D 5. 1 Regulatory guidelines for clinical translation

Summary
Includes i Regulatory and ethical approval for a firstinhuman clinical trial of a medical device for intraoperative brain monitoring at the NHS Salford Royal hospital Manchester ii Design of the clinical trial protocol
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Web resources: https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5e2930939&appId=PPGMS
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