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Exploring CDISC Analysis Data Model (ADaM) Datasets

Clinical Programming Team

Clinical Data Interchange Standards Consortium (CDISC) defines and manages industry level data standards that are widely used during the analysis, reporting and submission of clinical data. For instance, the Study Data Tabulation Model (SDTM) is the submission data standard into which raw study data are mapped and collated. ADaM is a companion standard for use with analysis data and it is best practice to use SDTM data as the source for these datasets. Doing this allows for the easy documentation of any data processing with Define-XML, the CDISC standard for data definition files.

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Topics: Traceability, CDISC SDTM, CDISC, Standardization, Adverse Events (AEs), Clinical Trial Documentation, Clinical Programming, SDTM, CDISC Standards, ADaM Datasets, Analysis Data Model, ADSL

How to Find Traceability Solutions For Your Outsourced Clinical Data

Michael Whitworth

The regulatory importance of knowing where your data are, reproducibility of results.  SI 2004/1031: Schedule 1, Part 2,10: “All clinical trial information shall be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.”

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), CRO Selection, Clinical Data Storage, Traceability

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