Download Easy Button: A Process for Generating Standardized Safety
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SAS Global Forum 2013 Pharma and Health Care Below is an example of %ae_reporting macro specification: References: Type Element Location Main Program Program(s) Called ae_reporting.sas t-aept.sas t-aesocpt.sas ----------------t-aesummary.sas ...\Reporting Event\macrolib ...\Reporting Event\tables Macro(s) selpop trtmapping ------------cntfrqbyvar ...\Reporting Event\macrolib Data Sources: Data Set Description Required Variables Required Formats Adsl Adae Population Adverse Events &_usubjid., &_trtcd. &_usubjid. aedecod, aebodsys &_trtfmt. (&_trtcd.) Note(s): 1. Variables usubjid and trt01an are the default variable names associated to the macro variables &_usubjid and &_trtcd. The macro variables are created and assigned in the study initialization file (…\Reporting Event\standard.sas). 2. ADaM datasets located in directory …\Reporting Event\data\analysis and SDTM datasets located in directory …\Reporting Event\data\sdtm. 2