Virtual Regulatory Binder: Protocols

Last revised: 


  • Current protocol and all previously approved versions
  • When applicable, include a copy of the fully executed protocol signature page for original protocol and all approved versions

QIU Tips / Additional Information

  • All protocol versions can be kept in a separate location or stored electronically. Include a signed and dated note-to-file indicating where previous versions are kept.
  • Version should be dated and/or numbered

Applicable GCP Sections: