Advanced Therapies NHS Readiness Toolkit

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

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

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 of an apheresis weekly cleaning log.

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.

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

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.

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.

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

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

DLBCL CAR-T follow up checklist.

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

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

A guidance document providing an oversight of the purposes and contents of a Starting Material, Quality Technical Agreement (QTA) for use between customer and supplier. The document set outs a proposed standardised format for Starting Material QTA with example roles and responsibilities.

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.

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)

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

Initially set up to facilitate the onboarding of Wave 3 CAR-T centres in England, this template Technical Agreement produced by the Pan UK  Pharmacy Working Group for ATMPs is suitable for adaptation by NHS Pharmacies, when there is a requirement to outsource any aspect of cell or tissue based ATMP handling for ATMPs which hold a marketing authorisation.

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

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.

This webinar to showcases the Pan UK Pharmacy Working Group for ATMP’s pragmatic advice which clarifies the regulatory perspective regarding OOS ATMPs, and provides guidance to NHS organisations which are provider sites for ATMPs, about governance in the event of an OOS ATMP being supplied for one of their patients.

HSE (Health and Safety Executive) guidance to help organisations to choose the most appropriate regulatory procedure, particularly those wishing to undertake studies involving the administration to humans of substances based upon genetically modified microorganisms (GMMs)

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.

The HTA is the regulator for human tissue and organs, this includes activities using  human tissues or cells used as starting materials in the manufacture of ATMPs

A summary of the cellular therapy and transplant programme and the documents modified existing or created in order to deliver advanced therapies and comply with JACIE’s immune effector cell
standards

A presentation summarising the importance of JACIE regulation as applied to immune effector cell therapy

This SOP considers general principles for the management of a Class 1 or 2 GMO gene therapy spillage or accidental exposure in a clinical area.

A Pan UK Pharmacy Working Group for ATMPs resource to clarify the regulatory perspective regarding Out of Specification (OOS) ATMPs, and to provide guidance to NHS organisations which are provider sites for ATMPs, about governance in the event of an OOS ATMP being supplied for one of their patients.

An example risk assessment form to be completed prior to the use of genetically modified organisms (GMO’s) within a hospital

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

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

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.

An overview of what Datatrial’s electronic data capture (nowEDC) is, and how it can help aide the collection of data during clinical trials

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

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