of0
Export
 
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: General (For all diseases)
Sub-Domain: General Health History
CRF: Medical History
Item count: 15 (15 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
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
Record the date (and time) the medical history was taken. 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
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
 
C00315
Medical history global assessment indicator
MedclHistGlobalAssmtInd
Indicator of whether the participant/subject 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;Unknown;
Yes;No;Unknown;
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
3.0
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
 
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
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
Record the appropriate body system for each line of medical history.
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
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
Record the appropriate body system for each line of medical history.
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
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
 
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 History Term
  
Alphanumeric
Record one Medical History term per line. See the data dictionary for additional information on coding the condition 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
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
 
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
Medical History Term
  
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
       
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 themedical condition/disease started. 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
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
 
C00319
Medical history condition ongoing indicator
MedclHistCondOngoingInd
Indicator of whether a medical condition/disease experienced by the participant/subject is ongoing
Ongoing?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Check Yes or No to indicate if the medical condition/disease is still present.
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
Medical history condition ongoing indicator
 
Single Pre-Defined Value Selected
     
2736881
 
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
If the condition is not ongoing, record the date (and time) the medical condition/disease stopped. 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
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
 
C00311
Birth weight value
BirthWgtVal
Birth weight according to the participant's/subject's medical report or reported by the parent or legal guardian
Birth Weight
  
Numeric Values
Record the birth weight of the participant/subject. This element is intended for pediatric clinical studies.
No references available
Pediatric
Supplemental
3.0
7/24/2013
PERS_MEAS_BIR_WT_VAL
Medical History
General Health History
Participant History and Family History
Birth weight value
 
Free-Form Entry
0
9000
gram
  
3201400;2179689
 
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.
Gestational Age
  
Numeric Values
Record the gestational age of the participant/subject in weeks and days. This element is intended for pediatric clinical studies.
No references available
Pediatric
Supplemental
3.0
7/25/2013
GESTA_NAT_AGE
Medical History
General Health History
Participant History and Family History
Gestational age value
 
Free-Form Entry
0
52
week
  
3192017
 
C00003
Postnatal age value
PostnatalAgeVal
Time elapsed after birth of the participant/subject
Post Natal Age (PNA)
  
Numeric Values
Record the post natal age of the participant/subject in weeks and days. This element is intended for pediatric clinical studies.
No references available
Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Postnatal age value
 
Free-Form Entry
  
day
  
3182608
 
C00002
Post conceptional age value
PostConceptnAgeVal
Gestational age plus postnatal age of the participant/subject
Post Conceptional Age (PCA)
  
Numeric Values
Record the post conceptional age of the participant/subject in weeks and days. This element is intended for pediatric clinical studies. This field is not needed if Gestational Age and Post Natal Age are captured since it can be derived from those data.
No references available
Pediatric
Supplemental
3.0
7/24/2013
POST_CONCEPT_AGE
Medical History
General Health History
Participant History and Family History
Post conceptional age value
 
Free-Form Entry
  
day
  
3182713
 
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.
5 minute APGAR 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
3.0
7/25/2013
APGAR_SC_FV_MIN_NUM
Medical History
General Health History
Participant History and Family History
APGAR five minute score
 
Single Pre-Defined Value Selected
     
2738533
 
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.
10 minute APGAR 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
3.0
7/25/2013
APGAR_SC_TN_MIN_NUM
Medical History
General Health History
Participant History and Family History
APGAR ten minute score
 
Single Pre-Defined Value Selected
     
3181701
 
12-09-2018
Page 1 of 1