Phys. Description |
xxi, 580 pages : illustrations ; 19 cm |
Series |
Oxford medical handbooks |
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Oxford medical handbooks.
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Contents |
Research: why and how? -- Navigating research methods: basic concepts in biostatistics and epidemiology -- Navigating research methods: quantitative and clinical/epidemiological methods -- Navigating research methods: qualitative methods -- Navigating research methods: evidence-based medicine (EBM) -- Navigating research methods: critical appraisal -- Navigating research methods: clinical audit -- Setting the scene and ICH GCP in clinical and healthcare research -- Informed consent in a research setting -- Ethics of clinical and healthcare research: general considerations, Mental Capacity Act, Human Tissue Act -- Role and responsibilities: investigator and research team -- Role and responsibilities of the sponsor -- Monitoring -- Clinical trial design -- Clinical trial protocols: study protocol -- Data capture tools: case report form (CRF) -- Clinical trial supplies: investigational medicinal products (IMPs) -- IMP accountability -- Safety reporting -- Data management -- Research project management -- Essential documents -- Archiving -- Audits and inspections -- Fraud and misconduct -- Authorship -- Publication process -- Start-up toolkit: from funding an idea, through implementation, to achieving an impact. |
Subject |
Biomedical Research -- methods.
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Research Design.
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Clinical Trials as Topic -- methods.
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Health Services Research.
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Other Number |
2015941607 |
Alt Author |
Ray, Sumantra (Shumone), editor.
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Fitzpatrick, Sue, editor.
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Golubic, Rajna, editor.
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Fisher, Susan, editor.
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ISBN |
9780199608478 (flexicover) |
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