SDTM, SDRG, ADaM, ADRG, CDISC compliance
SDTM (Standard for Data Tabulation Model is a standardized format for organizing and structuring clinical trial data, making it consistent and understandable for analysis and regulatory submissions.
SDRG (Study Data Reviewer’s Guide)provides detailed guidance on how to create and organize datasets and documentation following the SDTM standards, facilitating the review process for regulatory authorities.
ADaM (Analysis Data Model) is a standardized format for the analysis of datasets in clinical trials. It ensures that data is prepared and structured for statistical analysis, making it easier to derive meaningful insights.
ADRG (Analysis Data Reviewer’s Guide)offers comprehensive instructions for creating and organizing analysis datasets following the ADaM standards. It aids in the review process, making it easier for regulatory authorities to evaluate analysis results.
CDISC Compliance (Clinical Data Interchange Standards Consortium) involves adhering to the standards and guidelines set by CDISC for data collection, management, and submission in clinical trials. It promotes consistency, efficiency, and transparency in clinical research, ensuring that data is structured and standardized for regulatory submissions.
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