Trial Innovation Network - Investigative Site File (ISF) Reference Model: Easing the Burden of Regulatory Binders for Sites and Sponsors

Monday, April 1, 2019 - 12:00pm to 1:00pm
Event Details: 

The identification and organization of the clinical investigator site files required to be managed under ICH E6 have been handled in non-conforming practices. As clinical sites move to an electronic regulated content management system, these efforts would benefit from a best practice. Bridging paper to electronic files would help sites learn the benefit and further the adoption of compliant electronic management of clinical files.

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