3FB030 · 7,5 hp · Avancerad nivå

Klinisk prövningsmetodik

Reading list valid from autumn 2019

Retrieved from uu.se 14 Oct 2026 · View the original on uu.se

The latest list is from autumn 2019 and may be out of date. Check with the course before buying.

Required reading

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/

    Not a book to buy
    As written on the list

    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

    Not a book to buy
    As written on the list

    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

    Not a book to buy
    As written on the list

    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

    Not a book to buy
    As written on the list

    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

    Not a book to buy
    As written on the list

    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

    Not a book to buy
    As written on the list

    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

    Not a book to buy
    As written on the list

    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

    Not a book to buy
    As written on the list

    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

    Not a book to buy
    As written on the list

    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

    Not a book to buy
    As written on the list

    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

Other reading (not marked as required)

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

    Not a book to buy
    As written on the list

    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

    Not a book to buy
    As written on the list

    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)

    Not a book to buy
    As written on the list

    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

    Not a book to buy
    As written on the list

    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

    Not a book to buy

    open access

    As written on the list

    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

    Verified edition

    Pocock, Stuart J. · 1983

    ISBN 9780471901556 · print

    As written on the list

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

  • Fundamentals of Clinical Trials

    Verified edition

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

    ISBN 9783319185392 · e-book

    As written on the list

    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

    Not a book to buy
    As written on the list

    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

    Not a book to buy
    As written on the list

    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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3FB030 Klinisk prövningsmetodik – course literature | LitBook