Oct 31, 2019 12:54
4 yrs ago
English term
remove self-evident corrections language
English to Russian
Medical
Medical: Pharmaceuticals
клинические исследования
- Clarify language for analysis sets and subgroups
- Remove self-evident corrections language
- Update and replace retired pregnancy and lactation notification forms
- Make editorial, typographical, and formatting changes throughout the document
Это поправка к протоколу клин. исследования
- Remove self-evident corrections language
- Update and replace retired pregnancy and lactation notification forms
- Make editorial, typographical, and formatting changes throughout the document
Это поправка к протоколу клин. исследования
Proposed translations
(Russian)
5 +1 | удалена ИНФОРМАЦИЯ об исправлениях, не требующих разъяснений | Natalie |
Proposed translations
+1
2 hrs
Selected
удалена ИНФОРМАЦИЯ об исправлениях, не требующих разъяснений
Из текста протокола удалена ИНФОРМАЦИЯ об исправлениях, не требующих разъяснений, но НИ В КОЕМ СЛУЧАЕ НЕ САМИ исправления!
Во-первых, определение:
Self-evident corrections—Specify the criteria for self-evident corrections
and identify authorized data management personnel who will make these
corrections to the data as necessary. A self-evident correction is a change
to data or resolution of a query that can easily and obviously be made on
the basis of other existing information on the CRF without sending a query
to the investigative site. The most common self-evident corrections are
obvious spelling errors. Self-evident corrections, like all other data
changes, must be clearly documented and audited via the audit trail within
the organization’s database system. A list of approved self-evident
corrections must be included in the DMP or exist in a separate document
to be attached or referenced. Ensure the investigators associated with the
study are in agreement with the self-evident correction process and that
the method of additional documentation (e.g., generation of reports for
sign off) is thoroughly described. Self-evident corrections might not be
applicable to all data management systems and types of data (e.g., source
records).
https://www.mci-registrations.com/be-bruga/mci-registrations...
Обратите внимание на слова "must be clearly documented": понятное дело, что нет необходимости документировать исправление каждой очевидной опечатки. В этой связи из текста протокола убрали информацию о таких изменениях, чтобы не загромождать текст ненужными сведениями.
Во-первых, определение:
Self-evident corrections—Specify the criteria for self-evident corrections
and identify authorized data management personnel who will make these
corrections to the data as necessary. A self-evident correction is a change
to data or resolution of a query that can easily and obviously be made on
the basis of other existing information on the CRF without sending a query
to the investigative site. The most common self-evident corrections are
obvious spelling errors. Self-evident corrections, like all other data
changes, must be clearly documented and audited via the audit trail within
the organization’s database system. A list of approved self-evident
corrections must be included in the DMP or exist in a separate document
to be attached or referenced. Ensure the investigators associated with the
study are in agreement with the self-evident correction process and that
the method of additional documentation (e.g., generation of reports for
sign off) is thoroughly described. Self-evident corrections might not be
applicable to all data management systems and types of data (e.g., source
records).
https://www.mci-registrations.com/be-bruga/mci-registrations...
Обратите внимание на слова "must be clearly documented": понятное дело, что нет необходимости документировать исправление каждой очевидной опечатки. В этой связи из текста протокола убрали информацию о таких изменениях, чтобы не загромождать текст ненужными сведениями.
4 KudoZ points awarded for this answer.
Comment: "Натали, большое спасибо за помощь!"
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