If the lead site was approved before the submission changes, do they need to submit anything when a new site is added?
The lead site only needs to choose a pathway. There may be some situations where updated documentation is required, but it should be rare.
For example, if they pick pathway 2, they do not need to send in site-specific clauses documents if we have already approved their site-specific PICF. Sites approved before the PICF pathways only need update the HREC with a site-specific clauses document if they are changing the wording from an already HREC approved site-specific PICF.
If the lead site chooses pathway 3, the only update required is if the Master PICF does not cover the requirements of the additional site that is being added. E.g. the radiation statement has two options, but the new additional site has different wording that isn’t already covered. The lead site would then need to submit an amendment with an update to the Master PICF. The amendment can come either before or after the additional site is approved. If it comes post-approval, the additional site will be delayed in creating its site-specific PICF. This is a matter for Sponsors and sites to work out what suits them best.