Glossary
TRREE Glossary
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Non-interventional trialEssai non-interventionnel -- Nicht-interventionelle Prüfung A study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the 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, art. 2c |
Non-maleficenceNon-malfaisance -- Primum nil nocere-Prinzip, Schadensvermeidung 1) This principle proscribes the deliberate infliction of harm on persons
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, General ethical principles 2) literally, not doing wrong. Physicians and medical researchers are to avoid inflicting harm on patients and research subjects.
World Medical Association, Medical Ethics Manual, Ferney-Voltaire, WMA, 2nd ed., 2009, Appendix A, Glossary |
Non-therapeutic proceduresInterventions non thérapeutiques -- Nichttherapeutische Massnahmen Actions that go beyond the needs of the patient- participant, and that are incurred only for the needs of the research.
Québec health and social services network, Tutorial in research ethics, Resources – Glossary |
Nonclinical StudyÉtude non clinique -- Präklinische Prüfung Biomedical studies not performed on human subjects.International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.41 |