What is Electronic Investigator Site File (eISF)?

  • eISF is a web-based platform that investigational sites can use as a replacement for the typical paper-based Investigator Site File (ISF) for a clinical trial

  • Sites can choose to use their own eISF or the Sponsor-provided eISF

  • When a site utilizes Sponsor-provided eISF, they have full ownership of the contents just as they do when managing essential study documentation via a paper binder

  • We are working with Florence as our eISF vendor

  • We are offering the use of eISF at no cost to the sites

Key features of Florence eISF to aid research sites:

  • Simple site account set-up process
  • Intuitive navigation and document management
  • Compliant eSignatures available within the platform
  • Audit trails
  • Long-term Archive

Potential benefits for research sites utilizing eISF

  • Cost-effective and minimizes site document storage costs
  • Removes paper burden for managing essential documents (no need to print or scan), allowing sites to focus on what matters (such as patient visits)
  • Green solution – reduces use of paper
  • Easy to search and locate documents and pending actions (tasks and signatures)
  • Availability of eSignatures for site staff
  • Remote monitoring of the site file. Source documents can also be shared in eISF if allowed, per local regulations
  • 25-year electronic archiving

Supplier Information

Website

florencehc.com

Contact

Florence@Merck.com

Reference Materials

What to Expect

eISF One-Pager

Benefits to sponsor eISF

User-friendly

  • eSignature capability is easy to use
  • Intuitive navigation
  • Secure single reference for all internal site users. Access only requires an internet connection – no need to install anything and can be accessed from mobile devices

Site convenience

Our company will provide an inspection-ready binder to the site (prior to site ready) containing all study, country and site-level documents, which will reduce filing work for the sites.

Monitor access can be managed centrally

Sites can turn off access if preferred and limit to monitoring visits, but we encourage continuous access for real-time visibility into the binders.

Overall Benefits

  • Search functions, workflows, and tools help ease administration burden on sites
  • Familiar Binder structure: Same folders as paper binders and are easy for sites to navigate
  • Sponsor can provide documents at any stage of the trial via Sponsor Inbox
  • Compliant with long-term archival requirements, which reduces storage burden
  • Offered at no cost to all sites
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