federal_register: 2014-27384

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2014-27384 Electronic Study Data Submission; Data Standards; Validation Rules for Study Data Tabulation Model Formatted Studies; Availability Notice The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is announcing the availability of a document entitled "Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies." CDER is making this document available to improve the standardization and quality of clinical data submitted to CDER, as well as to improve the predictability of data quality and usefulness. 2014-11-19 2014 11 https://www.federalregister.gov/documents/2014/11/19/2014-27384/electronic-study-data-submission-data-standards-validation-rules-for-study-data-tabulation-model https://www.govinfo.gov/content/pkg/FR-2014-11-19/pdf/2014-27384.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is announcing the availability of a document entitled "Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies." CDER is making this document...

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