eRegulatory binder (eISF)

What does eRegulatory binder (eISF) mean in clinical research?

The investigator site file is the set of essential records a site keeps for each study: approvals, delegation and training logs, protocol versions, consent form versions and correspondence. An electronic investigator site file (eISF), also called an eRegulatory or eReg binder, keeps those records digitally. Florence Healthcare describes its eISF as allowing remote monitoring, document sharing, study management and compliance supervision in one place.^⁠[1]

Recruitment creates regulatory records too. ICH E6(R3) lists records that document the recruitment, pre-trial screening and consenting process of trial participants among a trial's essential records.^⁠[2] IRB-approved call scripts, text messages, advertisements and any AI disclosure language belong in the binder with their approval dates, next to the screening log.

Practical note: eISF platforms are now common; Florence says its eISF is trusted by more than 65,000 sites.^⁠[3] If a recruitment vendor produces logs or approved materials, agree up front how they will get into the site's eISF. Bond works alongside eRegulatory platforms such as Veeva SiteVault through export or API where the vendor supports it; see Implementation.