interventional agent

Russian translation: препарат интервенционной терапии или препарат, применяемый в интервенционном исследовании

11:09 Feb 6, 2018
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals / Clinical trials
English term or phrase: interventional agent
Of these, 2 subjects participated in a trial with an interventional agent (see Section 10.4.4.8 for details)
Julia Berezina
Local time: 10:35
Russian translation:препарат интервенционной терапии или препарат, применяемый в интервенционном исследовании
Explanation:
interventional agent = препарат интервенционной терапии или препарат, который применяется в интервенционном исследовании
trial with an interventional agent = интервенционное исследование или исследование интервенционной терапии

интервенционная терапия = терапия, которая не соответствует принятой/одобренной клинической практике


Of these, 2 subjects participated in a (see Section 10.4.4.8 for details).
Из них 2 субъекта участвовали в интервенционном исследовании/участвовали в исследовании препарата интервенционной терапии.

http://www.appliedclinicaltrialsonline.com/interventional-vs...
In order to be classified as an interventional clinical trial, a study must first meet any of the following three criteria:
1. Assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice (i.e., the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder) of the member state concerned.
2. The decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study.
3. Diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.

The low-intervention clinical trial, on the other hand, must meet all of the following three criteria:
1. The investigational medicinal products, excluding placebos, are authorized.
2. According to the trial protocol, the investigational medicinal products are used in accordance with the terms of the marketing authorization or the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned.
3. The additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any member state concerned.

http://www.chcuk.co.uk/non-interventional-studies/nis-defini...
Non-Interventional Study or Non-Interventional Trial is a study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data (as per Article 2(c) of 2001/20/EC ).
Selected response from:

Margarita Vidkovskaia
Russian Federation
Local time: 10:35
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2препарат интервенционной терапии или препарат, применяемый в интервенционном исследовании
Margarita Vidkovskaia


Discussion entries: 4





  

Answers


2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
препарат интервенционной терапии или препарат, применяемый в интервенционном исследовании


Explanation:
interventional agent = препарат интервенционной терапии или препарат, который применяется в интервенционном исследовании
trial with an interventional agent = интервенционное исследование или исследование интервенционной терапии

интервенционная терапия = терапия, которая не соответствует принятой/одобренной клинической практике


Of these, 2 subjects participated in a (see Section 10.4.4.8 for details).
Из них 2 субъекта участвовали в интервенционном исследовании/участвовали в исследовании препарата интервенционной терапии.

http://www.appliedclinicaltrialsonline.com/interventional-vs...
In order to be classified as an interventional clinical trial, a study must first meet any of the following three criteria:
1. Assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice (i.e., the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder) of the member state concerned.
2. The decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study.
3. Diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.

The low-intervention clinical trial, on the other hand, must meet all of the following three criteria:
1. The investigational medicinal products, excluding placebos, are authorized.
2. According to the trial protocol, the investigational medicinal products are used in accordance with the terms of the marketing authorization or the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned.
3. The additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any member state concerned.

http://www.chcuk.co.uk/non-interventional-studies/nis-defini...
Non-Interventional Study or Non-Interventional Trial is a study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data (as per Article 2(c) of 2001/20/EC ).

Margarita Vidkovskaia
Russian Federation
Local time: 10:35
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 757

Peer comments on this answer (and responses from the answerer)
agree  Elena Evdokimova
22 mins
  -> Спасибо!

agree  svetlana cosquéric
4 hrs
  -> Спасибо!
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