What actually moves

A regulatory binder, also called an investigator site file, holds the essential documents for a study: protocol versions, IRB approvals, delegation logs, training records, staff credentials and correspondence. An eISF keeps the same file electronically, so the contents don't change much. How your team finds, signs and maintains those documents does.

Get these right before you start

  • Ask first: check any sponsor or CRO requirements for an electronic file, and whether anyone needs to approve the change.
  • Write down your process: decide who files documents, who approves them, and how signatures work.
  • Decide what happens to paper: confirm how originals are handled and retained before scanning anything or changing how they're stored.
  • Check scanned copies: have a way to confirm each scan is complete and readable.

Start small

A new study is usually the easiest place to begin, because there's no back file to move. Once that's working, you can look at active studies one at a time. Use a consistent structure across studies, so staff and monitors know where to look.

What you should gain

  • A clear view of which document version is current
  • Early warning of missing or expiring documents
  • A delegation log kept close to credentials and training
  • Monitor review without a stack of paper

Not sure which file is which? Our guide to eISF vs eTMF explains who owns each one.

Where PAS OneCore fits

Our eReg and eISF software organizes each study into a binder with a completeness bar, and covers document versions, e-signatures, the delegation log and training records.

Ready to retire the binder?

Tell us what your regulatory files look like today, and we'll talk through where to begin.

Talk to us