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The terms clinical trial and clinical study are synonymous. (ICH E6) Clinical Trial/Study Report A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. (ICH E6)
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Clinical trials publication; Clinical trials unit; Cluster-randomised controlled trial; Code-break procedure; Cohen's h; Common Technical Document; Common Terminology Criteria for Adverse Events; Community advisory board; Community-based clinical trial; Consecutive case series; Consecutive controlled case series; Contract research organization ...
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.
Clinical trial – an experiment with human subjects to assess safety and efficacy of drugs Academic clinical trials – clinical trials run at academic centers (e.g., medical schools, academic hospitals, and universities) Clinical trials unit – biomedical research units dedicated to conducting clinical trials
The IB is a document of critical importance throughout the drug development process and is updated with new information as it becomes available. The purpose of the IB is to compile data relevant to studies of the IP in human subjects gathered during preclinical and other clinical trials.
The Systematized Nomenclature of Medicine (SNOMED) is a systematic, computer-processable collection of medical terms, in human and veterinary medicine, to provide codes, terms, synonyms and definitions which cover anatomy, diseases, findings, procedures, microorganisms, substances, etc. It allows a consistent way to index, store, retrieve, and ...
In medicine, a clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-reviewed academic paper. [ 1 ]