Local pharmacy review of research studies

Guidance documents have been created to support the transfer of information between Pharma/Contract Research Organisations (CROs) and NHS Pharmacies to support smooth set up and delivery of studies.

When a clinical trial involving an Investigational Medicinal Product (IMP) is hosted in or through the NHS, a local pharmacy review on behalf of the NHS organisation providing care, is conducted before NHS permission is granted. This is for the following reasons:

  1. The pharmacy review forms part of the local governance check. Trial activities are reviewed to ensure that there are adequate arrangements and resources (the capacity and capability) within the pharmacy department to support the requirements of the trial.
  2. The information provided to complete the review allows a local financial review and any significant cost discrepancies to be considered and resolved.
  3.  The Chief Pharmacist or another nominated deputy often has the delegated responsibility for IMP management and accountability within the organisation. Prospective trial activities will be reviewed to enable compliance
  4. Pharmacy staff use this information to continue the development of set up activities which in turn ensure effective setup and delivery

Guidance and FAQs on information requirements for local pharmacy review of research studies

The Guidance Document outlines the detail of what NHS pharmacy require from Sponsors / CROs to enable a timely local pharmacy review process to occur, resulting in trial preparation / set up with the overall one set of information requirements.

The guidance document was piloted over 20 NHS sites with more than 100 studies and is now available for NHS organisations and Sponsors /CROs to use.

 

Sponsors/CROs Pilot – next phase

In order to continue to confirm its fitness for purpose and to gain additional feedback from users we ask commercial sponsors to monitor the impact of the guidance document in use. To accomplish this, Pharma/ CROs are invited to participate in the next phase of the pilot by choosing studies on which to test the guidance document.