Mandatory literature

• 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/Compulsory*
• 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.pdfCompulsory*
• ICH Topic E6: Guideline for Good Clinical Practice, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdfCompulsory*
• ICH Topic E8: General Considerations for Clinical Trials, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002877.pdfCompulsory*
• 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.pdfCompulsory*
• ICH topic E9: Statistical Principles for Clinical Trials, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002928.pdfCompulsory*
• 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.pdfCompulsory*
• Pharmacokinetics studies in man, European Medicines Agency, 1988, https://www.ema.europa.eu/documents/scientific-guideline/pharmacokinetic-studies-man_en.pdfCompulsory*
• 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.pdfCompulsory*
• 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.pdfCompulsory*

Recommended literature

• 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
• 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
• CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials, BMJ, 2010, Artikel med checklista, förklaringar och bakgrund (open access)
• Pocock, Stuart J., Clinical trials: a practical approach, Chichester, Wiley, cop. 1983
• Friedman, Lawrence M. et al., 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
• 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

* Compulsory