Feasibility and risk assessments

XLSX

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.
PDF

ATMP Risk Assessment

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

Feasibility and risk assessment for all clinical trials

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

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.
PDF

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.
DOCX

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