eProtocol

No, the site does not reference the version and date. The site only needs to reference which document their wording is going into (e.g. Master Main, Master Pregnancy).

If the lead has chosen pathway two, and each site has submitted a site-specific clauses document, if they never wish to change any ethical content in their site-specific PICF, we will never receive an update to that document for the rest of the study.

The clauses document is approved, and each time the Master is updated, they include their approved clauses in their site-specific version, which is approved via whatever mechanism they choose for their own site (e.g. Clin Trial Manager go-ahead, CRO sign off etc).