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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: Laboratory Tests and Biospecimens/Biomarkers
CRF: Laboratory Tests and Tracking
Item count: 18 (18 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
C01703
Lab panel category
LabPanelCat
Category or panel of lab tests, often logically grouped according to type of testing (Hematology, Chemistry, Urinalysis) or specimen type (Blood, Urine, CSF)
Lab Panel
Chemistry;Hematology;Urinalysis;Other, specify;
Chemistry;Hematology;Urinalysis;Other, specify;
Alphanumeric
Choose the lab panel that was performed
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Lab panel category
 
Single Pre-Defined Value Selected
     
3158057
 
C18729
Lab panel other text
LabPanelOTH
The free-text field related to 'Lab panel category' specifying other text. Category or panel of lab tests, often logically grouped according to type of testing (Hematology, Chemistry, Urinalysis) or specimen type (Blood, Urine, CSF)
Other, specify
  
Alphanumeric
Choose the lab panel that was performed
No references available
Adult;Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
 
4000
Free-Form Entry
     
3158057
 
C01701
Lab specimen collection date and time
LabSpecmnCollDateTime
Date (and time if applicable and known) when the specimen was collected
Date Collected
  
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
Core
3.0
7/25/2013
Aliases for variable name not defined
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Lab specimen collection date and time
 
Free-Form Entry
     
2004004
 
C01700
Specimen accession number
SpecmnAcssnNum
Number with which the specimen taken for the tests being reported was accessioned to the record storage facility
Accession Number
  
Numeric Values
Provide the accession number or bar code number that is assigned to the specimen.
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
SPEC_ACCNUM
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Specimen accession number
 
Free-Form Entry
     
2230047
 
C01705
Lab test name
LabTestName
Name representing the lab test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions.
Test Name
Glucose;Fasting Glucose;Fasting Insulin;Urea;Creatinine;Amylase;Aspartate Aminotransferase (AST/ASAT/SGOT);Alanine Aminotransferase (ALT/ALAT/SGPT);Gamma-glutamyl transpeptidase (GGT);Lactate Dehydrogenase (LDH);Alkaline Phosphatase;Total Bilirubin;Sodium (Na);Potassium (K);Hemoglobin (HB);Hematocrit (HCT);Urine White Blood Cells (WBC);Glycosylated Hemoglobin;Neutrophil Count;Lymphocyte Count;Monocyte Count;Eosinophil Count;Platelet Count;Prothrombin Time (PT);Iron;Total Iron Binding Capacity(TIBC);Ferritin;Magnesium (Mg);Phosphate (PO4);Calcium (Ca);Ionized Calcium;Bicarbonate (HCO3);International Normalized Ratio (INR);Chloride (Cl);Carbon Dioxide (CO2);Anion Gap;Blood Urea Nitrogen (BUN);Vitamin B12;Total Cholesterol (TCHOL);Low Density Lipoprotein (LDL);High Density Lipoprotein (HDL);Triglycerides (TGs);Very Low Density Lipoprotein (VLDL);Lipoprotein (a) [Lp(a)];Apolipoprotein-I (apo A1);Apolipoprotein B (apo B);apolipoprotein E (apo E);C-Reactive Protein;Frataxin Level;GAA repeat-expansion mutation;Serum N-terminal atrial natriuretic peptide (ANP-N);B-type natriuretic peptide (BNP);Oral glucose tolerance;Vitamin E;Lactate;Troponin I;Troponin T;Creatine Kinase;Creatine Kinase-Myocardial Bands (CK-MB);Hemoglobin Electrophoresis;Urine pH;Urine Nitrite;Urine Creatinine;Urine 8-OH-2-deoxyguanosine/creatinine ratio;8-OH-2-deoxyguanosine;8-isoprostanes;Plasma malondialdehyde;Other, specify;
Glucose;Fasting Glucose;Fasting Insulin;Urea;Creatinine;Amylase;Aspartate Aminotransferase (AST/ASAT/SGOT);Alanine Aminotransferase (ALT/ALAT/SGPT);Gamma-glutamyl transpeptidase (GGT);Lactate Dehydrogenase (LDH);Alkaline Phosphatase;Total Bilirubin;Sodium (Na);Potassium (K);Hemoglobin (HB);Hematocrit (HCT);Urine White Blood Cells (WBC);Glycosylated Hemoglobin (HgBA1C);Neutrophil Count;Lymphocyte Count;Monocyte Count;Eosinophil Count;Platelet Count;Prothrombin Time (PT);Iron;Total Iron Binding Capacity(TIBC);Ferritin;Magnesium (Mg);Phosphate (PO4);Calcium (Ca);Ionized Calcium;Bicarbonate (HCO3);International Normalized Ratio (INR);Chloride (Cl);Carbon Dioxide (CO2);Anion Gap;Blood Urea Nitrogen (BUN);Vitamin B12;Total Cholesterol (TCHOL);Low Density Lipoprotein (LDL);High Density Lipoprotein (HDL);Triglycerides (TGs);Very Low Density Lipoprotein (VLDL);Lipoprotein (a) [Lp(a)];Apolipoprotein-I (apo A1);Apolipoprotein B (apo B);apolipoprotein E (apo E);C-Reactive Protein;Frataxin Level;GAA repeat-expansion mutation;Serum N-terminal atrial natriuretic peptide (ANP-N);B-type natriuretic peptide (BNP);Oral glucose tolerance;Vitamin E;Lactate;Troponin I;Troponin T;Creatine Kinase;Creatine Kinase-Myocardial Bands (CK-MB);Hemoglobin Electrophoresis;Urine pH;Urine Nitrite;Urine Creatinine;Urine 8-OH-2-deoxyguanosine/creatinine ratio;8-OH-2-deoxyguanosine;8-isoprostanes;Plasma malondialdehyde;Other, specify;
Alphanumeric
Indicate the name of each laboratory test that is run on the specimen. See the data dictionary for additional information on coding the test name using Logical Observation Identifiers Names and Codes (LOINC).
Logical Observation Identifiers Names and Codes (LOINC) - https://loinc.org/
Adult;Pediatric
Core
3.0
7/25/2013
Refer to SCI CDE Annotated Form
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Lab test name
 
Single Pre-Defined Value Selected
     
2003746
 
C18731
Lab test other text
LabTestOTH
The free-text field related to 'Lab test name' specifying other text. Name representing the lab test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested and any special instructions.
Other, specify
  
Alphanumeric
Indicate the name of each laboratory test that is run on the specimen. See the data dictionary for additional information on coding the test name using Logical Observation Identifiers Names and Codes (LOINC).
Logical Observation Identifiers Names and Codes (LOINC) - https://loinc.org/
Adult;Pediatric
Core
1.0
5/27/2014
Aliases for variable name not defined
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
 
4000
Free-Form Entry
     
2003746
 
C01720
Lab test LOINC code
LabTestLOINCCode
Identifier name given to a test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions.
Test Name
  
Alphanumeric
Indicate the name of each laboratory test that is run on the specimen. See the data dictionary for additional information on coding the test name using Logical Observation Identifiers Names and Codes (LOINC).
Logical Observation Identifiers Names and Codes (LOINC) - https://loinc.org/
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Lab test LOINC code
 
Free-Form Entry
       
C01708
Lab test performed indicator
LabTestPerfInd
Indicator of whether the lab test has been performed on the participant/subject
Test Performed?
Yes;No;
Yes;No;
Alphanumeric
Choose one. Indicate if any laboratory test results were reported for the specimen.
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
LAB_RSL_RPT_STATUS
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Lab test performed indicator
 
Single Pre-Defined Value Selected
     
3158111
 
C01706
Lab test result text
LabTestResltTxt
Result of the laboratory test
Result
  
Alphanumeric
Record the numeric or alpha-numeric results for each laboratory test.
No references available
Adult;Pediatric
Core
3.0
7/25/2013
Refer to SCI CDE Annotated Form
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Lab test result
4000
Free-Form Entry
     
2183364
 
C01711
Lab test result unit of measure
LabTestResltUoM
Unit of measure for the laboratory test result
Units for Result
  
Alphanumeric
Record the units the numeric results for each laboratory test are measured in. See the data dictionary for additional information on coding the unit of measure using Unified Code for Units of Measure (UCUM).
Unified Code for Units of Measure - http://unitsofmeasure.org/
Adult;Pediatric
Core
3.0
7/25/2013
Refer to SCI CDE Annotated Form
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Lab test result unit of measure
255
Free-Form Entry
     
2787947
 
C01713
Lab test result unit of measure UCUM code
LabTestResltUoMUCUMCode
Unified Code for Units of Measure (UCUM) unit code for the result of the lab test being performed on the specimen
   
Alphanumeric
Record the units the numeric results for each laboratory test are measured in. See the data dictionary for additional information on coding the unit of measure using Unified Code for Units of Measure (UCUM).
Unified Code for Units of Measure - http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
3.0
7/25/2013
Refer to SCI CDE Annotated Form
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Lab test result unit of measure UCUM code
255
Free-Form Entry
       
C01709
Lab test result status
LabTestResltStatus
Status of the laboratory test result, usually based upon the comparison of the test result to the normal range for the lab test performed
Was test result abnormal?
Normal;Abnormal;Unknown;
Normal;Abnormal;Unknown;
Alphanumeric
Choose one. Indicate if the laboratory test result is abnormal. Abnormal means the test result falls outside the normal range.
No references available
Adult;Pediatric
Core
3.0
7/25/2013
Aliases for variable name not defined
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Lab test result status
 
Single Pre-Defined Value Selected
     
2841229v1
 
C01707
Lab test abnormality significance type
LabTestAbnrmlySignfcnceTyp
Indicator as to whether or not the abnormal lab result for the associated test was considered clinically significant for the participant/subject.
If abnormal, clinically significant?
Clinically Significant;Not Clinically Significant;
Clinically Significant;Not Clinically Significant;
Alphanumeric
Choose one. If the laboratory test result is abnormal, indicate if the physician considers the result clinically significant.
No references available
Adult;Pediatric
Core
3.0
7/25/2013
Aliases for variable name not defined
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Lab test abnormality significance type
 
Single Pre-Defined Value Selected
     
3179449
 
C10896
Pregnancy test performed indicator
PregTestPerfInd
Indicator as to whether or not a pregnancy test was performed on the participant/subject
Was a pregnancy test performed?
Yes;No;Unknown;
Yes;No;Not applicable;
Alphanumeric
If no, stop.
No references available
Adult;Pediatric
Core
3.0
7/25/2013
Aliases for variable name not defined
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Pregnancy test performed indicator
 
Single Pre-Defined Value Selected
       
C01714
Pregnancy test not applicable reason
PregTestNotApplcblRsn
Reason that performance of a pregnancy test was not applicable to the participant/subject
Pregnancy test: Reason Test N/A
Post-Menopausal;Surgically sterile;Non-surgically sterile;Male;
Post-Menopausal;Surgically sterile;Non-surgically sterile;Male;
Alphanumeric
Choose one
No references available
Adult;Pediatric
Core
3.0
7/25/2013
Aliases for variable name not defined
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Pregnancy test not applicable reason
 
Single Pre-Defined Value Selected
       
C01702
Pregnancy test date and time
PregTestDateTime
The date (and time if applicable and known) when the pregnancy test was performed
Date Performed
  
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
Core
3.0
7/25/2013
Aliases for variable name not defined
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Pregnancy test date and time
 
Free-Form Entry
       
C01704
Pregnancy test specimen type
PregTestSpecmnTyp
Type of specimen collected to perform the pregnancy test
Pregnancy Test Type
Blood;Urine;
Blood;Urine;
Alphanumeric
Choose one
No references available
Adult;Pediatric
Core
3.0
7/24/2013
Aliases for variable name not defined
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Pregnancy test specimen type
 
Single Pre-Defined Value Selected
       
C01710
Pregnancy test qualitative result value
PregTestQualResltVal
Result of the pregnancy test
Pregnancy test qualitative result
Positive;Negative;
Positive;Negative;
Alphanumeric
Choose one
No references available
Adult;Pediatric
Core
3.0
7/25/2013
Aliases for variable name not defined
Laboratory Tests and Tracking
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Pregnancy test qualitative result
 
Single Pre-Defined Value Selected
       
12-17-2018
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