Clinical Trials

Clinical Trials

This section has a range of resources which will assist NHS sites to prepare for the set up and delivery of advanced therapy clinical trials; its objective is to disseminate learnings from the ATTCs regarding the governance, infrastructure and processes which underpin successful trial set up and delivery.


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ABPI Roadmap

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
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Advanced therapy investigational medicinal product (ATIMP) clinical trials – eLearning Module

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.

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All CAR-T follow up checklist

CAR-T follow up checklist
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Apheresis Training and Competency Manual

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

A template of an apheresis weekly cleaning log.
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ATiMP Clinical Trials Quality Technical Agreement Guidance

A guidance document providing an oversight of the purposes and contents of a Quality Technical Agreement (QTA) for use between advanced therapy clinical trial Sponsor and Participating Organisation. The document set outs a proposed standardised format for advanced therapy clinical trial QTA with example roles and responsibilities.
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ATIMP Feasibility Questionnaire FAQ Database Template

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

Governance structure organogram for supporting the introduction of ATMPs at the Christie Hospital
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ATMP Pharmacy Gene Therapy Presentation

A presentation on ATMP Pharmacy Gene Therapy treatments.
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ATMP Risk Assessment

Risk assessment form that is the basis for assessment of capacity and capability within Manchester University NHS Foundation Trust.
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ATMPs in paediatric haematology – Webinar

A look at some of the recent impacts of ATMP treatments on children at the Royal Manchester Children's Hospital
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ATMPs on the horizon – Webinar

Focussing on four upcoming ATMPs in 2021, how they work, how patients might benefit, how they are given and other practical issues staff need to aware of.
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ATMPs Pharmacy Training Session

PowerPoint presentation for an educational seminar on ATMP pharmacy.
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Basics of Gene Therapy – Webinar

This is a training webinar that covers the basics and introduction of in vivo gene therapy
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Cell and Gene Therapy Insights Paper on Best Practice in Flow Cytometry

This paper highlights the major themes found in designing and applying flow cytometric analysis for cellular therapies and discusses practical solutions to common problems