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.
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| title | CDASH IC MH Metadata Specifications |
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| Metadataspec |
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Section 1 | Order | CDASH Variable Name | Question Text | Prompt | CRF Case Report Form Completion Instructions | SDTMIG Target Variable | SDTM Target Mapping | Type | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
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| 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. | Text | MHYN | N/A | Not Submitted | (NY) | Yes; No | No;Yes |
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Section 2 | Order | Question Text | Prompt | Case Report Form Completion Instructions | Type | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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| 2 | What is the category? | 2 | MHCAT | Medical History Category |
| Text | 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 | Text | MHSPID | MHSPID |
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| | 4MHTERM | 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. | Text | MHTERM | MHTERM |
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| | 5 | MHSTDAT | 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). | Date | MHSTDAT | MHSTDTC |
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| | 6MHONGO | 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. | Text | MHONGO | MHENRF/ MHENRTPT | MHENRF or MHENRTPT | (NY) | No;Yes; No |
| | 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). | Date | MHENDTC | MHENDAT |
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