Clinical trials for ATIMPs are complex. The supply chain for these products is often atypical, requiring additional considerations over and above the requirements of more traditional IMPs. As more Sponsors become involved in running these trials, the information provided in Pharmacy Manuals is becoming more variable leading to a number of queries from each participating site resulting in delays in trial implementation.
This document is aimed at Clinical Trial Sponsors to aid them in compiling a Pharmacy Manual containing all sections expected by an NHS trial site. Due to the complexity of these novel treatments, there may be additional requirements, or some of the items listed may not be relevant. A Sponsor should use this document as a guide when compiling the Pharmacy Manual. The intention is that where these items have been considered by a Sponsor, it will reduce the number of queries from participating sites, and make the process of bring on a new site an easier process for both parties.
Guidance for Clinical Trial Pharmacy Professionals
Pharmacy staff are encouraged to share this guidance with commercial Sponsors of ATIMP Clinical Trials as early in the set-up process as possible (e.g. feasibility) in order to share the required level of detail and expected content to facilitate consistent implementation and avoid potential delay.
Where Pharmacy Professionals are employed in the role of Sponsor Pharmacy, they are encouraged to provide a comprehensive pharmacy Manual as per these guidelines.