non-interventional clinical study
- Guideline or reference source
- ICHE2F Development safety update report
- Definition
- 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 are applied to the patients and epidemiological methods are used for the analysis of collected data
- Used For
- observational study
- Broader Term
- clinical trial design
- Related Term
- post-authorisation safety study
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