) 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.1) What do you know about CDISC and its standards?ĬDISC 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 after implementing the CDISC standards. 3) What are the challenges as SAS programmer you think you will face when you first implement CDISC standards in you company? A) With the new requirements of electronic submission, CRT datasets need to conform to a set of standards for facilitating reviewing process. They no longer are created solely for programmers convenient.
SDS will be treated as specifications of datasets to be submitted, potentially as reference of CRF design. Therefore, statistical programming may need to start from this common ground.
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