Transcription of 207-2008: Practical Methods for Creating CDISC SDTM ... - SAS
{{id}} {{{paragraph}}}
Example: stock market
207-2008: Practical Methods for Creating CDISC SDTM ... - SAS
1 Paper 207-2008 Practical Methods for Creating CDISC sdtm Domain Data Sets from existing Data Robert W. Graebner, Quintiles, Inc., Overland Park, KS ABSTRACT Creating CDISC sdtm domain data sets from existing clinical trial data can be a challenging task, particularly if the database was not designed with the sdtm standards in mind. A key step in the process involves determining which of the STDM domain datasets need to be produced for submission and then determining what conversion process will be necessary to produce them from the existing data.
2. Determine the extent of SDTM compliance in the existing data 3. Implement automaic direct mapping where possible 4. Map remaining source data sets to SDTM domains 5. Map variables in source data sets to SDTM domain variables 6. Determine if SUPPQUAL domain or custom domains will be required 7. Generate SAS programs to perform the data ...
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: