Good Clinical Practice
The ISO 14155 addresses good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
When the GCP/ISO 14155 isn't followed from the beginning of a project, this will often result in delays in approval due to improperly designed studies, missing oversights, and other failures to meet key regulatory requirements.
The ISO 14155 specifies general requirements intended to:
- protect the rights, safety, and well-being of human subjects,
- ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
- define the responsibilities of the sponsor and principal investigator, and
- assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.