Regulatory Compliance for eConsent Tools in Clinical Trials: FDA, EMA, and ICH Guidelines
Regulatory Compliance for eConsent Tools in Clinical Trials: FDA, EMA, and ICH Guidelines How to Ensure eConsent Compliance in Clinical Trials: FDA, EMA, and ICH Guidelines As clinical trials increasingly shift toward decentralized models, electronic informed consent (eConsent) tools have become indispensable. However, their use requires strict adherence to global regulatory frameworks. This tutorial outlines…