What is it? Why is it important?
In order to guarantee the correct preparation, conduct and completion of a study, requires that players with study responsibilities comply with Good Clinical Practice (GCP) guidelines.
GCP knowledge is confirmed through the attendance of a swissethics approved GCP course. A GCP course, including its certificate, is mandatory for SP-INVs and Site-INVs. A valid GCP certificate is included in an Ethics Committee (EC) application- and Swissmedic application dossier.
The validity of a swissethics approved GCP course has no limitation, unless swissethics revises learning objectives due to GCP revisions.
Swissethics strongly recommends to maintain GCP knowledge on an ongoing basis by:
- Performing research activities in different settings (e.g. increase knowhow on how to conduct studies)
- Attending GCP refresher courses, including other research related training courses
- Having the study site subjected to a GCP inspection (e.g. Swissmedic)
What do I need to do?
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
Swissethics – see in particular
- Training / GCP courses