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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease:
Sub-Domain: General Health History
CRF: Medical History
Item count: 19 (19 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C00315
Medical history global assessment indicator
MedclHistGlobalAssmtInd
Indicator of whether the participant/subject has a history of any medical problems/conditions
 
Yes;No;
Yes;No;
Alphanumeric
Supplemental - Highly Recommended
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/25/2013
MED_HIST_YN
Medical History
General Health History
Participant History and Family History
Medical history global assessment indicator
 
Single Pre-Defined Value Selected
     
3145578
 
C00314
Medical history taken date and time
MedclHistTakenDateTime
Date (and time, if applicable and known) the participant/subject's medical history was taken
Date Medical History Taken:
  
Date or Date & Time
Supplemental - Highly Recommended
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
3.0
7/25/2013
PT_REL_MED_HIST_DT
Medical History
General Health History
Participant History and Family History
Medical history taken date and time
 
Free-Form Entry
     
2179659
 
C08007
Diagnosis first given date and time
DiagnosFirstGivnDateTime
Date (and time if applicable and known) the participant/subject was initially diagnosed with the disease or disorder
Date at diagnosis
  
Date or Date & Time
No instructions available
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/24/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Diagnosis first given date and time
 
Free-Form Entry
       
C10501
Diagnosis initial age value
DiagnosAgeVal
Age of the participant/subject when initially diagnosed with disease/disorder
Age at diagnosis
  
Numeric Values
Answer should be recorded in years. History can be obtained from participant/ subject, family member, friend, or chart/ medical record.
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Diagnosis age value
 
Free-Form Entry
  
year
    
C18241
Diagnosis age type
DiagnosAgeTyp
Type of age of the participant/subject when initially diagnosed with disease/disorder
Age at diagnosis
years;Months;Weeks;Days;Hours;
years;Months;Weeks;Days;Hours;
Alphanumeric
Choose only one
No references available
Adult;Pediatric
Supplemental
3.0
7/21/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C08006
Symptoms first appeared date and time
SymptmFirstAppearDateTime
Date (and time if applicable and known) the symptoms for the disease or disorder first appeared as confirmed by the participant's/subject's medical history obtained by a physician
Date of first symptom
  
Date or Date & Time
No instructions available
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/24/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Symptoms first appeared date and time
 
Free-Form Entry
       
C18242
Symptoms first appeared age value
SymptmFrstApprAgVal
Value of the age at which the participant/subject first noted a neuromuscular symptom
Age at first symptom
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/21/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Free-Form Entry
       
C18243
Symptom first appear age type
SymptmFrstApprAgTyp
Type of age of the participant/subject at first symptom appearance
Age at first symptom
years;Months;Weeks;Days;Hours;
years;Months;Weeks;Days;Hours;
Alphanumeric
Choose only one
No references available
Adult;Pediatric
Supplemental
3.0
7/21/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C18253
Clinical trial previous participation indicator
ClinTrialPrevPrtpInd
Indicator of whether the participant/subject participated in any prior clinical trials
Has participant participated in prior clinical trials?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Supplemental - Highly Recommended
Choose one
No references available
Adult;Pediatric
Supplemental
3.0
7/21/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
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
Medical Condition
  
Alphanumeric
Supplemental - Highly Recommended
SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html)
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/25/2013
Refer to SCI CDE Annotated Form
Medical History
General Health History
Participant History and Family History
Medical history condition text
4000
Free-Form Entry
     
2003874
 
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/subject's medical history
Start Date
  
Date or Date & Time
Record the date the medical condition/disease started. 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.) and in the format acceptable to the study database.
Supplemental - Highly Recommended
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/25/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Medical history condition start date and time
 
Free-Form Entry
     
2543596
 
C18246
Medical history condition start age value
MedHistCondStrtAgeVal
Value of the age, approximated, when the specific medical condition began
Start Date or Age (approximate)
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/21/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Free-Form Entry
       
C00319
Medical history condition ongoing indicator
MedclHistCondOngoingInd
Indicator of whether a medical condition/disease experienced by the participant/subject is ongoing
Continuing?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Supplemental - Highly Recommended
Check Yes or No to indicate if the medical condition/disease is still present.
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/24/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Medical history condition ongoing indicator
 
Single Pre-Defined Value Selected
     
2736881
 
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
SNOMED CT code
  
Alphanumeric
Code each of the medical history conditions using SNOMED CT
SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html)
Adult;Pediatric
Core
3.0
7/25/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Medical history condition SNOMED CT code
255
Free-Form Entry
       
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/subject's medical history
End Date
  
Date or Date & Time
Supplemental - Highly Recommended
Recordthe date the medical condition/disease ended. 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.) and in the format acceptable to the study database.
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/25/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Medical history condition end date and time
 
Free-Form Entry
     
3145557
 
C18256
Medical history condition end age value
MedHistCondEndAgeVal
Value of the age, approximated, when the specific medical condition ended
If no, indicate End Date or Age (approximate)
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/21/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Free-Form Entry
       
C18254
Medical history assessment indicator
MedclHistAssmtInd
Whether the participant/subject has a history of any medical problems/conditions
History of any medical problems or conditions?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Supplemental - Highly Recommended
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/21/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
     
3145578
 
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.
Body system category
Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify:;
Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify:;
Alphanumeric
Supplemental - Highly Recommended
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
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/25/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Body system category
 
Single Pre-Defined Value Selected
     
2002895
 
C18666
Body system other text
BodySysOTH
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
Supplemental - Highly Recommended
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
Adult;Pediatric
Supplemental–Highly Recommended
1.0
5/27/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
 
4000
Free-Form Entry
     
2002895
 
07-15-2019
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