Faster, smarter medical research. Schedule a demo This document provides details on an approach to re-use anonymous data from Investigator Initiated Studies (IIS) to fulfill MDR (PMCF) requirements D.L. ARTS | F.T. COLONNA Satisfying PMCF requirements by utilizing IIS data How Castor EDC can help you achieve MDR compliance WHITE PAPER January 2020Faster, smarter medical research. Schedule a demo Contents Background 3 Outline of the solution 4 Core dataset and clinical evaluation plan 4 Investigator Agreement and informed consent 5 T echnical specifications 6 Notified Body Reporting (Annex XIV-B Section 7) 7 Additional capabilities 8 ePRO 8 API device integration 8 Study Progress Dashboard 9 Contact 10 References 10 castoredc.com | 2Faster, smarter medical research. Schedule a demo

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