3FB030 · 7,5 hp · Avancerad nivå

Klinisk prövningsmetodik

Litteraturlista giltig från hösten 2019

Hämtad från uu.se 14 okt. 2026 · Visa originalet på uu.se

Den senaste listan är från hösten 2019 och kan vara inaktuell. Kontrollera med kursen innan du köper.

Obligatorisk litteratur

Obligatorisk litteratur

  • WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, World Medical Association, https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/

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    WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, World Medical Association, https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/

  • Guideline for good clinical practice E6 (R1), International conference on harmonization of technical requirements for registration of pharmaceuticals for human use, 1996, https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf

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    Guideline for good clinical practice E6 (R1), International conference on harmonization of technical requirements for registration of pharmaceuticals for human use, 1996, https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf

  • ICH Topic E6: Guideline for Good Clinical Practice, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf

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    ICH Topic E6: Guideline for Good Clinical Practice, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf

  • ICH Topic E8: General Considerations for Clinical Trials, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002877.pdf

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    ICH Topic E8: General Considerations for Clinical Trials, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002877.pdf

  • ICH Topic E3: Structure and Content och Clinical Study Reports, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002832.pdf

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    ICH Topic E3: Structure and Content och Clinical Study Reports, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002832.pdf

  • ICH topic E9: Statistical Principles for Clinical Trials, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002928.pdf

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    ICH topic E9: Statistical Principles for Clinical Trials, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002928.pdf

  • ICH topic E10: Choice of Control Group and Related Issues in Clinical Trials, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002925.pdf

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    ICH topic E10: Choice of Control Group and Related Issues in Clinical Trials, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002925.pdf

  • Pharmacokinetics studies in man, European Medicines Agency, 1988, https://www.ema.europa.eu/documents/scientific-guideline/pharmacokinetic-studies-man_en.pdf

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    Pharmacokinetics studies in man, European Medicines Agency, 1988, https://www.ema.europa.eu/documents/scientific-guideline/pharmacokinetic-studies-man_en.pdf

  • ICH Topic E4: Dose-Response Information to Support Drug Registration, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002834.pdf

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    ICH Topic E4: Dose-Response Information to Support Drug Registration, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002834.pdf

  • CPMP/EWP/908/99: POINTS TO CONSIDER ON MULTIPLICITY ISSUES IN CLINICAL TRIALS, EMA, European Medicines Agency, http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003640.pdf

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    CPMP/EWP/908/99: POINTS TO CONSIDER ON MULTIPLICITY ISSUES IN CLINICAL TRIALS, EMA, European Medicines Agency, http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003640.pdf

Övrig litteratur (inte markerad som obligatorisk)

Obligatorisk litteratur › Rekommenderad litteratur

  • REGULATION No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, repealing Directive 2001/20/EC., EU, länk

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    REGULATION No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, repealing Directive 2001/20/EC., EU, länk

  • DIRECTIVE 2001/20/E, laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, EU, https://ec.europa.eu/health/human-use/clinical-trials/directive_en

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    DIRECTIVE 2001/20/E, laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, EU, https://ec.europa.eu/health/human-use/clinical-trials/directive_en

  • 2011/C 172/01: Communication from the Commission - Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (CT-3), EU, http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1497948126522&uri=CELEX:52011XC0611(01)

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    2011/C 172/01: Communication from the Commission - Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (CT-3), EU, http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1497948126522&uri=CELEX:52011XC0611(01)

  • Consort 2010 Checklist, Explanations and Elaboration document, The CONSORT Group, 2010, CONSORT hemsida

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    Consort 2010 Checklist, Explanations and Elaboration document, The CONSORT Group, 2010, CONSORT hemsida

  • CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials, BMJ, 2010, Artikel med checklista, förklaringar och bakgrund

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    open access

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    CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials, BMJ, 2010, Artikel med checklista, förklaringar och bakgrund (open access)

  • Clinical trials: a practical approach

    Verifierad upplaga

    Pocock, Stuart J. · 1983

    ISBN 9780471901556 · tryckt

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    Pocock, Stuart J., Clinical trials: a practical approach, Chichester, Wiley, cop. 1983

  • Fundamentals of Clinical Trials

    Verifierad upplaga

    Friedman, Lawrence M. m.fl. · 5th ed. 2015. · Springer International Publishing · 2015

    ISBN 9783319185392 · e-bok

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    Friedman, Lawrence M. m.fl., Fundamentals of Clinical Trials, 5th ed. 2015., Cham, Springer International Publishing, 2015

  • EMA/CPMP/EWP/1776/99 Rev. 1: Guideline on Missing Data in Confirmatory Clinical Trials, EMA, European Medicines Agency, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500096793.pdf

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    EMA/CPMP/EWP/1776/99 Rev. 1: Guideline on Missing Data in Confirmatory Clinical Trials, EMA, European Medicines Agency, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500096793.pdf

  • CPMP/EWP/482/99: POINTS TO CONSIDER ON SWITCHING BETWEEN SUPERIORITY AND NON-INFERIORITY, EMA, European Medicines Agency, http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003658.pdf

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    CPMP/EWP/482/99: POINTS TO CONSIDER ON SWITCHING BETWEEN SUPERIORITY AND NON-INFERIORITY, EMA, European Medicines Agency, http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003658.pdf

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