Basic↦Ethics and Laws↦Guidelines↦Good Clinical Practice
What is it? Why is it important?
The International Council on Harmonisation Good Clinical Practice (ICH GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting studies involving human participants.
ICH GCP standards provide public assurance that:
- The rights, safety, confidentiality and well-being of study participants are protected
- Study data and reported results are accurate and credible
Important ICH GCP aims are to:
- Provide unified standards in order to facilitate the mutual acceptance of studies by different RAs (e.g. Switzerland, EU, US, Japan, Australia, Canada, Nordic countries, WHO)
- Ensure principles retain their origin and are consistent with the principles defined in the Declaration of Helsinki
ICH GCP guidelines do not apply to Medical Device studies. For MD studies ISO1455 standards apply.
What do I need to do?
Comply with ICH GCP guidelines when planning studies that require initial EC/RA approval.
GCP should be read in conjunction with study relevant ICH guidelines, such as:
- E2A Clinical safety Data Management
- E3 Structure and Content of Clinical Study Reports
- E7 Studies in Support of Special Populations, Geriatrics
- E8 General Considerations for Clinical Studies
- E9 Statistical Principles for Clinical Trials
- E11 Clinical Investigation of Medicinal Products in the Paediatric Population
Both the SP-INV and the Site-INVs are required to provide proof of GCP training (e.g. in some instances relevant study staff are also required to acquire a GCP certificate).
In order to fulfil GCP requirements:
- Attend a swissethics approved GCP course
- Complete ICH GCP training courses based on whether you are a Site-INV or SP-INV
- File individually issued GCP training certificates in the study TMF/ISF
- GCP guidelines are not mandatory for HRO studies, but are highly recommended
- CTUs offer swissethics approved face-to-face GCP training courses, including GCP-refresher courses
- GCP online training courses are available. Prior to signing-up ensure these courses are approved by swissethics
- Only trainings certificates obtained after 01.01.2014 are considered valid
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 / List of swissethics recognised research ethics and GCP course providers
- Training / For investigators / Guidance for researchers regarding ethics and GCP training
- ICH E2A Data management
- ICH E3 Clinical study reports
- ICH GCP E6(R2)
- ICH E7 Special populations, geriatrics
- ICH E8(R1) General considerations
- ICH E9 Statistical principles
- ICH E11 Paediatric population