Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

This is an example of an SDTM dataset used to represent the medical history collected on the above CRF.  This CRF was designed to allow the sponsor to elect to use either MHENRF/ MHENRTPT to represent an event that was ongoing. This SDTM dataset used MHENRTPT. More information can be found in  SDTMIG Section 4.4.7, Use of Relative Timing Variables

Dataset wrap
Namemh
Rowcaps
Rows 1-2:The reported events were coded using a standard dictionary. MHDECOD and MHBODSYS display the preferred term and body system assigned through the coding process. MHENRTPT was populated based on the response to the "Ongoing" question on the General Medical History CRF. MHENTPT displays the reference date for MHENRTPT, that is, the date the information was collected. If "Yes" was specified for Ongoing, MHENRTPT = "ONGOING"; if "No" was checked, MHENRTPT = "BEFORE". See Section 4.4.7, Use of Relative Timing Variables, for further guidance. 
Row 3:The  start and end date of the reported  event was displayed.
Dataset2
RowSTUDYIDDOMAINUSUBJIDMHSEQMHTERMMHDECODMHCATMHBODSYSMHSTDTCMHENDTCMHENRTPTMHENTPT
1ABC123MH1231011ASTHMAAsthmaGENERAL MEDICAL HISTORYRespiratory system disorders2003
ONGOING2004-09-18
2ABC123MH1231012FREQUENT HEADACHESHeadacheGENERAL MEDICAL HISTORYCentral and peripheral nervous system disorders2004-07
ONGOING2004-09-18
3ABC123MH1231013BROKEN LEGBone fractureGENERAL MEDICAL HISTORYMusculoskeletal system disorders2005-07-152005-08-31