What is it? Why is it important?
In order to guarantee the correct preparation, conduct and completion of a study, requires that key study players know and follow the Good Clinical Practice (GCP) guidelines.
GCP knowledge is confirmed through the attendance of a swissethics approved GCP course. A GCP course:
- Is mandatory for SP-INVs and Site-INVs
- The GCP certificate is included in the EC and Swissmedic submission dossier
The validity of a 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?
As a SP-INV and Site-INV:
- Be familiar with swissethics recognised GCP courses
- Attend a GCP course and obtain a recognised GCP certificate
- Ensure study staff has adequate GCP knowledge
- Ensure GCP principles are complied with during study planning and conduct
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
Swissethics – see in particular
- Training / GCP courses