PI oversight of trials with central pharmacy

[RFay]

I would be grateful for guidance on a trial with central pharmacy that has received MHRA have approval. Our Trust has received a CTIMP to host where the IMP will be despatched directly to participants' from a central pharmacy that is contracted to the sponsor only. The sponsor will not involve our PI's pharmacy as we would normally expect. Our site pharmacy/PI will not be involved in the labelling or oversight of the IMP; one concern is that the label does not include allergy information that we would expect if IMP was managed by our site.

As a site we have no contractual oversight with the central pharmacy or courier, including drug accountability, storage, shipping and destruction. It is unclear whether the PI will receive monitoring reports of the IMP. Central pharmacy will not receive pt medical history or concomitant medications etc. on the prescription. The central pharmacy records will not be archived locally with the site file at the end of the trial. We have no contract with the courier that is shipping the IMP to our patients, only the site agreement with the sponsor.

We are unclear how we will demonstrate PI oversight of the IMP that is dispensed to our site's patients.

Please could you advise what would be expected of our site to comply with the CT regs?