What is it? Why is it important?
The Good Clinical Practice (GCP) is an international ethical and scientific quality standard provided by ICH (International Council for Harmonisation).
Compliance with GCP standards provides public assurance that the rights, safety and well-being of study subjects are protected, and that study data are credible. In addition, it provides public assurance that standards are consistent with the principles that have their origin in the Declaration of Helsinki.
The ICH GCP E6 document address studies involving humans and gives guidance on how to design, conduct, record, and report clinical studies under ClinO.
In order to have the study approved by the Ethics Committee (EC), the SP-INV and applicable study staff, including any Site-INV(s) in a multicentre study, must submit proof of GCP training by providing an EC approved GCP certificate.
The World Medical Association (WMA) has developed the “Declaration of Helsinki” as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The document is regarded as a cornerstone on human research ethics.
What do I need to do?
Course requirements are as follows:
- The SP-INV must attend 2 GCP courses providing 2 separate certificates:
- GCP Investigator-level course certificate
- GCP Sponsor-investigator-level course certificate
- The Site-INV or other study relevant staff must only attend an investigator-level GCP course
When submitting your study to the Ethics Committe for approval, include all relevant GCP certificate(s) . Ensure GCP courses are approved by swissethics, as foreign certificates might not be accepted.
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 – in particular see
- List of recognised GCP course providers
ICH GCP E6(R2) – see in particular guideline
- Guidelines for Good Clinical Practice
Declaration of Helsinki – see in particular principles
- 9 Protection of research subjects
- 12 Qualification and training
ISO 14155:2020 Medical devices (access liable to costs) - see in particular
- “Education” key word
HRA – see in particular article
- Art. 10 Scientific requirements
ClinO – see in particular articles
- Art. 5 Good clinical practices
- Art. 6 Professional qualifications