Full Analysis Set (FAS) полное множество для анализа
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| Language pair: | English to Russian |
| Definition / notes: | Presented below are some of the relevant information found in ICH Guideline E9: GLOSSARY Intention-To-Treat Principle The principle that asserts that the effect of a treatment policy can be best assessed by evaluating on the basis of the intention to treat a subject (i.e. the planned treatment regimen) rather than the actual treatment given. It has the consequence that subjects allocated to a treatment group should be followed up, assessed and analysed as members of that group irrespective of their compliance to the planned course of treatment. Full Analysis Set The set of subjects that is as close as possible to the ideal implied by the intention-to-treat principle. It is derived from the set of all randomised subjects by minimal and justified elimination of subjects. Per Protocol Set (Valid Cases, Efficacy Sample, Evaluable Subjects Sample) The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol violations. 5.2 Analysis Sets The set of subjects whose data are to be included in the main analyses should be defined in the statistical section of the protocol. In addition, documentation for all subjects for whom trial procedures (e.g. run-in period) were initiated may be useful. The content of this subject documentation depends on detailed features of the particular trial, but at least demographic and baseline data on disease status should be collected whenever possible. If all subjects randomised into a clinical trial satisfied all entry criteria, followed all trial procedures perfectly with no losses to follow-up, and provided complete data records, then the set of subjects to be included in the analysis would be self-evident. |
| URL: | http://www.cdisc.org/bbs/forums/thread-view.asp?tid=2095&DisplayType=threaded&setCookie=1 |
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