CDE Detailed Report
Disease: Spinal Muscular Atrophy
Subdomain Name: Laboratory Tests and Biospecimens/Biomarkers
CRF: Laboratory Tests and Tracking
Displaying 1 - 18 of 18
Subdomain Name: Laboratory Tests and Biospecimens/Biomarkers
CRF: Laboratory Tests and Tracking
Displaying 1 - 18 of 18
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Core | 3.00 | 2013-07-24 11:38:01.2 | Laboratory Tests and Tracking | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
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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 |
If no, stop. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests and Tracking | 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 Name | 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;Urine White Blood Cells (WBC);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);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;Urine White Blood Cells (WBC);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);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 | 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 | 4.00 | 2024-03-18 15:21:17.0 | Laboratory Tests and Tracking | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
2003746 | |||||||
| 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 |
Choose the lab panel that was performed |
No references available | Adult;Pediatric | Supplemental | 1.00 | 2014-05-27 13:34:46.0 | Laboratory Tests and Tracking | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations | 4000 |
Free-Form Entry |
3158057 | ||||||||
| C01706 | Lab test result text | LabTestResltTxt | Result of the laboratory test | Result of the laboratory test | Result | Alphanumeric |
Record the numeric or alpha-numeric results for each laboratory test. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests and Tracking | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations | 4000 |
Free-Form Entry |
2183364 | ||||||||
| 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. 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 | 1.00 | 2014-05-27 13:34:46.0 | Laboratory Tests and Tracking | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations | 4000 |
Free-Form Entry |
2003746 | ||||||||
| 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 and Tracking | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
3179449 | |||||||
| 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 and Tracking | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
3158111 | |||||||
| 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 and Tracking | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
2841229v1 | |||||||
| 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 | Core | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests and Tracking | 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 | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests and Tracking | 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 | 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 | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests and Tracking | 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 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 | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests and Tracking | 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 |
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 | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests and Tracking | 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.). |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests and Tracking | 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 |
Choose one |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests and Tracking | 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 |
Choose the lab panel that was performed |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests and Tracking | 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 | 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 | 3.00 | 2013-07-25 08:54:08.2 | Laboratory Tests and Tracking | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations | 7 |
Free-Form Entry |
