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Showing posts with the label ADaM

SAS Interview Questions and Answers: CDISC, SDTM and ADAM etc

1) What do you know about CDISC and its standards? CDISC stands for Clinical Data Interchange Standards Consortium and it is developed keeping in mind to bring great deal of efficiency in the entire drug development process. CDISC brings efficiency to the entire drug development process by improving the data quality and speed-up the whole drug development process and to do that CDISC developed a series of standards, which include Operation data Model (ODM), Study data Tabulation Model (SDTM) and the Analysis Data Model ADaM ). 2) Why people these days are more talking about CDSIC and what advantages it brings to the Pharmaceutical Industry? A) Generally speaking, Only about 30% of programming time is used to generate statistical results with SAS®, and the rest of programming time is used to familiarize data structure, check data accuracy, and tabulate/list raw data and statistical results into certain formats. This non-statistical programming time will be significantly reduced...

CDISC and its IMPLEMENTATION

An Introduction to CDISC: CDISC: Why SAS® Programmers Need to Know CDISC Implementation Step by Step: A Real World Example A Toolkit for CDISC Implementation CDISC standards How to test CDISC Operation data Model (ODM) in SAS Creating Case Report Tabulations (CRTs) for an NDA Electronic Submission to the FDA Implementation Guide Study Data Tabulation Model Update on CDISC Study Data Tabulation Model Practical Methods for Creating CDISC SDTM Domain Data Sets from Existing Data SAS® Dataset Content Conversion to CDISC Data Standards IMPLEMENTATION OF CDISC STANDARDS Sample CRF's and Protocol CRFs (PDF - 773.4 KB) Protocol (PDF - 2.0 MB) direct link: https://biolincc.nhlbi.nih.gov/studies/