#Sas interview questions in sdtm trial#
#Sas interview questions in sdtm series#

There will be a list of standard variables and names for each and every dataset. There will be standard domain names and standard structure for each domain. This process will delay the drug development process as such. Reviewers will have spent most of the valuable time in cleaning up the data into a standard format rather than reviewing the data for the accuracy. There is no standard variables list for each and every domain.Д«ecause of this FDA reviewers always had to take so much pain in understanding themselves with different data, domain names and name of the variable in each analysis dataset. There are different names for each domain and domains donвЂ™t have a standard structure. According to the CDISC standard, there are four ways to represent a subject in a clinical study: tabulations, data listings, analysis datasets, and subject profiles6.

#Sas interview questions in sdtm trial#

In July 2004 the Clinical Data Interchange Standards Consortium (CDISC) published standards on the design and content of clinical trial tabulation data sets, known as the Study Data Tabulation Model (SDTM). SDTM stands for Standard data Tabulation Model, which defines a standard structure for study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA) 2.

It is a time to expand and enhance the job skills from various aspects under new change so that SASВ® programmers can take a competitive advantage, and continue to play a main role in both statistical analysis and reporting for drug development.ДЎ) What do you understand about SDTM and its importance? With the new requirements from updating electronic submission and CDISC implementation, understanding only SASВ® may not be good enough to fulfill for final deliverables. All existing programs/macros may also need to be remapped based on CDISC so one can take advantage to validate submission information by using tools which reviewer may use for reviewing and to accelerate reviewing process without providing unnecessary data, tables and listings. Therefore, statistical programming may need to start from this common ground. SDS will be treated as specifications of datasets to be submitted, potentially as reference of CRF design. They no longer are created solely for programmers convenient.

This non-statistical programming time will be significantly reduced after implementing the CDISC standards.ДЈ) What are the challenges as SAS programmer you think you will face when you first implement CDISC standards in you company?ДЄ) With the new requirements of electronic submission, CRT datasets need to conform to a set of standards for facilitating reviewing process.

#Sas interview questions in sdtm series#

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).Дў) Why people these days are more talking about CDSIC and what advantages it brings to the Pharmaceutical Industry?ДЄ) Generally speaking, Only about 30% of programming time is used to generate statistical results with SASВ®, 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. 1) What do you know about CDISC and its standards?Д¬DISC 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.