This is an example of a CRF used to collect vital signs.
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title | CDASH VS Metadata Specifications |
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Metadataspec |
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Order | Question Text | Prompt | CRF Completion Instructions |
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CDASH Variable Name | SDTMIG Target Variable | SDTM Target MappingType | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
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1 | What was the date of the measurements? | Date | Record date of measurements | using this format . | Date | VSDAT | VSDTC |
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| 2 | What was the time of the measurements? | Time | Record time of measurement. | Time | VSTIM | VSDTC |
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| 3 | What was the result of the height measurement? | Height | Record the height result. | Float | HEIGHT | VSORRES | VSORRES where VSTESTCD = "HEIGHT" |
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| 4 | What was the unit of the height measurement? | Height Unit | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | Text | HEIGHTU | VSORRESU | VSORRESU where VSTESTCD = "HEIGHT" | (VSRESU) | cm in iinch |
| 5 | What was the result of the weight measurement? | Weight | Record the weight result. | Float | WEIGHT | VSORRESS |
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| 6 | What was the unit of the weight measurement? | Weight Unit | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | Text | WEIGHTU | VSORRESU | VSORRESU where VSTESTCD = "WEIGHT" | (VSRESU) | kg LBPound |
| 7 | What was the result of the temperature measurement? | Temperature | Record the temperature result. | Float | TEMP | VSORRES | VSORRES where VSTESTCD = "TEMP" |
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| 8 | What was the unit of the temperature measurement? | Temperature Unit | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | Text | TEMPU | VSORRESU | VSORRESU where VSTESTCD = "TEMP" | (VSRESU) | C FFahrenheit |
| 9 | What was the result of the respiratory rate measurement? | Respiratory Rate | Record the respiratory rate result. | Float | RESP | VSORRES | VSORRES where VSTESTCD = "RESP" |
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| 10 | What was the unit of the respiratory rate measurement? | Respiratory Rate Unit | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | Text | RESPU | VSORRESU | VSORRESU where VSTESTCD = "RESP" | (VSRESU) |
| breaths/min | 11 | What was the result of the systolic blood pressure measurement? | Systolic Blood Pressure | Record the systolic blood pressure result. | Integer | SYSBP | VSORRES | VSORRES where VSTESTCD = "SYSBP" |
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| 12 | What was the unit of the systolic blood pressure measurement? | Systolic Blood Pressure Unit | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | Text | SYSBPU | VSORRESU | VSORRESU where VSTESTCD = "SYSBP" | (VSRESU) |
| mmHg | 13 | What was the result of the diastolic blood pressure measurement? | Diastolic Blood Pressure | Record the diastolic blood pressure result. | Integer | DIABP | VSORRES | VSORRES where VSTESTCD = "DIABP" |
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| 14 | What was the unit of the diastolic blood pressure measurement? | Diastolic Blood Pressure Unit | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | Text | DIABPU | VSORRESU | VSORRESU where VSTESTCD = "DIABP" | (VSRESU) |
| mmHg | 15 | What was the result of the pulse measurement? | Pulse Rate | Record the pulse rate result. | Integer | PULSE | VSORRES | VSORRES where VSTESTCD = "PULSE" |
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| 16 | What was the unit of the pulse rate measurement? | Pulse Rate Unit | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | Text | PULSEU | VSORRESU | VSORRESU where VSTESTCD = "PULSE" | (VSRESU) |
| beats/min |
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