CDE Detailed Report
Subdomain Name: Laboratory Tests and Biospecimens/Biomarkers
CRF: Laboratory Tests
Displaying 1 - 26 of 26
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 |
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C58709 | Lab test abnormality result too high too low indicator | LabTstAbnmlRsltTooHghTooLowInd | Indication of lab panel test result, either too high or too low | Indication of lab panel test result, either too high or too low | Indicate lab test abnormaility by specifying if result is too high or too low | Too high;Too low | Too high;Too low | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2020-05-05 16:24:02.0 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
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C58710 | Frataxin level status | FrataxinLevelStat | Level of frataxin | Level of frataxin | Frataxin level | Alphanumeric |
For FXN, ApoA1, insulin / blood glucose, and cardiac troponin. Record what tissue was collected, how that tissue was processed (e.g. whole blood vs. platelet), and what assays were used with details (e.g. which antibodies were used). |
Adult;Pediatric | Core | 1.00 | 2020-05-05 16:27:46.0 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations | 255 |
Free-Form Entry |
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C58711 | GAA repeat expansion mutation size text | GaaRptExpanMutatSizeTxt | Text field for identifying the GAA repeat-expansion mutation | Text field for identifying the GAA repeat-expansion mutation | GAA repeat-expansion mutation | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2020-05-05 16:36:16.0 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations | 255 |
Free-Form Entry |
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C58712 | Lab test method used type | LabTestMethodUsedTyp | Text field identifying the lab test method used | Text field identifying the lab test method used | Specify method used | Alphanumeric | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2020-05-05 16:37:59.0 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations | 255 |
Free-Form Entry |
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C58713 | Lab test sample type text | LabTestSamplTypTxt | Text field for identifying the type of sample collected | Text field for identifying the type of sample collected | Specify type of sample | Alphanumeric | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2020-05-05 16:40:03.0 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations | 255 |
Free-Form Entry |
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C10896 | Pregnancy test performed indicator | PregTestPerfInd | Indicator as to whether or not a pregnancy test was performed on the participant/subject | Indicator as to whether or not a pregnancy test was performed on the participant/subject | Was a pregnancy test performed? | Alphanumeric |
Choose one |
No references available | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
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C01706 | Lab test result text | LabTestResltTxt | Result of the laboratory test | Result of the laboratory test | Result | Alphanumeric |
Record the numeric results or alpha-numeric results for each laboratory test. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations | 4000 |
Free-Form Entry |
2183364 | ||||||||
C17503 | Hemoglobin electrophoresis type | HemoglbnElectrophoresisType | Type of hemoglobin that was identified by the electrophoresis test being reported | Type of hemoglobin that was identified by the electrophoresis test being reported | Hemoglobin electrophoresis result | HbSS;HbSA;HBAA;HbFF;HbAF | HbSS;HbSA;HBAA;HbFF;HbAF | Alphanumeric | No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-15 16:08:48.687 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
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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 | Indicator as to whether or not the abnormal lab result for the associated test was considered clinically significant for the participant/subjec | 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 | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
3179449 | |||||||
C17505 | Urine nitrite result | UrineNitriteReslt | Result of the urine nitrite test being reported | Result of the urine nitrite test being reported | Urine Nitrite result | Positive;Negative | Positive;Negative | Alphanumeric | No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-15 16:08:48.687 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
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C01708 | Lab test performed indicator | LabTestPerfInd | Indicator of whether the lab test has been performed on the participant/subject | 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 | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
3158111 | |||||||
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) | 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 |
Check all that apply. |
No references available | Adult;Pediatric | Supplemental | 1.00 | 2014-05-27 13:34:46.0 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations | 4000 |
Free-Form Entry |
3158057 | ||||||||
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 | 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? | Abnormal;Normal;Unknown | Abnormal;Normal;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 | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
2841229v1 | |||||||
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 | 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 instruction | Other, specify | Alphanumeric |
Indicate the name of each laboratory test that is run on the specimen. |
No references available | Adult;Pediatric | Core | 1.00 | 2014-05-27 13:34:46.0 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations | 4000 |
Free-Form Entry |
2003746 | ||||||||
C01710 | Pregnancy test qualitative result value | PregTestQualResltVal | Result of the pregnancy test | Result of the pregnancy test | Pregnancy test qualitative result | Positive;Negative | Positive;Negative | Alphanumeric |
Choose one |
No references available | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
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C01700 | Specimen accession number | SpecmnAcssnNum | Number with which the specimen taken for the tests being reported was accessioned to the record storage facility | 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 | Core | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Free-Form Entry |
2230047 | |||||||||
C01711 | Lab test result unit of measure | LabTestResltUoM | Unit of measure for the laboratory test result | Unit of measure for the laboratory test result | Unit for Result | Alphanumeric |
Record the units the numeric results for each laboratory test are measured in. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations | 255 |
Free-Form Entry |
2787947 | ||||||||
C01701 | Lab specimen collection date and time | LabSpecmnCollDateTime | Date (and time if applicable and known) when the specimen was collected | Date (and time if applicable and known) when the specimen was collected | Date and Time 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). Record the date (and time) the specimen was collected. The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete data plus hours and minutes, etc) and in the format acceptable to the study database. mm/dd/yyyy and 24-hr clock. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Free-Form Entry |
2004004 | |||||||||
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 | Unified Code for Units of Measure (UCUM) unit code for the result of the lab test being performed on the specimen | Alphanumeric | Unified Code for Units of Measure - http://unitsofmeasure.org/ | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations | 255 |
Free-Form Entry |
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C01702 | Pregnancy test date and time | PregTestDateTime | The date (and time if applicable and known) when the pregnancy test was performed | 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.). mm/dd/yyyy |
No references available | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Free-Form Entry |
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C01714 | Pregnancy test not applicable reason | PregTestNotApplcblRsn | Reason that performance of a pregnancy test was not applicable to the participant/subject | 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 | No references available | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
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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) | 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 |
Check all that apply. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
3158057 | |||||||
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 | 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 instruction | Alphanumeric | Logical Observation Identifiers Names and Codes (LOINC) - https://loinc.org/ | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations | 7 |
Free-Form Entry |
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C01704 | Pregnancy test specimen type | PregTestSpecmnTyp | Type of specimen collected to perform the pregnancy test | Type of specimen collected to perform the pregnancy test | Pregnancy Test Type | Blood;Urine | Blood;Urine | Alphanumeric |
Choose one |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-24 11:38:01.2 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
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C10564 | Lab blood specimen fast prior indicator | LabBloodSpecimenFastPriorInd | Indicator of whether the participant was fasting prior to collection of blood lab specimen | Indicator of whether the participant was fasting prior to collection of blood lab specimen | Did the participant/ subject fast prior to laboratory testing? | Yes;No | Yes;No | Alphanumeric |
Choose one |
No references available | Adult;Pediatric | Supplemental | 4.00 | 2024-03-11 10:03:15.0 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
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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 | 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 | White Blood Cell Count (WBC);Lymphocyte Count;Neutrophil Count;Monocyte Count;Eosinophil Count;Hematocrit (HCT);Hemoglobin (HB);Glycosylated Hemoglobin (HgBA1C);Platelet Count;Vitamin B12;Sodium (Na);Potassium (K);Chloride (Cl);Carbon Dioxide (CO2);Anion Gap;Blood Urea Nitrogen (BUN);Creatinine;Glucose;Fasting Glucose;Fasting Insulin;Iron;Total Iron Binding Capacity(TIBC);Ferritin;Magnesium (Mg);Phosphate (PO4);Calcium (Ca);Ionized Calcium;Bicarbonate (HCO3);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);Atrial natriuretic peptide (ANP);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;Alanine Aminotransferase (ALT/ALAT/SGPT);Aspartate Aminotransferase (AST/ASAT/SGOT);Gamma-glutamyl transpeptidase (GGT);Urine White Blood Cells (WBC);Urine pH;Urine Nitrite;Urine Creatinine;8-OH-2-deoxyguanosine;Urine 8-OH-2-deoxyguanosine/creatinine ratio;8-isoprostanes;Plasma malondialdehyde | White Blood Cell Count (WBC);Lymphocyte Count;Neutrophil Count;Monocyte Count;Eosinophil Count;Hematocrit (HCT);Hemoglobin (HB);Glycosylated Hemoglobin (HgBA1C);Platelet Count;Vitamin B12;Sodium (Na);Potassium (K);Chloride (Cl);Carbon Dioxide (CO2);Anion Gap;Blood Urea Nitrogen (BUN);Creatinine;Glucose;Fasting Glucose;Fasting Insulin;Iron;Total Iron Binding Capacity(TIBC);Ferritin;Magnesium (Mg);Phosphate (PO4);Calcium (Ca);Ionized Calcium;Bicarbonate (HCO3);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);Atrial natriuretic peptide (ANP);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;Alanine Aminotransferase (ALT/ALAT/SGPT);Aspartate Aminotransferase (AST/ASAT/SGOT);Gamma-glutamyl transpeptidase (GGT);Urine White Blood Cells (WBC);Urine pH;Urine Nitrite;Urine Creatinine;8-OH-2-deoxyguanosine;Urine 8-OH-2-deoxyguanosine/creatinine ratio;8-isoprostanes;Plasma malondialdehyde | Alphanumeric |
Indicate the name of each laboratory test that is run on the specimen. For FXN, ApoA1, insulin / blood glucose, and cardiac troponin. Record what tissue was collected, how that tissue was processed (e.g. whole blood vs. platelet), and what assays were used with details (e.g. which antibodies were used). Core tests: Red Blood Cell Count (RBC), White Blood Cell Count (WBC), Lymphocyte Count, Neutrophil Count, Monocyte Count, Eosinophil Count, Hematocrit (HCT), Hemoglobin (HB), Platelet Count, Glucose, Fasting Glucose, Glycosylated Hemoglobin (HgBA1C), Blood Urea Nitrogen (BUN), Creatinine, Sodium (Na), Potassium (K), Chloride (Cl), Carbon Dioxide (CO2), Anion Gap, Alanine Aminotransferase (ALT/ALAT/SGPT), Aspartate aminotransferase (AST/ASAT/SGOT), Gamma-glutamyl transpeptidase (GGT), C-Reactive Protein, Urinalysis test strip Supplemental-Highly Recommended Tests: Iron, Calcium (Ca), Phosphate (PO4), Magnesium (Mg), Total Iron Binding Capacity (TIBC), Ferritin Supplemental Tests: Fasting insulin, Oral glucose tolerance, Lactate, Ionized Calcium, Bicarbonate (HCO3), Total Cholesterol (TCHOL), Very Low Density Lipoprotein (VLDL), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides (TGs), Urine White Blood Cells, Urine pH, Urine glucose, Urine creatinine, Urine nitrite, Urine culture Exploratory: Apolipoprotein-I (apo A1) |
No references available | Adult;Pediatric | Core | 4.00 | 2024-03-18 15:21:17.0 | Laboratory Tests | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
2003746 |