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Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155
Both the ICH GCP E6 Guideline and ISO 14155 address the elements of Good Clinical Practice in the design, conduct, recording, and reporting of human subject research. Although many sponsors of medical device studies use the ICH GCP E6 Guideline as an ethical and scientific quality standard, ISO is written specifically to protect the rights ...
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