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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 ]
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.
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).
In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases.
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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If the template has a separate documentation page (usually called "Template:template name/doc"), add [[Category:Medicine procedure templates]] to the <includeonly> section at the bottom of that page. Otherwise, add <noinclude>[[Category:Medicine procedure templates]]</noinclude>