Glossary entry (derived from question below)
Jun 28, 2022 03:59
1 yr ago
20 viewers *
English term
Medical translation by medical doctor
Native in: Russian 
, Ukrainian
Works in: English to Russian
casebook
English to Russian
Medical
Medical (general)
клинические исследования
The Investigator will then electronically sign the casebook, specifying that the information
on the CRFs is accurate and complete. The Data Manager, or designee, will then set the
status of the forms, visits, and the entire casebook to Locked. Upon completion of the CSR,
an electronic copy of each site’s casebooks will be copied to a compact disk (CD) and sent to
each site for retention with other study documents.
on the CRFs is accurate and complete. The Data Manager, or designee, will then set the
status of the forms, visits, and the entire casebook to Locked. Upon completion of the CSR,
an electronic copy of each site’s casebooks will be copied to a compact disk (CD) and sent to
each site for retention with other study documents.
Proposed translations
(Russian)
| 4 +1 | ИРК |
Vladimir Vaguine
|
| 4 | лабораторный журнал |
Anaida Julhakyan (X)
|
Proposed translations
+1
6 hrs
Vladimir Vaguine
Russian Federation
Russian Federation
Native in Russian
Specializes in field
Russian Federation
Translator since 1982
Native in: Russian
Works in: English to Russian, French to Russian, Russian
Related KudoZ points
:
272
Selected
ИРК
Под CRF может пониматься как весь документ, так и отдельные страницы/разделы этой формы. В последнем случае отдельные страницы собираются в case report book/casebook. Обратите внимание на второй пункт:
case report form
(1) A printed, optical or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each subject/patient in a clinical trial.
(2) A record of clinical study observations and other information that must be completed for each subject in a clinical trial, per study protocol mandate. CRF can refer to either a CRF page (which contains one or more data items linked together for collection and display) or a casebook (which includes all CRF pages on which a set of clinical study observations and other information can be or have been collected, or the information collected by completion of such CRF pages for a subject/patient in a clinical study).
(https://medical-dictionary.thefreedictionary.com/case report...
У нас под ИРК, как правило, понимается единый документ на бумажном, электронном или оптическом носителе, предназначенный для внесения всей предусмотренной протоколом и подлежащей передаче спонсору информации по каждому субъекту исследования, и состоящий из отдельных разделов/страниц.
В вашем случае фразу "The Investigator will then electronically sign the casebook, specifying that the information on the CRFs is accurate and complete." я бы перевел так:
Исследователь подписывает ИРК в электронной форме, указав, что информация, содержащаяся в ней, является точной и полной.
case report form
(1) A printed, optical or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each subject/patient in a clinical trial.
(2) A record of clinical study observations and other information that must be completed for each subject in a clinical trial, per study protocol mandate. CRF can refer to either a CRF page (which contains one or more data items linked together for collection and display) or a casebook (which includes all CRF pages on which a set of clinical study observations and other information can be or have been collected, or the information collected by completion of such CRF pages for a subject/patient in a clinical study).
(https://medical-dictionary.thefreedictionary.com/case report...
У нас под ИРК, как правило, понимается единый документ на бумажном, электронном или оптическом носителе, предназначенный для внесения всей предусмотренной протоколом и подлежащей передаче спонсору информации по каждому субъекту исследования, и состоящий из отдельных разделов/страниц.
В вашем случае фразу "The Investigator will then electronically sign the casebook, specifying that the information on the CRFs is accurate and complete." я бы перевел так:
Исследователь подписывает ИРК в электронной форме, указав, что информация, содержащаяся в ней, является точной и полной.
4 KudoZ points awarded for this answer.
Comment: "Спасибо, Владимир!
Кто бы мог подумать, что это ИРК )"
3 hrs
лабораторный журнал
Лабораторный журнал, журнал лабораторных исследований.Иногда "история болезни", но, кажется, здесь не тот случай.
У Апресяна это "лабораторный журнал", "журнал для записи пациентов", "журнал с историями болезней" и т. п.
https://slovaronline.com/browse/df8c855a-e3ff-3314-908f-c48b...
Если речь идет о каких-то конкретных исследованиях, то по ссылке "Формы медицинской документации".
https://base.garant.ru/52490030/#friends
У Апресяна это "лабораторный журнал", "журнал для записи пациентов", "журнал с историями болезней" и т. п.
https://slovaronline.com/browse/df8c855a-e3ff-3314-908f-c48b...
Если речь идет о каких-то конкретных исследованиях, то по ссылке "Формы медицинской документации".
https://base.garant.ru/52490030/#friends
Reference:
https://base.garant.ru/52490030/#friendshttp://
https://slovaronline.com/browse/df8c855a-e3ff-3314-908f-c48b9705812f/casebookhttp://
Reference comments
2 hrs
Reference:
What is the meaning of casebook?
Definition of casebook
1 : a book containing records of illustrative cases that is used for reference and instruction (as in law or medicine) - https://www.merriam-webster.com/dictionary/casebook
Definition of casebook
1 : a book containing records of illustrative cases that is used for reference and instruction (as in law or medicine) - https://www.merriam-webster.com/dictionary/casebook
Discussion
A CRA designated by Company will compare the CRFs with the original source documents
at the study site and evaluate them for completeness and accuracy before designating them as “Source Data Verified” (SDV). If an error is discovered at any time or a clarification is needed, the CRA, or designee, will create an electronic query on the associated field. Site
personnel will then answer the query by either correcting the data or responding to the query. The CRA will then review the response and determine either to close the query or re–query the site if the response does not fully address the question. This process is repeated until all open queries have been answered and closed.
The Investigator will then electronically sign the casebook, specifying that the information
on the CRFs is accurate and complete. The Data Manager, or designee, will then set the
status of the forms, visits, and the entire casebook to Locked. Upon completion of the CSR, an electronic copy of each site’s casebooks will be copied to a compact disk (CD) and sent to each site...