Common CDISC Compliance Findings for Regulatory Submission

Addressing Common CDISC Compliance Findings for Regulatory Submission

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The Clinical Data Interchange Standards Consortium (CDISC) recommends, and most regulatory authorities require, the use of the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards for submission of clinical study data. Since CDISC made the recommendation in 2004, pharmaceutical and biotechnology companies have been focused on complying with these standards, while also…