Page History

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• Version 3.1.1 of the Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) for nonclinical studies, (available at https://www.cdisc.org/standards/foundational/send/sendig-v3-1-1), intended to guide the organization, structure, and format of standard nonclinical tabulation datasets for interchange between organizations such as sponsors and contract research organizations (CROs), and for submission to regulatory authorities.
• Add CDASHVersion 2.2 of the Clinical Data Acquisition Standards Harmonization Implementation Guide (CDASHIG), (available at https://www.cdisc.org/standards/foundational/cdash/cdashig-v2-2), which defines basic standards for the collection of clinical trial data and how to implement the standard for specific case report forms (CRFs).
• Version 3.4 of the Study Data Tabulation Model Implementation Guide (SDTMIG): Human Clinical Trials, (available at https://www.cdisc.org/standards/foundational/sdtmig/sdtmig-v3-4), intended to guide the organization, structure, and format of standard clinical trial tabulation datasets may be used for various purposes, including publication, warehousing, meta-analyses, and regulatory submission.                           
• Version 1.3 of the of the Analysis Data Model Implementation Guide (ADaMIG), (available at https://www.cdisc.org/standards/foundational/adam/adamig-v1-3) which specifies ADaM standard dataset structures and variables, including naming conventions. 

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