Yes, if the lead selects pathway 2.

It is for the following reasons:

  • The sites are submitting it to confirm they aren’t making changes.
  • If there are ethical changes, then the RGO/other institutional representative has a point of reference that the HREC has reviewed the wording, and it is OK for inclusion. We hope that it can help with making the line clear between what is ethics and what is governance. Governance is then about adding administrative items (headers, footers, logos, local site complaints).
  • The real value in the document is post-approval. If the site is not changing any site-specific content, they are free to create a site-specific PICF on the same day as the Master is approved. Historically, they may have created it, but they would then need to submit it to the HREC and await approval. In discussion with sites, we found our former approach caused issues when a Master PICF had urgent safety updates, and sites were then waiting for their site-specific PICFs to be approved post Master.

When we audit a study, if we find ethical changes to the site-specific PICF that were not submitted in the site-specific clauses document, we will bring it to the PI’s attention. We recognise there is no clauses document for historical studies, so we would go by the previously approved site-specific PICF.