Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies

<table class="table-group" id="tab2"><tr><td><table class="table"><tr><td class="thead-hr" colspan="3"><hr/></td></tr><tr class="thead"><td align="left">SDTM</td><td align="center">SALUS CDE</td><td align="center">HITSP C154</td></tr><tr><td class="thead-hr" colspan="3"><hr/></td></tr><tr><td align="left">DM</td><td align="center">Patient</td><td align="center">Personal Information</td></tr><tr><td align="left">DM.DMSEX</td><td align="center">Patient.Gender.CD</td><td align="center">1.06 Personal Information Gender</td></tr><tr><td align="left">MH</td><td align="center">Patient.Condition.Condition</td><td align="center">Conditions</td></tr><tr><td align="left">MH.MHPTCD</td><td align="center">Condition.ProblemCode.CD</td><td align="center">7.04 Conditions Problem Code</td></tr><tr><td align="left">MH.MHSTDTC</td><td align="center">Condition.TimeInterval.IVLTS</td><td align="center">7.01 Conditions Problem Date</td></tr><tr class="table-tr"><td colspan="3"><hr class="tbody-hr"/></td></tr></table></td></tr></table>

Mappings of the common data elements: SDTM, SALUS CDE set, and HITSP C154 Data Dictionary.

BioMed Research International

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Table 2

Table 2: Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies 