Development↦Ethics and Laws↦Liability↦Good Clinical Practice
What is it? Why is it important?
ICH GCP is an international guideline for Good Clinical Practice (GCP), which provides ethical, scientific and quality standard for the conduct of human studies. Standards ensure that the rights, safety and well-being of study participants are protected.
Based on study type (e.g. ClinO) and risk-category, SP-INV, Site-INV, and relevant study staff require GCP knowledge. This is confirmed through the attendance of a swissethics approved GCP course (i.e. 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
A Swissmedic GCP inspection of a study can also be an important learning experience on how to comply and implement GCP standards.
What do I need to do?
- Be familiar with swissethics recognised GCP courses
- Attend a required basic GCP course, and obtain a recognised GCP certificate
- Attend a required advanced GCP course for study SP-INVs, and obtain a recognised GCP certificate
- Include GCP certificates in an Ethics Committee (EC) application dossier, and as applicable in a Swissmedic application dossier
- Ensure study staff has adequate GCP knowledge
- Ensure GCP standards are implemented and complied with during study planning, set-up, conduct, and completion
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
External Links
Swissethics – see in particular
- Training / GCP courses