CLINICAL TRIALS - 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*
• European Medicines Agency, ICH E2A: Clinical safety data management: definitions and standards for expedited reporting, EMA, 1995, ICH E2ACompulsory*
• European Medicines Agency, ICH Topic E3: Structure and Content och Clinical Study Reports, EMA, https://www.ema.europa.eu/en/ich-e3-structure-content-clinical-study-reports-scientific-guidelineCompulsory*
• European Medicines Agency, ICH Topic E4: Dose-Response Information to Support Drug Registration, EMA, https://www.ema.europa.eu/en/ich-e4-dose-response-information-support-drug-registration-scientific-guidelineCompulsory*
• European Medicines Agency, ICH Topic E6: Guideline for Good Clinical Practice, EMA, https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice-scientific-guidelineCompulsory*
• European Medicines Agency, ICH Topic E8: General Considerations for Clinical Studies, EMA, https://www.ema.europa.eu/en/ich-e8-general-considerations-clinical-studies-scientific-guidelineCompulsory*
• European Medicines Agency, ICH topic E9: Statistical Principles for Clinical Trials, EMA, https://www.ema.europa.eu/en/ich-e9-statistical-principles-clinical-trials-scientific-guidelineCompulsory*
• European Medicines Agency, ICH topic E10: Choice of Control Group in Clinical Trials, EMA, https://www.ema.europa.eu/en/ich-e10-choice-control-group-clinical-trials-scientific-guidelineCompulsory*
• 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, http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1497947926249&uri=CELEX:32014R0536Compulsory*
• The CONSORT Group, Consort Checklist, The CONSORT Group, 2025, Consort homepageCompulsory*

* Compulsory