Requirements

• Original protocol and all amended versions
• Date all versions
• When applicable, a copy of the fully executed protocol signature page for original protocol and all amended versions

FAQs

Q: Do I have to keep outdated versions of the protocol in the Regulatory Binder?

No. You can keep outdated protocol versions either in a separate location or stored electronically (include version date in title). Write a signed and dated note-to-file indicating where previous versions are kept and file this in the binder

Useful Links