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...
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A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. The case report form is the tool used...
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Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical...
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Clinical study design is the formulation of clinical trials and other experiments, as well as observational studies, in medical research involving human...
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Preregistration (science) (redirect from Clinical trial registration)
scientific study before it is conducted. Clinical trial registration is similar, although it may not require the registration of a study's analysis protocol...
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Randomized controlled trial (redirect from Randomized clinical trial)
"Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov". Health Affairs. 30 (12): 2338–2345...
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1988 study on clinical lycanthropy from the McLean Hospital reported on a series of cases, and proposed some diagnostic criteria by which clinical lycanthropy...
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extenders reported experiencing bruising, temporary discoloration, pain and itching. "Penile Extender Increased Flaccid Length By Almost A Third, Clinical Study...
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process that changes the constant region of an immunoglobulin Clinical study report, on a clinical trial Combat stress reaction, a condition also known as shell...
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case reports also contain a literature review of other reported cases. Case reports are professional narratives that provide feedback on clinical practice...
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Blinded experiment (redirect from Double-blind study)
information becomes available to one from whom it has been masked. In clinical studies, unblinding may occur unintentionally when a patient deduces their...
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For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially...
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Duloxetine (section Postmarketing reports)
(ISMP) published a report: "Duloxetine and Serious Withdrawal Symptoms".[citation needed] The report highlights early clinical studies which found "abrupt...
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A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered...
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on full clinical study reports and regulatory documents. In 2016, Roche's oseltamivir patents began to expire. There have been[when?] reports of oseltamivir...
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number of people enrolled who reached the pre-determined clinical endpoint during the study interval compared with the overall number of people who were...
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Adverse effect (category Clinical pharmacology)
clinical trials are obligated to report these events in clinical study reports. Research suggests that these events are often inadequately reported in...
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mild and sub-clinical to severe and highly disabling. The reported prevalence of clinically significant misophonia varies widely across studies due to the...
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for stroke and systemic embolic events. A 5-year follow-up study study". Clinical Study Report Synopsis. AstraZeneca. 21 January 2010. Trial D1250C0004221...
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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (redirect from Harmonization in clinical trials)
Therapeutic Products Authority Biotechnology Innovation Organization Clinical study report Clinical trial Common Technical Document Council for International Organizations...
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A clinical trial portal (also known as clinical portal or clinical study portal) is a web portal or enterprise portal that primarily serves sponsors and...
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List of Guidances for Statistics in Regulatory Affairs (category Clinical trials)
relevant to regulatory affairs for those statisticians that work on clinical studies. The List is associated with the Wikipedia page Guidances for statistics...
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Cass Review (redirect from Cass Report)
blockers be paused until clinical trials are begun. NHS Scotland will participate in the forthcoming UK study. That report was fully accepted by the...
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Medical writing (category Clinical research)
documents can be huge and are formulaic. They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures...
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involved in the clinical trial is qualified by training, education and experience. Informed consent is given freely by every participant. All study documentation...
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"Strengthening the Reporting of Observational Studies in Epidemiology for respondent-driven sampling studies: "STROBE-RDS" statement". Journal of Clinical Epidemiology...
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form Failure to report adverse events Failure to account for the disposition of study drugs Therefore, the primary goal of clinical trial monitoring...
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industries to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant...
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publications concerning clinical vampirism can be found in the literature of forensic psychiatry, with the behavior being reported as an aspect of extraordinary...
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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...
79 KB (11,627 words) - 20:58, 29 May 2025