| Order | CDASH Variable Name | Question Text | Prompt | CRF Completion Instructions | CDASH Variable Name | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
|---|
| 1MHYN | Has the subject had any medical conditions or events? | Any Medical History | Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF. | MHYN | N/A |
| (NY) | Yes; No |
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| 2 | MHCAT |
| Medical History Category |
| MHCAT | MHCAT |
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| GENERAL MEDICAL HISTORY |
| 3MHSPID | What is the medical condition or event identifier? | MH Number | Applicant-Defined CRF Completion Instructions | MHSPID | MHSPID |
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| 4 | MHTERM | What is the medical condition or event term? | Medical History Term | Record 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. | MHTERM | MHTERM |
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| 5MHSTDAT | What was the medical condition or event start date? | Start Date | Record the start date of the medical event or condition using this format (DD-MON-YYYY). | MHSTDAT | MHSTDTC |
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| 6 | MHONGO | Is the medical condition or event ongoing? | Ongoing | Record 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. | MHONGO | MHENRF/ MHENRTPT |
| (NY) | Yes; No |
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| 7 | MHENDAT | What was the medical condition or event end date? | End Date | Record the end date of the medical event or condition using this format (DD-MON-YYYY). | MHENDAT | MHENDTC |
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