CDE Detailed Report
Disease: content
Subdomain Name: General Health History
CRF: welcome
Displaying 1 - 29 of 29
Subdomain Name: General Health History
CRF: welcome
Displaying 1 - 29 of 29
| CDE ID | CDE Name | Variable Name | Definition | Short Description | Question Text | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C59019 | Birth weight measurement | BirthWeightMeasr | Measurement in kilograms of the weight of a neonate at birth | Measurement in kilograms of the weight of a neonate at birth | Birth weight | Numeric Values |
Recorded value of participant's/subject's measured weight at birth. This element is intended for pediatric clinical studies. Record the birth weight of the participant/ subject in kilograms (Kg) |
No references available | Pediatric | Supplemental-Highly Recommended | 1.10 | 2022-08-01 10:17:22.0 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Free-Form Entry |
0 | 9000 | kilograms | 3201400;2179689 | ||||||
| C12604 | APGAR one minute score | APGAR1MinScore | Score of a newborn recorded at one minute from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsiveness | Score of a newborn recorded at one minute from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsivenes | APGAR 1 minute score | 0;1;2;3;4;5;6;7;8;9;10 | 0;1;2;3;4;5;6;7;8;9;10 | Numeric Values |
Record the APGAR score (0 - 10 points, inclusive) assessed at 1 minute. |
No references available | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-24 11:38:01.2 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C16055 | Full term delivery child indicator | FullTrmDelChldInd | Indicates whether the participant's/subject's child was delivered full-term | Indicates whether the participant's/subject's child was delivered full-term | Was the child delivered full-term (>36 weeks)? | Yes;No | Yes;No | Alphanumeric |
No instructions available |
No references available | Pediatric | Exploratory | 3.00 | 2013-07-16 14:01:43.01 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C58820 | Pregnancy or delivery risk factor status | PregDeliveryRiskFactStat | The status of the participant/subject when the specific risk factor was experienced either during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery | The status of the participant/subject when the specific risk factor was experienced either during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after deliver | If YES, specify | Prenatal;Perinatal;Postnatal | Prenatal;Perinatal;Postnatal | Alphanumeric |
No instructions available |
No references available | Pediatric | Supplemental-Highly Recommended | 1.00 | 2020-05-15 11:46:12.0 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Multiple Pre-Defined Values Selected |
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| C58821 | Pregnancy or delivery risk factor illness other text | PregDeliveryRiskFactIllOthrTxt | The free-text field related to 'Pregnancy or delivery risk factor type' specifying other illness text. Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery | The free-text field related to 'Pregnancy or delivery risk factor type' specifying other illness text. Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnant), | If YES, specify illness(es) | Alphanumeric |
No instructions available |
No references available | Pediatric | Supplemental-Highly Recommended | 1.00 | 2020-05-15 12:38:41.0 | Pregnancy and Perinatal History | General Health History | Participant History and Family History | 255 |
Free-Form Entry |
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| C58823 | Pregnancy or delivery risk factor fetal abnormal recognize in utero text | PregDlvRskFactFetlAbnRcgUtrTxt | The free-text field related to 'Pregnancy or delivery risk factor type' specifying the fetal abnormality(ies) recognized in utero. Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery | The free-text field related to 'Pregnancy or delivery risk factor type' specifying the fetal abnormality(ies) recognized in utero. Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., d | If YES, specify abnormality(ies) | Alphanumeric |
No instructions available |
No references available | Pediatric | Supplemental-Highly Recommended | 1.00 | 2020-05-15 12:45:28.0 | Pregnancy and Perinatal History | General Health History | Participant History and Family History | 255 |
Free-Form Entry |
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| C58824 | Pregnancy or delivery risk factor maternal infection text | PregDelivrRiskFactMatInfectTxt | The free-text field related to 'Pregnancy or delivery risk factor type' specifying maternal infection(s). Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery | The free-text field related to 'Pregnancy or delivery risk factor type' specifying maternal infection(s). Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnan | If YES, specify infections(s) | Alphanumeric |
No instructions available |
No references available | Pediatric | Supplemental-Highly Recommended | 1.00 | 2020-05-15 12:50:57.0 | Pregnancy and Perinatal History | General Health History | Participant History and Family History | 255 |
Free-Form Entry |
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| C58825 | Intracranial aneurysm rupture delivery status | IARuptDeliveryStat | The element related to the time when the rupture of the brain aneurysm occurred, either before, during or after delivery | The element related to the time when the rupture of the brain aneurysm occurred, either before, during or after deliver | Timing of intracranial aneurysm rupture during pregnancy | After delivery;Before delivery;During delivery | After delivery;Before delivery;During delivery | Alphanumeric |
No instructions available |
No references available | Pediatric | Exploratory | 1.00 | 2020-05-15 12:53:46.0 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C00007 | Birth date | BirthDate | Date (and time, if applicable and known) the participant was born | Date (and time, if applicable and known) the participant was born | Date of delivery | Date or Date & Time |
No instructions available |
No references available | Pediatric | Core | 3.1 | 10/16/2024 8:51:14 AM | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Free-Form Entry |
793 | |||||||||
| C11066 | Pregnancy or delivery risk factor type | PregnDeliveryRiskFactTyp | Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery | Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery | Did the mother experience any of the following during the prenatal period, at the time of delivery, or soon after delivery with the participant/subject | Preeclampsia;Other hypertensive disorder;Oligohydramnios;Gestational diabetes;Prolonged rupture of membranes during delivery;Chorioamnionitis;Other illness(es);Decreased fetal movement;Fever during delivery of participant/subject;Meconium staining of the amniotic fluid;Intravascular catheter placed in newborn period;Placenta sent for pathology;Placental abnormalities;Fetal heart rate abnormality;Other, specify;Fetal abnormalities recognized in utero;Maternal infection;Lack of prenatal care;Maternal drug abuse | Preeclampsia;Other hypertensive disorder;Oligohydramnios;Gestational diabetes;Prolonged rupture of membranes during delivery;Chorioamnionitis;Other illness(es);Decreased fetal movement;Fever during delivery of participant/subject;Meconium staining of the amniotic fluid;Intravascular catheter placed in newborn period;Placenta sent for pathology;Placental abnormalities;Fetal heart rate abnormality;Other, specify;Fetal abnormalities recognized in utero;Maternal infection;Lack of prenatal care;Maternal drug abuse | Alphanumeric |
For each pregnancy condition record whether the mother experienced it using the element "Pregnancy or delivery risk factor indicator". |
No references available | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Multiple Pre-Defined Values Selected |
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| C00001 | Gestational age value | GestatnlAgeVal | Time elapsed in weeks between the first day of the last normal menstrual period and the day of delivery of the participant/subject | Time elapsed in weeks between the first day of the last normal menstrual period and the day of delivery of the participant/subjec | Gestational age at birth | Numeric Values |
Gestational age at birth should be recorded in weeks and can be obtained from family or medical record/ chart. This element should be collected along with the other elements of the Sophia Classification. Recommended for Neonates ONLY (i.e., not appropriate for Children). |
Govaert P, Ramenghi L, Taal R, de Vries L, Deveber G. Diagnosis of perinatal stroke I: definitions, differential diagnosis and registration. Acta Paediatr. 2009;98(10):1556-1567. | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Free-Form Entry |
0 | 52 | week | 3192017 | ||||||
| C11067 | Pregnancy or delivery risk factor indicator | PregDeliveryRiskFactInd | Whether the specific risk factor to the participant's/subject's health was experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery | Whether the specific risk factor to the participant's/subject's health was experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery | Did the mother experience any of the following during the prenatal period, at the time of delivery, or soon after delivery with the participant/subject | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Choose one for each condition (see "Pregnancy or delivery risk factor type" CDE). |
No references available | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C00723 | APGAR ten minute score | APGARTenMinuteScore | Score of a newborn recorded at ten minutes from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsiveness | Score of a newborn recorded at ten minutes from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsivenes | APGAR 10 minute score | 0;1;2;3;4;5;6;7;8;9;10 | 0;1;2;3;4;5;6;7;8;9;10 | Numeric Values |
Record the APGAR score (0 - 10 points, inclusive) assessed at 10 minutes |
No references available | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
3181701 | |||||||
| C11078 | Delivery mode type | DeliveryModeTyp | Type of delivery mode of the neonate | Type of delivery mode of the neonate | Mode of delivery of the neonate | Spontaneous;Induced, specify reason;Unknown | Spontaneous;Induced, specify reason;Unknown | Alphanumeric |
Choose one. |
No references available | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C00724 | APGAR five minute score | APGARFiveMinuteScore | Score of a newborn recorded at five minutes from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsiveness | Score of a newborn recorded at five minutes from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsivenes | APGAR 5 minute score | 0;1;2;3;4;5;6;7;8;9;10 | 0;1;2;3;4;5;6;7;8;9;10 | Numeric Values |
Record the APGAR score (0 - 10 points, inclusive) assessed at 5 minutes |
No references available | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
2738533 | |||||||
| C11079 | Neonate delivery route type | NeonateDelivRteTyp | Route of delivery of the neonate | Route of delivery of the neonate | Route of delivery of the neonate | Vaginal;Caesarean;Unknown | Vaginal;Caesarean;Unknown | Alphanumeric |
Choose one. |
No references available | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C06005 | Data collected date and time | DataCollDateTime | Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed | Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performe | Date family history taken | Date or Date & Time |
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.). |
No references available | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-24 21:00:23.88 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Free-Form Entry |
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| C11080 | Delivery modality type | DeliveryModltyTyp | Type of modality of the participant/subject's intrauterine orientation at delivery | Type of modality of the participant/subject's intrauterine orientation at delivery | Delivery modality type of the neonate | Breech;Cephalic;Unknown;Other | Breech;Cephalic;Unknown;Other | Alphanumeric |
Choose one. |
No references available | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C10556 | Pregnant ever indicator | PregEverInd | Indicator as to whether or not the participant/subject has every been pregnant, both term and not to term | Indicator as to whether or not the participant/subject has every been pregnant, both term and not to term | Prior pregnancy | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-16 14:01:43.01 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C11081 | Delivery caesarean timing status | DeliveryCaesareanTimingStatus | Status of the caesarean delivery | Status of the caesarean delivery | If caesarean, timing of the caesarean | Emergency;Elective;Unknown | Emergency;Elective;Unknown | Alphanumeric |
Choose one. Element is only applicable if "Delivery route" is answered as "Caesarean". |
No references available | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-16 14:01:43.01 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C10558 | Delivery or pregnancy termination last date and time | DeliveryPregTerminLstDateTime | Date (and time if applicable and known) the female participant/subject last delivered a pregnancy or the pregnancy terminated (e.g., miscarriage, abortion) | Date (and time if applicable and known) the female participant/subject last delivered a pregnancy or the pregnancy terminated (e.g., miscarriage, abortion) | Year of last delivery / miscarriage/ medical termination | Date or Date & Time |
Enter 4-digit year (YYYY) at a minimum. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.). |
No references available | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-16 14:01:43.01 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Free-Form Entry |
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| C11083 | Delivery extraction type | DeliveryExtractionTyp | Type of extraction used to assist with the delivery of the participant/subject | Type of extraction used to assist with the delivery of the participant/subject | Instrument(s) used to assist with the delivery of the participant/subject | None;Vacuum;Forceps;Vacuum and Forceps;Unknown | None;Vacuum;Forceps;Vacuum and Forceps;Unknown | Alphanumeric |
Choose one. |
No references available | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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| C10559 | Spontaneous miscarriage count | SpontaneousMiscarriageCt | Value representing the number of times the participant/subject has had miscarriages or spontaneous abortions, including all trimesters | Value representing the number of times the participant/subject has had miscarriages or spontaneous abortions, including all trimesters | Number of miscarriages | Numeric Values |
Enter integer number of spontaneous abortions/ miscarriages. |
No references available | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-11 15:03:49.2 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Free-Form Entry |
0 | 99 | ||||||||
| C14151 | Pregnancy medical terminations count | PregMedTerminationCt | Number of medical terminations (abortions) | Number of medical terminations (abortions) | Number of medical terminations | Numeric Values |
Enter integer number of medical terminations/ abortions. |
No references available | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-06-21 00:00:00.0 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Free-Form Entry |
0 | 99 | ||||||||
| C11062 | Maternal delivery age value | MatrnlDelvryAgeVal | Mother's age at the time she gave birth to the participant/subject | Mother's age at the time she gave birth to the participant/subject | Mother'?s age at the time she gave birth to the participant/subject | Numeric Values |
Enter the mother's age in years. Record the value as an integer. |
No references available | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-24 21:00:23.88 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Free-Form Entry |
0 | 99 | year | |||||||
| C18819 | Pregnancy or delivery risk factor other text | PregnDeliveryRiskFactOTH | The free-text field related to 'Pregnancy or delivery risk factor type' specifying other text. Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery | The free-text field related to 'Pregnancy or delivery risk factor type' specifying other text. Type of risk factor that may have been experienced during the prenatal period, at the time of delivery, or soon after delivery | Other, specify | Alphanumeric |
For each pregnancy condition record whether the mother experienced it using the element "Pregnancy or delivery risk factor indicator". |
No references available | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Pregnancy and Perinatal History | General Health History | Participant History and Family History | 4000 |
Free-Form Entry |
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| C11063 | Parity maternal value | ParityMaternalVal | Number of live born children the participant's/subject's mother has delivered | Number of live born children the participant's/subject's mother has delivered | Number of live born children the participant/subject'?s mother has delivered | Numeric Values |
Enter integer number of live births. |
No references available | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-10 11:37:29.993 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Free-Form Entry |
0 | 99 | ||||||||
| C18829 | Delivery mode induced other text | DeliveryModeOTH | The free-text field related to 'Delivery mode type' for induced delivery mode. Type of delivery mode of the neonate | The free-text field related to 'Delivery mode type' for induced delivery mode. Type of delivery mode of the neonate | Induced, specify reason | Alphanumeric |
Choose one. |
No references available | Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Pregnancy and Perinatal History | General Health History | Participant History and Family History | 4000 |
Free-Form Entry |
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| C11065 | Gravida maternal value | GravidaMaternalVal | Total number of times the participant's/subject's mother has been pregnant, regardless of whether these pregnancies were carried to term | Total number of times the participant's/subject's mother has been pregnant, regardless of whether these pregnancies were carried to term | Number of prior pregnancies | Numeric Values |
Enter integer number of times woman has been pregnant. |
No references available | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Pregnancy and Perinatal History | General Health History | Participant History and Family History |
Free-Form Entry |
1 | 99 |
