Development↦Management↦Responsibilities↦Good Clinical Practice Training
What is it? Why is it important?
Good Clinical Practice (GCP) is an international ethical and scientific quality standard provided by ICH (International Council for Harmonisation).
The Efficacy Guideline E6 document gives guidance on how to design, conduct, record and report clinical studies involving human subjects.
GCP compliance provides assurance that the rights, safety, and well-being of study participants are protected.
In order to receive EC approval for the study, the SP-INV and if applicable Site-INV and other study staff must submit their GCP training certificates.
For studies with medical devices, the ISO 14155 is the required guideline.
Standards are consistent with principles that have their origin in the Declaration of Helsinki.
What do I need to do?
Attend a swissethics recognised GCP course.
Course requirements are as follows:
- The SP-INV must attend 2 GCP courses providing 2 separate certificates:
- GCP Investigator level
- GCP Sponsor-investigator level
- The Site-INV or other study relevant staff must only attend the GCP course for investigator level.
For medical device studies, it is highly recommended to attend an ISO 14155 training.
Include all relevant GCP certificate(s) when submitting your study to the applicable EC. Ensure GCP courses are approved by swissethics, as foreign certificates might not be accepted.
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 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.
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