Clinical Investigation Plan training

Fraunhofer AICOS can provide your team with training on preparing the Clinical Research Plan for the clinical investigation of medical devices. This document is essential for researchers at research centres throughout the study and is mandatory in submission to CEIC and Infarmed. We will present its parts, namely, the rationale, objectives, design methodology, monitoring, conduct, record-keeping, and the method of analysis for the clinical investigation, as well as the potential risks to subjects or third persons after risk minimisation and a risk-benefit analysis that CEIC and Infarmed will assess as to whether approve the study.