CDE Detailed Report
Subdomain Name: General Health History
CRF: content
Displaying 1 - 11 of 11
| 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). |
Pediatric Reference: Govaert P, Ramenghi L, Taal R, de Vries L, Deveber G. Diagnosis of perinatal stroke I: definitions, differential diagnosis and registration. Acta Paediatr. 2009 Oct;98(10):1556-67. | Pediatric | Supplemental | 1.10 | 2022-08-01 10:17:22.0 | Medical History | General Health History | Participant History and Family History |
Free-Form Entry |
0 | 9000 | kilograms | 3201400;2179689 | ||||||
| C00313 | Medical history condition SNOMED CT code | MedclHistCondSNOMEDCTCode | Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject | Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject | Medical History Term | Alphanumeric |
Core for Multiple Sclerosis studies The code related to the medical condition or disease reported using SNOMED CT codes (owned and administered by the International Health Terminology Standards Development Organisation) to enable data aggregation or sharing. |
SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html) | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Medical History | General Health History | Participant History and Family History | 255 |
Free-Form Entry |
|||||||||
| C00314 | Medical history taken date and time | MedclHistTakenDateTime | Date (and time, if applicable and known) the participant's medical history was taken | Date (and time, if applicable and known) the participant 's medical history was taken | Date medical history taken | Date or Date & Time |
Core for Multiple Sclerosis stuides Record the date (and time) the medical history was taken. 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 | Core | 3.20 | 2024-02-29 15:42:39.0 | Medical History | General Health History | Participant History and Family History |
Free-Form Entry |
2179659 | |||||||||
| C00315 | Medical history global assessment indicator | MedclHistGlobalAssmtInd | Indicator of whether the participant has a history of any medical problems/conditions | Indicator of whether the participant has a history of any medical problems/conditions | Does the participant/subject have a history of any medical problems/conditions in the following body systems | Yes;No | Yes;No | Alphanumeric |
Choose one. If this question is answered NO then the rest of the form is blank. If the question is answered YES then the medical history for at least one body system should be recorded. |
No references available | Adult;Pediatric | Supplemental | 3.10 | 2024-02-29 15:42:39.0 | Medical History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
3145578 | |||||||
| C00316 | Medical history condition end date and time | MedclHistCondEndDateTime | Date (and time, if applicable and known) for the end of an event in the participant's medical history | Date (and time, if applicable and known) for the end of an event in the participant's medical history | End Date | Date or Date & Time |
Record the date (and time) the medical condition/disease stopped. For surgeries, start and stop dates will most likely be the same date. 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 | 3.10 | 2024-02-29 15:42:44.0 | Medical History | General Health History | Participant History and Family History |
Free-Form Entry |
3145557 | |||||||||
| C00317 | Medical history condition start date and time | MedclHistCondStrtDateTime | Date (and time, if applicable and known) for the start of an event in the participant's medical history | Date (and time, if applicable and known) for the start of an event in the participant's medical history | Start Date | Date or Date & Time |
Record the date (and time) the medical condition/disease started. At a minimum the start year (YYYY) should be recorded. 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 | 3.10 | 2024-02-29 15:42:43.0 | Medical History | General Health History | Participant History and Family History |
Free-Form Entry |
2543596 | |||||||||
| C00319 | Medical history condition ongoing indicator | MedclHistCondOngoingInd | Indicator of whether a medical condition/disease experienced by the participant is ongoing | Indicator of whether a medical condition/disease experienced by the participant is ongoing | Ongoing? | Yes;No | Yes;No | Alphanumeric |
Check Yes or No to indicate if the medical condition/disease is still present. |
No references available | Adult;Pediatric | Supplemental | 4.00 | 2024-02-29 15:42:44.0 | Medical History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
2736881 | |||||||
| C00322 | Medical history condition text | MedclHistCondTxt | Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history | Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history | Description | Alphanumeric |
Record one Medical History term per line. Document the specific diagnosis for each pre-existing neuro-musculoskeletal condition and document the location/anatomic site if not obvious. Previous surgeries due to any of the conditions should also be documented with this element. Record each condition or surgery on separate lines. Make sure to record if the following events are in the medical history which are Core items: Any stroke; Ischemic stroke; Hemorrhagic stroke; Hemorrhagic stroke type; 4) Transient ischemic attack (TIA); Carotid stenosis; Epilepsy/ Seizure disorder; Central nervous system infection; Dementia; Head trauma; Head trauma type; Atrial fibrillation (AF)/ flutter; Rheumatic heart disease |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Medical History | General Health History | Participant History and Family History | 4000 |
Free-Form Entry |
2003874 | ||||||||
| C18666 | Body system category other text | BodySysCatOTH | The free-text field related to 'Body system category', specifying other text. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured | The free-text field related to 'Body system category', specifying other text. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured | Other, specify | Alphanumeric |
Record the appropriate body system for each line of medical history. Choose one. Response is obtained by report of the participant/subject or proxy as soon as possible after visit/admission. Document the date the history was obtained so it can be determined whether this information was obtained prior to study enrollment or later. For TBI: Recommend collection at least on date of TBI or at time of first medical treatment. Comorbidity prior to injury may influence the disease course and chances of recovery. Serious comorbidity or comorbidity that may influence the assessment of outcome are generally considered exclusion criteria in randomized clinical trials. It is therefore highly relevant to accurately record the significant relevant medical history. For SCI: Record all pulmonary conditions present before spinal cord lesion. For ALS: Each body system is pre-populated on the case report form. Record the physical exam results for each. The 'Neurological' body system should only be used to record physical examination findings separate from the ALS exam. |
Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf. Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Bauman WA, Biering-SØrensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. | Adult;Pediatric | Supplemental | 1.10 | 2023-11-07 08:40:35.0 | Medical History | General Health History | Participant History and Family History | 4000 |
Free-Form Entry |
2002895 | ||||||||
| 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 |
Answer should be recorded in weeks |
Stroke Reference: Govaert P, Ramenghi L, Taal R, de Vries L, Deveber G. Diagnosis of perinatal stroke I: definitions, differential diagnosis and registration. Acta Paediatr. 2009 Oct;98(10):1556-67. | Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Medical History | General Health History | Participant History and Family History |
Free-Form Entry |
0 | 52 | week | 3192017 | ||||||
| C00312 | Body system category | BodySysCat | Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems | Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body system | Body System | Constitutional symptoms (e.g., fever, weight loss);Eyes;Ears, Nose, Mouth, Throat;Cardiovascular;Respiratory;Gastrointestinal;Genitourinary;Hepatobiliary;Musculoskeletal;Integumentary (skin and/or breast);Neurological;Psychiatric;Endocrine;Hematologic/Lymphatic;Allergic/Immunologic | Constitutional symptoms (e.g., fever, weight loss);Eyes;Ears, Nose, Mouth, Throat;Cardiovascular;Respiratory;Gastrointestinal;Genitourinary;Hepatobiliary;Musculoskeletal;Integumentary (skin and/or breast);Neurological;Psychiatric;Endocrine;Hematologic/Lymphatic;Allergic/Immunologic | Alphanumeric |
Core for Multiple Sclerosis studies Record the appropriate body system for each line of medical history. Choose one. Response is obtained by report of the participant/subject or proxy as soon as possible after visit/admission. Document the date the history was obtained so it can be determined whether this information was obtained prior to study enrollment or later. For TBI: Recommend collection at least on date of TBI or at time of first medical treatment. Comorbidity prior to injury may influence the disease course and chances of recovery. Serious comorbidity or comorbidity that may influence the assessment of outcome are generally considered exclusion criteria in randomized clinical trials. It is therefore highly relevant to accurately record the significant relevant medical history. For SCI: Record all pulmonary conditions present before spinal cord lesion. For ALS: Each body system is pre-populated on the case report form. Record the physical exam results for each. The 'Neurological' body system should only be used to record physical examination findings separate from the ALS exam. |
Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf. Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Bauman WA, Biering-SØrensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Medical History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
2002895 |
