Quality assurance and risk management

Quality assurance and risk management

This section provides examples of and guidance on the implementation of quality systems and risk assessments for safe delivery of advanced therapies towards preparing for regulatory inspections.

Back to all overview
PDF
14.07.2022

Aide Memoire – Procurement Site Qualification

A guidance checklist for NHS staff in preparation for ATMP starting material procurement site qualification. This document would be best utilised when beginning to set up a service for procurement of a new cell or tissue type but could be used as a checklist for existing cell or tissue type procurement
Open PDF
PDF
27.02.2023

All CAR-T follow up checklist

CAR-T follow up checklist
Open PDF
PDF
27.02.2023

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.
Open PDF
PDF
27.02.2023

Apheresis Weekly Cleaning Log

A template of an apheresis weekly cleaning log.
Open PDF
PDF
02.02.2022

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.
Open PDF
PDF
04.01.2019

ATIMP/ ATMP Vertical Audit

Questions to support and examine all aspects of the movement of this an ATMP/ATIMP through the process of being delivered to a patient and check for conformity to the process.
Open PDF
PDF
26.04.2019

ATMP Governance Structure

Governance structure organogram for supporting the introduction of ATMPs at the Christie Hospital
Open PDF
PDF
22.09.2022

ATMP Risk Assessment

Risk assessment form that is the basis for assessment of capacity and capability within Manchester University NHS Foundation Trust.
Open PDF
PDF
27.02.2023

Developing an NIHR CRF for safe delivery of Oncology ATMP trials

Poster outlining the approach to developing an NIHR Clinical Research Facility which is safe for the delivery of Oncology ATMP trials.
Open PDF
PDF
27.02.2023

Diffuse large B cell lymphoma (DLBCL) CAR-T follow up checklist

DLBCL CAR-T follow up checklist.
Open PDF
External link
31.03.2021

EMA Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products

The guideline describes specific aspects of pharmacovigilance, risk management planning, safety and efficacy follow-up of authorised ATMPs, as well as some aspects of clinical follow-up of patients treated with such products.
Go to link
PDF

eTMF Datasheet

An overview of what an Electronic Trial Master File is, and how it can help an organisation with their file organisation.
Open PDF
PDF

Example risk assessment for proposed activities involving; Gene Therapy Medicinal Products (GTMPs) or Gene Therapy Investigational Medicinal Products (GTIMPs)

An example risk assessment used to fully review the risk posed by GTMP/GTiMPs in preparation for submission to local genetic modification safety committee
Open PDF
PDF
22.09.2022

Feasibility and risk assessment for all clinical trials

Template for the feasibility and risk assessment of all clinical trials (not just ATIMP)
Open PDF
PDF
03.06.2019

GMO contained use authorisation procedures for clinical trial products in the UK

This guidance summarises the authorisation process for Genetically Modified Organisms (GMO) as Investigational Medicinal Products (IMP) for contained use (CU) within the United Kingdom (UK). These submissions are unique to GMOs, in addition to Clinical Trial Authorisation (CTA) and Ethics
Open PDF