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

Validation checks or tools to check the compliance of SDTM data JANUS is a standard database model which is based on the CDISC’s SDTM standard. JANUS is used by the FDA to store the submitted SDTM clinical data. As a part of data definition file submission pharmaceutical companies have to submit SAS datasets in transport file ( . xpt ) format along with annotated CRF and Define.xml file. The reason being this is… to properly load the clinical data into JANUS database which is maintained by the FDA. It is very easy for FDA reviewers to review the clinical data once they load the clinical data into their JANUS database. They can even produce ad-hoc reports and perform cross-study review at the same time. FDA runs compliance checks on the data submitted to make sure the data was collected as per the SDTM standard. FDA checks the compliance of data by running the WebSDM™ developed by PhaseForward ). WebSDM™ is a SDTM compliance check validation tool performs a set of SDTM c...

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...