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?

[a123456]

Useful references to read:-
EMA EC HMA RECOMMENDATION PAPER ON DECENTRALISED ELEMENTS IN CLINICAL TRIALS 13 Dec 2022

FDA Decentralized Clinical Trials for Drugs, Biological Products, and Devices Guidance for Industry, Investigators, and Other Stakeholders DRAFT GUIDANCE May 2023
FDA draft might be useful:-
“A central distribution service could be used to ship the IP directly to trial participants. The investigator or delegated trial personnel must control the release of the IP by the distributor; monitor receipt and use by trial participants (or participants’ legally authorized representatives), according to procedures described in the protocol; and monitor the return or disposal of any unused product as directed by the sponsor.
The protocol should describe how investigators will track and document that trial participants (or participants’ legally authorized representatives) receive IPs. “


You might find this EMA Q&A useful:-
https://www.ema.europa.eu/en/human-r...l-practice-gcp
“The investigator should retain the final decision on whether the service provider, intended to support the investigator, is appropriate. The investigator also retains the ultimate responsibility for any tasks involving trial-related medical decisions (e.g. participant eligibility and enrolment, protocol specified medical procedures, assessment of efficacy/safety, evaluation of test results, decision to dispense or make changes to the trial medication) and, the appropriate supervision of the persons or parties undertaking the activities delegated.
Any trial related procedure that is delegated to a service provider should be specified in a written agreement. Where the agreement is between the sponsor and the service provider and involves tasks under investigator responsibility, it should be clear in the agreement between the sponsor and the service provider as well as in the agreement between the sponsor and the investigator that the investigator maintains adequate control and oversight over the contracted tasks.”