study coordinators, monitors)
GCP advanced course with swissethics recognized certificate "sponsor-investigator level"
- Mandatory for investigators with sponsor responsibility (sponsor-investigator according to Art. 2 c and d KlinV)
- Recommended for all employees involved in clinical trials (e.g. investigators, study nurses, study managers, study coordinators, monitors)
GCP Refresher course with swissethics recognized certificate
- Recommended for investigators, investigators with sponsor responsibility and clinical trial staff who wish to refresh their GCP knowledge or are required to do so by industry or ethics committees
For how long is a GCP certificate valid?
In principle, GCP course certificates issued by swissethics recognized course providers after 2010 remain valid. The ethics committees can, however, ask researchers to take part in a GCP course again if they are of the opinion that the knowledge has not been maintained.
Note: Since May 2017, the integrated addendum to the ICH-GCP Guideline E6(R2) in applicable in Switzerland. Researchers who have a GCP certificate recognised by swissethics but have not completed a GCP course with the integrated addendum E6(R2) may be asked by the Ethics Committee to study the new guidelines. A version of the integrated addendum E6(R2) - with the changes highlighted - is available at www.ICH.org.
A German summary of the ICH GCP E6(R2) addendum can be found here.