Download Easy Button: A Process for Generating Standardized Safety

Transcript
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.
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