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The TIG is a stand-alone, implementation guide and is not intended to be inherently related to or dependent on other implementation guides published by CDISC. However, to ensure support alignment across implementations implementation approaches and for efficiency, the TIG was developed in part by leveraging content published in the CDISC implementation guides listed below. Given this, implementers familiar with these guides may recognize  recognize alignment and content shared with these guides.

  • 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.
  • 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 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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