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charter

Spanish translation: documento

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:charter
Spanish translation:documento
Entered by: Alicia Orfalian
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22:13 Nov 18, 2013
English to Spanish translations [PRO]
Medical - Medical: Health Care / Imaging
English term or phrase: charter
...assessments are highly reliant upon the imaging *charter*, image reconstruction and processing parameters...

I can't find the appropriate translation of charter in this context.

Thank you in advance.
Alicia Orfalian
Argentina
Local time: 14:55
documento
Explanation:
Sponsors should generally develop a document that provides a comprehensive, detailed description of the clinical trial imaging methodology if a trial standard for image acquisition and interpretation applies to the imaging data. We suggest sponsors refer to this document as an imaging charter and develop the document with the close vetting typically applied to the main components of a clinical protocol. Indeed, sponsors should generally regard the imaging charter as an integral component of the protocol, much as a statistical analysis plan is often developed as a component of a clinical protocol. The imaging charter can be attached to a clinical protocol as an appendix or developed as a section within the clinical protocol. For FDA review, we encourage submission of the charter simultaneously with a complete clinical protocol, including the final statistical analysis plan and any important supportive documents.
Selected response from:

Marià Pitarque
Spain
Local time: 19:55
Grading comment
Mil gracias por tu ayuda. Saludos, Alicia.
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +3documento
Marià Pitarque


  

Answers


18 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
documento


Explanation:
Sponsors should generally develop a document that provides a comprehensive, detailed description of the clinical trial imaging methodology if a trial standard for image acquisition and interpretation applies to the imaging data. We suggest sponsors refer to this document as an imaging charter and develop the document with the close vetting typically applied to the main components of a clinical protocol. Indeed, sponsors should generally regard the imaging charter as an integral component of the protocol, much as a statistical analysis plan is often developed as a component of a clinical protocol. The imaging charter can be attached to a clinical protocol as an appendix or developed as a section within the clinical protocol. For FDA review, we encourage submission of the charter simultaneously with a complete clinical protocol, including the final statistical analysis plan and any important supportive documents.


    Reference: http://qibawiki.rsna.org/images/0/0e/PIG_March_Meeting_Minut...
    Reference: http://firstclinical.com/regdocs/doc/?showpage=10&db=FDA_Gui...
Marià Pitarque
Spain
Local time: 19:55
Specializes in field
Native speaker of: Native in CatalanCatalan
PRO pts in category: 8
Grading comment
Mil gracias por tu ayuda. Saludos, Alicia.

Peer comments on this answer (and responses from the answerer)
agree  patinba
2 mins
  -> Thanks patinba!

agree  Laura Serván
16 hrs
  -> Gracias Laura

agree  Melina Jaimes
19 hrs
  -> Gracias Melina
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