Reporting Digital Endpoint Deviations to Authorities
Reporting Digital Endpoint Deviations to Authorities How to Report Digital Endpoint Deviations from Wearables in Clinical Trials Introduction: Understanding the Regulatory Expectation As wearables and other digital health technologies (DHTs) become standard tools in clinical trials, regulators require that deviations involving these devices be documented, assessed, and reported with the same rigor as traditional protocol…
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