Good clinical practice (GCP)

For devices, ISO 14155 is the GCP standard most often used. FDA accepts clinical data from studies outside the US when they were run according to GCP and the records support it.

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical studies that provides assurance that the data and reported results are credible and accurate, and that the rights, safety, well-being, integrity, and confidentiality of study subjects are protected.

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary