Versions Compared

Key

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

The medical history of subjects enrolled in studies on tobacco use if often collected. . This is an example SDTM dataset used to represent the medical history collected on the above CRF. This CRF was designed to allow the applicant to use either MHENRF or MHENRTPT to represent an event that was ongoing. This SDTM dataset uses MHENRTPT. (For more information, see Section 2.8.7.6, Representing References and Relative Timing.)

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 Medical History CRF. MHENTPT displays the reference date for MHENRTPT (i.e., the date the information was collected). If "Yes" was specified for Ongoing, MHENRTPT = "ONGOING"; if "No" was checked, MHENRTPT = "BEFORE". 
Row 3:Displays the start and end date of the reported event.
Dataset2
MHMODIFYMHDECODMHEVDTYPMHPRESPMHOCCURMHDTCMHSTDTCPACA001001Angina2019--162018-10-12
RowSTUDYIDDOMAINUSUBJIDMHSEQMHSPIDMHTERM
MHDECOD
MHCAT
MHBODSYS
MHSTDTC
MHENDTC
MHENRTPT
MHENTPT
1
ABC123MH
1231011
01
2017-10-142PACA001MH0012Hypertension YY2019-01-162017-11-22 3PACA001MH0013Depression YN2019-01-164PACA001MH0014 DiabetesYN2019-01-165PACA001MH00312019-01-162018-11-166PACA001MH00512019-01-16
ASTHMAAsthmaGENERAL MEDICAL HISTORYRespiratory system disorders2003
ONGOING2004-09-18
2ABC123MH123101202FREQUENT HEADACHESHeadacheGENERAL MEDICAL HISTORYCentral and peripheral nervous system disorders2004-07
ONGOING2004-09-18
3ABC123MH123101303BROKEN LEGBone fractureGENERAL MEDICAL HISTORYMusculoskeletal system disorders2005-07-152005-08-31