The Medical History (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 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.)
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