**StudySAS Blog: Mastering Clinical Data Management with SAS**

Here is the nice article about creating custom SDTM domains......... Creating Custom or Non-Standard CDISC SDTM Domains Within the  Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) , standard domains are split into four main types: special purpose, relationships, trial design and general observation classes. General observation classes cover the majority of observations collected during a study and can be divided among three general classes: The Interventions class captures investigational , therapeutic and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., “exposure”), coincident with the study assessment period (e.g., “concomitant medications”), or other substances self-administered by the subject (such as alcohol, tobacco, or caffeine). The Events class captures planned protocol milestones such as randomization and study co...

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...

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/

Why is the adoption of the CDISC standards important for the life sciences industry and what is SAS' relationship with CDISC? A: The Clinical Data Interchange Standards Consortium (CDISC) is fundamentally changing the way information is being managed in the life sciences research industries, and is beginning to change the way the US Food and Drug Administration (FDA) reviews new drug applications. Historically, most pharmaceutical organizations developed their own internal data standards, and associated processing, for managing research information. Each organization's unique approach to this information management process has done little to expedite the overall new drug development process, and in many ways has slowed it down - by requiring each organization to spend unnecessary effort acquiring, developing and implementing distinct processes. Furthermore, the submission of research data in nonstandardized formats makes it difficult for the FDA to develop standard, efficient, ...