This is an example of a CRF used to collect vital signs.
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| title | CDASH CM VS Metadata Specifications |
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| Metadataspec |
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CDASH Variable Name | Question Text | Prompt | CRF Completion Instructions |
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SDTMIG Target Variable | SDTM Target Mapping| Type | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
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| 1 | What |
is category the medication the subject used to attempt to reduce nicotine dependency? Medication Category | Record the type of medicaiton the subject used to reduce nicotine dependency. | Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF. | CMCAT | | the measurements? | Date | Record date of measurements. | 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) | centimeter; 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 |
NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; 2 | What is the subcategory for the medication? | Medication Subcategory | Record the medication subcategory the CMSCAT | LAST ATTEMPTED USE WITH THIS MEDICATION | | Text | WEIGHTU | VSORRESU | VSORRESU where VSTESTCD = "WEIGHT" | (VSRESU) | kilogram; Pound |
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3 name medication the subject used to reduce nicotine dependency? Medication | Record only one medication per line. Provide the full trade or proprietary name of the medication; otherwise, record the generic name. | Applicant-Defined CRF Completion Instructions | CMTRT | 4 | What was the duration of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration | Provide the duration of the medication used. | 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. | CMDUR | | 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) | Celsius; Fahrenheit |
| | 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) |
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5 | What was the duration unit of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration Unit | Select the appropriate duration unit of the medication used. | Record the start date of the medical event or condition using this format (DD-MON-YYYY). | CMDUR | DAYS; MONTHS; YEARS |
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