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|English to Russian translations [PRO]|
Medical - Medical: Pharmaceuticals / clinical trial
|English term or phrase: field based setting|
|Наблюдательное постмаркетинговое исследование. |
Aim of this study was to collect safety and efficacy data of the marketed product [drug name] - in a ***field based setting***.
То есть это больные принимали препарат, но не в стенах центра.
Сбор данных в негоспитализированной популяции?
Selected response from:
Local time: 21:08
4 KudoZ points were awarded for this answer
21 mins confidence: 23 mins confidence:
у амбулаторных пациентов
у амбулаторных пациентов
Note added at 53 mins (2007-11-05 14:57:04 GMT)
Вариант - у пациентов, проходящих лечение на дому
А еще см
В данной ссылке указывается, что больные лечатся на дому.
Design and implementation issues for randomized controlled trials in field-based developing country settings
The fourth step consists of the double-blind randomization procedure, a process whereby allocation must be unknown to subjects, investigators and outcome assessors (i.e., double-blinding), and any subject being enrolled has an equal probability of being allocated to any group (i.e., randomization) (16, 17). Use of double-blinding avoids bias to unintended interventions and ascertainment bias, whereas use of randomization ensures that bias is prevented and that the groups at baseline are comparable with respect to both measured and immeasurable variables. For successful double-blinding, an independent person/group must be responsible for drawing the randomization code and then a two-stage process must be used for labeling the allocation of the treatment, first at the group, and then at the subject level. In addition, the color, taste and packaging of all treatments must be prepared so that they are identical, and the frequency and dose of treatments must be considered carefully. For successful randomization, simple or permuted block randomization (fixed or variable block length) is required using random number tables or appropriate computer software. Details of this process must be fully documented (15). At this stage, certain delivery issues related to the intervention must also be considered, such as ***storage of the treatments in the field, their packaging, transfer and labeling, quantity of supply to be left in the """home"""***, frequency of delivery, monitoring of compliance, and concerns about "contamination" and sharing among family members. For large trials, initial and ongoing consultation with a data safety and monitoring body (DSMB) is recommended. The purpose of the DSMB is to interact with the Human Ethics Committee to establish the frequency and variables to be reviewed, to determine the sample size and the early stopping rules for safety and/or efficacy and to review data from other studies (14).
| Marina Mrouga|
Local time: 20:08
Specializes in field
Native speaker of: Russian
PRO pts in category: 270
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