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field based setting

Russian translation: в реальных условия применения

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:field based setting
Russian translation:в реальных условия применения
Entered by: Ksenia ILINSKA
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14:03 Nov 5, 2007
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?
Ksenia ILINSKA
Ukraine
Local time: 18:55
в реальных условия применения
Explanation:
Т.е. не в исследовании.
Selected response from:

Pavel Venediktov
Russian Federation
Local time: 18:55
Grading comment
Спасибо!
4 KudoZ points were awarded for this answer

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Summary of answers provided
4в реальных условия применения
Pavel Venediktov
4у амбулаторных пациентов
Marina Mrouga
3по различным областям применения
Pavel Nikonorkin
3в (других) центрах клиничского исследованияLeila Usmanova


Discussion entries: 1





  

Answers


21 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
по различным областям применения


Explanation:
Целью этого исследования был сбор данных по безопасности и эффективности коммерческого продукта по различным областям применения.

Pavel Nikonorkin
Local time: 18:55
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 1339
Login to enter a peer comment (or grade)

23 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
у амбулаторных пациентов


Explanation:
у амбулаторных пациентов

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Note added at 53 mins (2007-11-05 14:57:04 GMT)
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Вариант - у пациентов, проходящих лечение на дому


А еще см
http://www.proz.com/kudoz/1788714
http://www.proz.com/?sp=h&id=486268&keyword=field
http://www.proz.com/kudoz/504334

В данной ссылке указывается, что больные лечатся на дому.

http://jn.nutrition.org/cgi/content/full/133/5/1569S
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: 18:55
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 270
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59 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
в (других) центрах клиничского исследования


Explanation:
http://www.tiptopjob.com/search/jobs/2062454_job.asp
We are currently looking for a Field Based Clinical Research Associate to join a leading Clinical Research Organisation in the North East.

Individuals within this role will perform routine clinical trial site visits to ensure that the rights and well-being of human subjects are protected; the reported trial data are accurate, complete, and verifiable from source documents; and that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), SOPs, GCP/ICH
... The Position requires approximately 60% travel (up to 80% during peak times).


Leila Usmanova
Local time: 18:55
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 2493
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1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
в реальных условия применения


Explanation:
Т.е. не в исследовании.

Pavel Venediktov
Russian Federation
Local time: 18:55
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 1149
Grading comment
Спасибо!

Peer comments on this answer (and responses from the answerer)
neutral  Marina Mrouga: Павел, но оно же в исследовании! Прост исследование неслепое, нерандомизированное и прочие "не"
52 mins
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