Cytel Statistician Discusses the Importance of Traceability in R&D Data Handling

Cytel’s Angelo Tinazzi discusses data traceability in a recent blog post. An expert in statistical programming and clinical data analysis, Tinazzi compares traceability as defined by the Food and Drug Administration (FDA) and the Clinical Data Interchange Standards Consortium (CDISC).

According to Tinazzi, “Traceability is crucial in all steps of clinical data handling, from data collection to final analysis. The importance of Traceability in CDISC, and particularly in ADaM [the Analysis Data Model], is continuously “stressed upon” throughout the CDISC documentation (CDISC “ADaM Traceability Examples”; Document will be released in Q4-2021) and at conferences, including a recent FDA presentation at CDISC EU 2021 European Interchange.” Read the blog post here.

(Source: Angelo Tinazzi, Cytel, 10/5/21)