CDE Detailed Report

Disease: Facioscapulohumeral Muscular Dystrophy
Subdomain Name: Laboratory Tests and Biospecimens/Biomarkers
CRF: Laboratory Tests and Tracking

Displaying 1 - 17 of 17
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
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 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

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

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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 Supplemental 3.00 2013-07-25 08:54:08.2 Laboratory Tests and Tracking Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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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 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

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 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

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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 and Tracking Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

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 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

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);Atrial natriuretic peptide (ANP);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);White Blood Cell Count (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;Glucose;Albumin;Total protein;Pre-Albumin;Phenytoin (Dilantin);Glucose D-stick;Glucose serum;Serum OSM;Partial Thromboplastin Time (PTT);Phenobarb;Cortisol;Direct bilirubin;Activated Partial Thromboplastin Time (aPTT);Fibrinogen;Thrombin time;High sensitivity C reactive protein;Erythrocyte sedimentation rate (ESR);Creatinine Clearance;Glomerular Filtration Rate (GFR);Stool guaiac;Ammonia (NH3);CSF protein;CSF glucose;CSF white blood cell count;CSF red blood cell count 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);Atrial natriuretic peptide (ANP);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);White Blood Cell Count (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;Glucose;Albumin;Total protein;Pre-Albumin;Phenytoin (Dilantin);Glucose D-stick;Glucose serum;Serum OSM;Partial Thromboplastin Time (PTT);Phenobarb;Cortisol;Direct bilirubin;Activated Partial Thromboplastin Time (aPTT);Fibrinogen;Thrombin time;High sensitivity C reactive protein;Erythrocyte sedimentation rate (ESR);Creatinine Clearance;Glomerular Filtration Rate (GFR);Stool guaiac;Ammonia (NH3);CSF protein;CSF glucose;CSF white blood cell count;CSF red blood cell count 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 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 Supplemental 3.00 2013-07-25 08:54:08.2 Laboratory Tests and Tracking Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 4000

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2183364
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 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

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 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

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 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

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

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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 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

2787947
CSV