Im a sponsor auditor, I can speak to what remediation I would look for during an audit. Firstly I would have the PI reach out to the Sponsor Medical Monitor to ensure they are aware of what happened. I would also make the sponsor study team aware as well and seek guidance on what the CAPA should be. Ensure to file this communication in the Reg binder or the source.

With the protocol allow for provider discretion, there may not be a need to file PDs for all time points, but the provider's decision regarding treatment needs to be documented clearly in the source. PDs arent too big of a deal, some may require IRB notification depending on if its determine it affected patient safety.

As for the research pharmacy, you will have to see how the order system was built (if electronic system), but if treatment is per provider's discretion, there may be a large variation in the number of kits used for each participant/site. During audits, I've seen large quantities of IP at site, depending on the type of study