Translation glossary: Clinical Trials

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.

HIPAA

Закон США о сохранении медицинского страхования и персонифицированном учете в здравоохранении

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intention-to-treat, intent-to-treat

Выборочная совокупность «пациенты, начавшие получать лечение» (Intent-to-Treat, ITT)

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investigational drug

экспериментальное лекарственное средство или (кратко) экспериментальный препарат

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last-observation-carried-forward method

метод переноса данных последнего наблюдения (LOCF)

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MedDRA / Medical Dictionary for Regulatory Activities

Медичний словник термінів регламентуючої діяльності

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MedDRA / Medical Dictionary for Regulatory Activities

Медицинский словарь терминов регламентирующей деятельности

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medical emergency

неотложное состояние

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microsomal mutagenicity assay

анализ микросомальной мутагенности

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Notice of Privacy Practices

«Уведомление о мерах по соблюдению врачебной тайны и конфиденциальности личной информации»

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Notice of Privacy Practices

Уведомление о мерах по соблюдению врачебной тайны и неприкосновенности частной жизни

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NOTICE OF PRIVACY PRACTICES ACKNOWLEDGMENT

ПОДТВЕРЖДЕНИЕ ПОЛУЧЕНИЯ УВЕДОМЛЕНИЯ О МЕРАХ ПО СОБЛЮДЕНИЮ ВРАЧЕБНОЙ ТАЙНЫ И КОНФИДЕНЦИАЛЬНОСТИ ЛИЧНОЙ ИНФОРМАЦИИ

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Per-Protocol

Выборочная совокупность «пациенты, выполнившие требования протокола» (Per-Protocol, PP)

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Primary endpoint / secondary endpoint

Главный / второстепенный конечный показатель

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reconstitution

добавление растворителя

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reflex

Анализ мочи с посевом и микроскопией культуры после выявления отклонений от нормы в первичном анализе

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Urinalysis reflex, or urinalysis with reflex, is follow-up testing to further explore abnormal results found in a routine dipstick test. It involves culturing the urine to determine with greater specificity the type of bacteria present.

Standard Urinalysis
Urinalysis is the chemical, microscopic and physical examination of a urine sample taken from a patient. It can reveal much about the compounds that pass through the urine, and can help to diagnose a wide range of illnesses.

Areas of Evaluation
In standard urinalysis, the sample is observed for color and clarity, and tested for the presence of things such as nitrites, excessive proteins and bacteria, which may indicate infection.

Reflex Testing
If abnormal levels of certain nitrites, leukocytes, blood or proteins are found in the standard urinalysis, a urinalysis reflex automatically calls for the further culturing of the urine sample to gather more information about the type of bacteria present, without a separate order being submitted.

Urine Culture & Sensitivity
Urine culture and sensitivity is the second step in a urinalysis with reflex. This further testing allows a sample of the urine to be microscopically observed over 24 to 48 hours to assess the growth of present bacteria or yeast. By gathering this information, your physician can make a more definite diagnosis of a urinary tract infection.

Reflex Testing Helps with Treatment
Another advantage to the culture that is performed in a urinalysis with reflex is that it helps your physician determine the best course of treatment for a UTI. By prescribing a medication known to be effective in wiping out the specific bacteria found in your urine, he is better able to eradicate the infection.

Reflex Testing

Контрольный анализ при выявлении отклонений от нормы в первичном анализе

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