Guidance to support and promote consistent pharmacy costing for commercial clinical trials involving ATIMPs.

Purpose

Clinical Trials involving Advanced Therapy Investigational Medicinal Products (ATIMPs) are complex.  The NIHR interactive Costing Tool (iCT) is a template used for costing clinical trials. As the number of ATIMPs increases, standardisation regarding the use of the iCT is necessary to facilitate the set up of clinical trials, providing clarity to sponsors and users alike.

The Clinical Trials subgroup of the Pan UK Pharmacy Working Group (PWG) for ATMPs, working together in collaboration with other stakeholders, have identified a need to develop this guidance to facilitate both NHS sites and industry partners on the use of the current NIHR secondary care tariffs relating to ATIMPs in order to provide transparency and standardisation across UK.

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