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). References: Pharmasug/2007/fc/fc05 pharmasug/2003/fda compliance/fda055 1) What do you understand about SDTM and its importance? 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 SAS® programmers can take a competitive advantage, and continue to play a main role in both statistical analysis and reporting for drug development. With the new requirements from updating electronic submission and CDISC implementation, understanding only SAS® 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. 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. This non-statistical programming time will be significantly reduced after implementing the CDISC standards. 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. 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). ) 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.
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