The Clinical Trial Protocol module is a mandatory component of the Good Clinical Practice I – Investigator-Led training programme.
All participants enrolled in the Good Clinical Practice I – Investigator-Led course are required to complete this module and successfully complete all associated learning tasks, including the case-based exercises.
Authors
Samantha Chan
Content editors
Felix Rintelen
Education editor
Sharon Mitchell
At the core of the clinical trials process lays the investigational medicinal product (IMP). Successful studies rely on the quality and efficient, timely delivery of their clinical trial supplies. The EU Directive on Clinical Trials (2001/20/EC) requires that all commercial clinical trials must be conducted using Good Manufacturing Practice (GMP) compliant supplies. IMP should be manufactured, handled and stored in accordance with applicable GMP. In practice, the IML lifecycle involves 7 sequential steps: study and packaging design, label design and randomization, packaging, distribution, study conduct, returns and drug accounting and destruction.
Clinical trials on medicinal products are regulated under the Human Research Act (HRA), especially via the Clinical Trials Ordinance (ClinO). Swissmedic is the competent authority for medicinal products; swissethics is the body for ethics committee oversight. From 15 August 2025, Switzerland apply ICH GCP E6(R3) Principles and Annex 1.
The Clinical Trial Safety – Adverse Events module is a mandatory component of the Good Clinical Practice I – Investigator-Led training programme.
All participants enrolled in the Good Clinical Practice I – Investigator-Led course are required to complete this module and successfully complete all associated learning tasks, including the case-based exercises.
Completion of this module will help ensure that study personnel understand their responsibilities for the identification, classification, documentation, monitoring, and reporting of adverse events in accordance with protocol and regulatory requirements.
Authors
Kristina Stojkov
Content editors
Felix Rintelen
Education editor
Sharon Mitchell
Ux Design & content build
Priscillea Stettler-Kong