Feasibility and risk assessments

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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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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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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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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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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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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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