Glossaries
Glossaries
| Term | Definition |
|---|---|
| CDISC Library |
A global, accessible, electronic library, which, through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare. NOTE: Formerly known as CDISC SHARE. [CDISC]
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| CDISC Glossary |
The terminology of the Clinical Data Interchange Standards Consortium (CDISC) glossary.
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CDISC Glossary |
| causality assessment |
An evaluation performed by a medical professional concerning the likelihood that a therapy or product under study caused or contributed to an adverse event.
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| categorical data |
Data evaluated by sorting values (for example, severe, moderate, and mild) into various categories.
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| case-control study |
Retrospective study in which individuals with an outcome (cases) are compared with those who do not have the outcome (controls). The outcome variable (disease, event, experience, biomarker) is chosen first, and the exposure (e.g., treatment) is evaluated in cases vs controls to see whether there is an association between exposure and outcome. [After AMA Manual of Style] See also outcome, observational study, exposure.
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| case report tabulations (CRT) |
In a paper submission, listings of data that may be organized by domain (type of data) or by subject. See also eCRT.
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| case report form (CRF) |
A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each trial subject. NOTE: In common usage, CRF can refer to either a CRF page, which denotes a group of one or more data items, linked together for collection and display, or a casebook, which includes the entire group of CRF pages on which a set of clinical study observations can be or have been collected by completion of such CRF pages for a subject in a clinical study. See also CRF (paper), eCRF. [ICH E6 Glossary, FDA Final Guidance on eSource].
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case record form |
| case history |
An adequate and accurate record prepared and maintained by an investigator that records all observations and other data pertinent to the investigation of each individual administered the investigational drug (device or other therapy) or employed as a control in the investigation. NOTE: Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart(s), and the nurses' notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study. [21 CFR 312.62(b)]
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| carry-over effect |
Effects of treatment that persist after treatment has been stopped, sometimes beyond the time of a medication's known biological activity.
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| cache |
Storage area on a computer's hard drive where the browser stores (for a limited time) web pages and/or graphic elements.
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