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THE REFERENCES FOR More information can be found in SDTMIG Section 4.4.7, Relative Timing Variables needs to be linked to a Section in this TIG. This section seems to be missing. |
In this example, a General Medical History CRF collected verbatim descriptions of any medical conditions or events experienced by the subject.
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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 applicant to use either MHENRF or MHENRTPT to represent an event that was ongoing. This SDTM dataset used uses MHENRTPT. More information can be found in SDTMIG Section 4.4.7, Relative Timing Variables. (For more information, see Section 2.8.7.6, Representing References and Relative Timing.)
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| 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, (i.e., the date the information was collected). If "Yes" was specified for Ongoing, MHENRTPT = "ONGOING"; if "No" was checked, MHENRTPT = "BEFORE". | | Row 3: | The Displays the start and end date of the reported reported event was displayed. | |
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| Row | STUDYID | DOMAIN | USUBJID | MHSEQ | MHSPID | MHTERM | MHDECOD | 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 |
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