Trial Governance

Feasibility and risk assessments

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xlsx
27/02/2023

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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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.
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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
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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)
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pdf
27/02/2023

Manchester CRF (Christie site) Research Application Form

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.
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pdf
27/02/2023

Research and Innovation Trial Feasibility proforma (IEC trial protocol review)

A proforma outlining considerations for an NHS Trust prior to commencing a cell therapy / immune effector cell trial.
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docx
22/01/2020

Risk assessment form – genetically modified organisms (GMOs) – contained use activities involving micro-organisms and cells

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

    Governance

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    This section is intended to assist NHS organisations to create or modify governance structures to permit the introduction of advanced therapies, encompassing all levels of governance responsibilities and reporting within hospitals.

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  • Business and financial planning

    Business and financial planning

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    The introduction of advanced therapies into hospital treatment pathways requires a significant financial investment in resources and facilities. Information available here will help organisations to develop the appropriate business and financial plans as they prepare to deliver advanced therapies.

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  • Quality assurance and risk management

    Quality assurance and risk management

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    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.

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  • Operational delivery

    Operational delivery

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    The documents in this section will assist in the implementation of new advanced therapy services in a clinical setting, supporting the transition of guidance into practice.  Documents include process and patient flow charts to map the treatment pathway and information on the in-hospital logistics requirements.

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  • Clinical practice

    Clinical practice

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    Information is available here to support the clinical practice of the delivery of advanced therapies to patients, including patient assessment, handling advanced therapies, product administration, infusion, treatment and monitoring and recording treatment and side-effects.

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  • Education and training resources

    Education and training resources

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    To safely deliver advanced therapies to patients, staff need to be trained in this new modality of therapeutic intervention. This section includes resources that enable staff to learn more about ATMPs including e-learning, facilitating face to face training and competency assessments, and materials to support patient education.

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  • Long term follow up

    Long term follow up

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    A regulatory feature of advanced therapies is the need for longer-term follow up than for other therapeutic modalities.  The information provided here speaks to the methods of data collection for extended follow up patients after treatment.

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  • Clinical trials

    Clinical trials

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    This section has a range of resources – split into 8 sub-sections – 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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