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The Medical History (MH) domain is based on the Events General Observation class. The MH domain is used to represent information collected about medical conditions that started prior to the start of the study. The study timepoint at which events stop being pre-study events (medical history) is determined by the sponsor according to the requirements of the study. However, the "stop" timepoint may be no earlier than the date of informed consent (which is recorded for each subject in the RFICDTC variable in the DM domain) and no later than the start date of the Study Reference Period (which is recorded for each subject in the RFSTDTC variable in the DM dataset).  The timepoint is usually identifiable as the point at which medical history information is collected; medical conditions starting after the collection of medical history information are often considered to be on-study events. Note that the relative timing variables used to represent medical history events as being "prior" or "ongoing" will depend on whether the collection of medical history information coincides with the start of the study reference period. 

Example

This is an example Medical History CRF. This CRF collects verbatim descriptions of any medical conditions or events experienced by the subject. This CRF was designed to allow the applicant to use either MHENRF or MHENRTPT to represent an event was ongoing.


Section 1 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1Has the subject had any medical conditions or events?Any Medical HistoryIndicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.TextMHYNN/ANot Submitted(NY)No;Yes

Section 2 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
2What is the category?Medical History Category
TextMHCATMHCAT

GENERAL MEDICAL HISTORY
3What is the medical condition or event identifier?MH NumberApplicant-Defined CRF Completion InstructionsTextMHSPIDMHSPID



4What is the medical condition or event term?Medical History TermRecord all relevant medical conditions or events, as defined in the protocol. Record only one medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria.TextMHTERMMHTERM



5What was the medical condition or event start date?Start DateRecord the start date of the medical event or condition using this format (DD-MON-YYYY).DateMHSTDATMHSTDTC



6Is the medical condition or event ongoing?OngoingRecord the medical condition or event as ongoing (Yes) if it has not ended at the time of data collection; the end date should be left blank.TextMHONGOMHENRF/  MHENRTPTMHENRF or  MHENRTPT(NY)No;Yes
7What was the medical condition or event end date?End DateRecord the end date of the medical event or condition using this format (DD-MON-YYYY).DateMHENDTCMHENDAT



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.)
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.

mh.xpt

mh.xpt

RowSTUDYIDDOMAINUSUBJIDMHSEQMHSPIDMHTERMMHDECODMHCATMHBODSYSMHSTDTCMHENDTCMHENRTPTMHENTPT
1ABC123MH123101101ASTHMAAsthmaGENERAL 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

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