The ATTC network has recently produced an ATIMP Protocol Guidance Document to aid in the writing and development of ATIMP specific protocols for trial delivery within the UK, and is composed of guidelines and recommended reading specific to key protocol sections nuanced to ATIMP trials. This was developed in collaboration with key bodies from across the ATMP UK landscape including the NIHR, NHS Research Scotland (NRS), Health and Care Research Wales (HCRW), Specialist Pharmacy Service Pan-UK Pharmacy Working Group for ATMPs, an Industry Advisory Group overseen by Cell and Gene Therapy Catapult, Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA). This document is intended to be used in conjunction with a protocol template (e.g., The Health Research Authority (HRA) protocol template)) and aligns with relevant regulatory guidelines.

The document is housed within our NHS Readiness Toolkit; as a guidance document this can be located within the ‘National Infrastructure, templates and guidance’ section of the Clinical Trials area.

Please follow this link to access the document directly: ATIMP Protocol Guidance Document