Alpha Traore
Biostistician at Biostat Consultant Inc.
Abstract:
I will discuss my internship experience at QST Consultations.
The company is a contract research organization based in Allendale, MI
that provides data management and statistical analysis
services to the drug development industry.
I will introduce some important practices in Contract Research Organizations
to the neophyte.
Secondly, I will talk about the Clinical Data Interchange Standards Consortium (CDISC)
and explain some of the implementation guide.
Data standards provide a general framework for organizing study data
in order to facilitate the exchange of data between computer systems.
These include templates for datasets, standardizing names for variables, and
standardizing ways of doing calculations with common variables.
CDISC developed a set of standards supported by the FDA,
including the Study Data Tabulation Model (SDTM)
and the Analysis Data Model (ADaM) for analysis of
clinical data.
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All statistics graduate students are expected to attend.