Clinical research infrastructure will soon be enhanced with the addition of the electronic research document binder software, Florence eBinders.
Florence eBinders is a digital clinical trial site that houses workflow for electronic investigator site files, electronic participant binders, and electronic logs. Designed to help with clinical trial regulatory processing, the platform is meant for PI-initiated studies as well as industry-sponsored studies. It will be available to departments and personnel involved in clinical research.
Users will have remote access to regulatory documentation, files, logs, and binders for startup, monitoring, and source data review. Study-subject level binders can be created to share protected health information for source-data verification. The platform is 21 Code of Federal Regulations Part 11-compliant. These capabilities allow a complete digital experience – from startup to closeout – regarding clinical trials, including eSignatures.
The Office of Clinical Research is leading this effort in collaboration with Academic Information Systems, Human Research Protection Program, Sponsored Programs Administration, and various department and center representatives.
Go live for Florence eBinders is set for early fall. More information about role-specific training sessions will be communicated as they become available.
For questions, contact Andrea Taylor or Nora Tassabhji.
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