In this example, a General Medical History CRF collected verbatim descriptions of any medical conditions or events experiences by the subject.
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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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| Rows 1Rows 1-32: | 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(i.e., 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: | Displays the start and end date of the reported event. | |
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| Row | STUDYID | DOMAIN | USUBJID | MHSEQ | MHSPID | MHTERM | MHDECOD | MHEVDTYP | MHCAT | MHBODSYS | MHSTDTC | MHENDTC | MHENRTPT | MHENTPT |
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| 1 | ABC123 | MH | 123101 | 1 | 01 | ASTHMA | Asthma | GENERAL MEDICAL HISTORY | Respiratory system disorders | 2003 |
| ONGOING | 2004-09-18 | | 2 | ABC123 | MH | 123101 | 2 | 02 | FREQUENT HEADACHES | Headache | GENERAL MEDICAL HISTORY | Central and peripheral nervous system disorders | 2004-07 |
| ONGOING | 2004-09-18 | | 3 | ABC123 | MH | 123101 | 3 | 03 | BROKEN LEG | Bone fracture | GENERAL MEDICAL HISTORY | Musculoskeletal system disorders | 2005-07-15 | 2005-08-31 | E |
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