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Pharmacy 2015 AD09SDTM Annotations: Automation by implementing a standard process Geo Joy, Novartis, Cambridge, MA Andre Couturier, Novartis, East Hanover, NJ ABSTRACT Annotating a Blank Case Report
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What is sdtm annotations automation by?
SDTM annotations automation is done by utilizing software tools to generate SDTM annotations automatically.
Who is required to file sdtm annotations automation by?
Sponsor companies and organizations conducting clinical trials are required to file SDTM annotations automation.
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SDTM annotations automation can be filled out by using specialized software that maps the data to SDTM standards.
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The purpose of SDTM annotations automation is to ensure that clinical trial data is standardized and compliant with regulatory requirements.
What information must be reported on sdtm annotations automation by?
SDTM annotations automation must report detailed information about the datasets used in the clinical trial and how they are mapped to SDTM standards.
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