The NIHR Clinical Trial Routemap is an interactive colour-coded tool to help navigate through the legal and good practice arrangements surrounding setting up and managing a Clinical Trial of an Investigational Medicinal Product (CTIMP). The routemap distinguishes between legal and good practice requirements, and indicates which aspects of these are relevant to wider clinical research in general. It includes an overview of trial practices, along with more detailed information available at ‘stations’ along the route.

This Roadmap Tool sets out the key steps and activities in the end-to-end pathway for Advanced Therapy Medicinal Products (ATMPs) in England from non-clinical research through to treatment provision & monitoring

A proforma for submission to the Manchester Clinical Research Facility (Christie site), which outlines NHS Trust clinical and resource requirements, prior to study set up.

A template produced by The Christie NHS Trust to hold and update frequently asked questions and responses to cell therapy trial feasibility questionnaires.

A proforma outlining considerations for an NHS Trust prior to commencing a cell therapy / immune effector cell trial.

Risk assessment form that is the basis for assessment of capacity and capability within Manchester University NHS Foundation Trust.

Template for the feasibility and risk assessment of all clinical trials (not just ATIMP)

Terms of Refence for the Research and Innovation ATIMP Board (a sub-committee of the ATMP board) at The Christie Hospital Manchester. Included are aspects such as the boards powers and membership.

An example risk assessment used to fully review the risk posed by GTMP/GTiMPs in preparation for submission to local genetic modification safety committee

Exemplar terms of reference for an ATMP Education and Training Committee at The Christie NHS Foundation Trust

Governance structure organogram for supporting the introduction of ATMPs at the Christie Hospital

This training webinar gives an overview of the preparations required prior to treating patients with ATMPs

The objectives of this SOP are to ensure products are correctly and consistently labelled to ensure the positive identification of each harvest and facilitate cell chain to track from donation to reinfusion. For products transferred to areas outside the Clinical Apheresis Unit, and those reinfused within the transplant programme.

Nursing assessment form pre-apheresis.

CAR-T checklist proforma for admissions and apheresis, with MDT communication sheet.

An SOP outlining the procedures for the coordination and delivery of adoptive cellular therapy within The Christie NHS Foundation Trust.

This SOP aims to ensure that proposed trial protocols, requiring access to Cellular Therapy and Transplant Programme services, are reviewed by the appropriate staff prior to being authorised to open.

A template of an apheresis weekly cleaning log.

SOP regarding the maintenance of a safe environment in a Clinical Apheresis Unit of an NHS hospital.

Training package to prove nurses with knowledge, skills and expertise to perform specific apheresis procedures for cellular therapy in a safe and professional manner.

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an overview of the procedural requirements for the procurement of human tissues and cells but does not discuss in depth the consent and ethics requirements

The purpose of this document is to provide clear guidance on the procedures to be followed during the processing of ovarian tumour tissue to establish a) a tumour infiltrating lymphocyte culture; (b) an autologous tumour cell culture; (c) a cryopreserved aliquot of tumour culture digest; (d) subsequent cryopreservation of TIL and autologous tumour cultures for future assays.

SOP to ensure all nursing and medical staff involved in the infusion of cellular products are aware of their responsibilities, the procedure and any action to be taken in the event of adverse reactions or incident.

This guidance produced by the Pan UK Pharmacy Working Group for ATMPs describes the legal basis for associated activity and provides guidance for Pharmacy clinical trial sites who may need to outsource these services.  The information provided will guide Pharmacy trial sites in establishing appropriate partnerships and understand the regulatory position with regard to the activities contracted.

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an overview of the requirements for labelling human tissues and cells for use as starting materials for advanced therapy medicinal products using the ISBT 128 system.

This document sets out an example generic checklist for receipt and storage of fresh, autologous, cellular Advanced Therapy Medicinal Products.

This document can be used to help prompt consideration and recording of the competencies that are needed to work safely with dry shippers and/or dry ice.

Some ATMPs contain living cells. These cell-based therapies may be cryopreserved to extend their shelf life, requiring carefully controlled thawing prior to administration. Failure to thaw the product correctly may impair the integrity of the cells (viability and/or function) and the product may be rendered unfit for purpose. This document describes and example procedure for thawing cryopreserved ATMPs using a water bath.

This document sets out an example generic checklist for transfer of shippers containing Advanced Therapy Medicinal Products (ATMPs) to clinical areas, and their return to the sending laboratory.

This document sets out an example generic checklist for receipt and storage of fresh, allogeneic, cellular Advanced Therapy Medicinal Products

This document sets out an example generic checklist for autologous, cryopreserved, cellular Advanced Therapy Medicinal Products (ATMPs)

This document sets out an example generic checklist for allogeneic, cryopreserved, cellular Advanced Therapy Medicinal Products (ATMPs).

SOP to ensure all nursing and medical staff involved in the infusion of cellular products are aware of their responsibilities, the procedure and any action to be taken in the event of adverse reactions or incident.

This guidance produced by the Pan UK Pharmacy Working Group for ATMPs describes the legal basis for associated activity and provides guidance for Pharmacy clinical trial sites who may need to outsource these services.  The information provided will guide Pharmacy trial sites in establishing appropriate partnerships and understand the regulatory position with regard to the activities contracted.

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an overview of the requirements for labelling human tissues and cells for use as starting materials for advanced therapy medicinal products using the ISBT 128 system.

Advice produced by the Pan UK Pharmacy Working Group for ATMPs for Pharmacy sites on costings for clinical trials of ATMPs, using the NIHR interactive costing tool.

Guidance produced by the Pan UK Pharmacy Working Group for ATMPs regarding the operational implications of the UK exit from the EU for NHS Pharmacy clinical trial sites, including ATiMPs

Template for the feasibility and risk assessment of all clinical trials (not just ATIMP)

Guidance produced by the Pan UK Pharmacy Working Group for ATMPs, providing definitions of oversight and supervision and clarifies where each are required when implementing Advanced Therapy Medicinal Products

This document sets out an example generic checklist for receipt and storage of fresh, autologous, cellular Advanced Therapy Medicinal Products.

This document can be used to help prompt consideration and recording of the competencies that are needed to work safely with dry shippers and/or dry ice.

Some ATMPs contain living cells. These cell-based therapies may be cryopreserved to extend their shelf life, requiring carefully controlled thawing prior to administration. Failure to thaw the product correctly may impair the integrity of the cells (viability and/or function) and the product may be rendered unfit for purpose. This document describes and example procedure for thawing cryopreserved ATMPs using a water bath.

Policy and guidelines on the management of Cytokine Release Syndrome with cellular therapies (notably CAR-T cells) and bi-specific T cell engaging antibodies (eg blinatumomab).

DLBCL CAR-T follow up checklist.

SOP for safe discharge and follow-up for patients, post Chimeric Antigen Receptor (CAR) T-cell therapy infusion.

CAR-T follow up checklist

SOP to outline the framework and key aspects of training for pharmacists practicing within haematopoietic cellular therapies at The Christie NHS Trust.

Outline guide for management of inpatients receiving immune effector cells

Template proforma for medical assessment of patients for bone marrow harvest or therapeutic apheresis

SOP to ensure all nursing and medical staff involved in the infusion of cellular products are aware of their responsibilities, the procedure and any action to be taken in the event of adverse reactions or incident.

An example SOP from University Hospitals Bristol and Weston NHS Foundation Trust detailing effective shared care between the treatment centre and referring centre.

This example SOP considers general principles for the handling and administration of an example in vivo GMO gene therapy in a clinical area which can be adapted to accommodate local procedures or product-specific requirements.

Poster outlining the approach to developing an NIHR Clinical Research Facility which is safe for the delivery of Oncology ATMP trials.

SOP to outline the framework and key aspects of training for pharmacists practicing within haematopoietic cellular therapies at The Christie NHS Trust.

Training package to prove nurses with knowledge, skills and expertise to perform specific apheresis procedures for cellular therapy in a safe and professional manner.

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an overview of the requirements for labelling human tissues and cells for use as starting materials for advanced therapy medicinal products using the ISBT 128 system.

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an overview of the procedural requirements for the procurement of human tissues and cells but does not discuss in depth the consent and ethics requirements

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user a refresher of standard clinical trial studies and explains the additional features which impact on the design of trials for investigational advanced therapy medicinal products (ATIMPs) and how they can be addressed. Roles and responsibilities, governance and sources of support for ATIMP clinical trials are also outlined.

PowerPoint presentation for an educational seminar on ATMP pharmacy.

Slides from a pharmacy teaching session on ATMPs from Manchester University NHS Foundation Trust

A presentation on ATMP Pharmacy Gene Therapy treatments.

A training needs package and competency guide for healthcare and academic professionals involved in the delivery and direct care of patients receiving advanced therapy treatment; it provides information and signposting to external resources for independent training, learning and further reading on a number of key areas relevant to these medicines.

A UK Wide Survey of Current Referral Routes and Practices to Identify Gaps in the Referrals Process and Maximise Patient Access to Cell Therapy Clinical Trials

Summary of workshop findings re: barriers to effective ATIMP trial set up, changes required to overcome them and key ATIMP trial metrics.

The Health Research Authority’s online guidance for researchers and ethics committees on consent, and how to prepare materials to support this process.

Information provided by the European Medicines Agency (EMA) on the European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation, entered into application on 31 January 2022.

For new for new Clinical Trials of Investigational Medicinal Products (CTIMPs) and combined IMP/device trials. A step by step guide on how use use IRAS for a combined review.

Guidance on costing a clinical trial provided by NIHR.

Training and supporting materials provided by the European Medicines Agency (EMA) on how to use the Clinical Trials Information System (CTIS).

Government advice on how to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.

When applying for HRA Approval you will need to check what supporting documents you will need to provide well in advance of when you expect to submit your application. This will avoid unnecessary delays to your application. This page details the required supporting documentation.

UKCRF Network: Framework for conducting highest risk Phase 1 and Experimental Medicine Studies with NIHR CRFs and wider NHS Acute Trusts

The web-based interactive Costing Tool (iCT) provides a framework for transparent cost display and calculation to support swift local site budget negotiations when planning commercial trials in the NHS.

UK local information pack for participating NHS/Health and Social Care (HSC) organisations.