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[from ICH E9] The term masking is often preferred to blinding in the field of ophthalmology. 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. 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. A record of clinical study observations and other information that a study protocol designates must be completed for each subject.
The case history for each individual shall document that informed consent was obtained prior to participation in the study. 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 and other information can be or have been collected, or the information actually collected by completion of such CRF pages for a subject in a clinical study [ICH E6 Glossary]. Data evaluated by sorting values (for example, severe, moderate, and mild) into various categories. An evaluation performed by a medical professional concerning the likelihood that a therapy or product under study caused or contributed to an adverse event. 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.
The study groups should be compared at baseline for important demographic and clinical characteristics.
Baseline data may be especially valuable when the outcome measure can also be measured at the start of the trial. Systematic error in creating intervention groups, such that they differ with respect to prognosis.
NOTE: Standardizing analysis datasets is intended to make review and assessment of analysis more consistent [ADa M]. A set of subjects whose data are to be included in the main analyses.
This should be defined in the statistical section of the protocol.
NOTE: FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, "whether or not considered to be drug-related." CDISC recognizes that current usage incorporates the concept of causality.