CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Assessments and Examinations
CRF: Laboratory Tests

19 results.
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (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 / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type Source Form Set Form Field Domain CDASH Variable CDASH Definition CDASH Label Controlled Terminology Prompt Essentiality Question Text CDASH imp guidance SDTM IG target csDSR PhenX Data Type CRF Completion Inst SDTMIG Target Var SDTMIG Target Map Codelist Name PVs Pre Pop Value Query Display List Style
C01706 Lab test result text LabTestResltTxt Result of the laboratory test Result of the laboratory test Result Alphanumeric Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers 4000

Free-Form Entry

2183364 LB LBORRES

Lab Result or Finding in Original Units

Result

What was the result of the lab test?

LBORRES Char Record laboratory test result. Prompt
C60150 Test not done reason TestNotDoneRsn Reason why the test was not performed. Reason why the test was not performed. If 'Blood gas sample collect indicator' = No, Reason not done Alphanumeric Adult;Pediatric Core 1.00 2021-01-19 10:26:40.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers 255

Free-Form Entry

LB LBREASND

Reason Not Done

Reason Not Done

What was the reason that the sample was not collected?

LBREASND Char Record the reason the lab speciment was not collected. Prompt
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 Alphanumeric Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers 255

Free-Form Entry

2787947 LB LBORRESU

Lab Original Units

Unit

What was the unit of the lab result?

LBORRESU Char Record or select the original unit in which these data were collected. (UNIT)

[Select appropriate values from the UNIT codelist]

Prompt Radio
C60151 Lab test result compare reference range status LabTstRsltCmprRefRngStat Status of lab test result in comparison to reference range. Status of lab test result in comparison to reference range. Comparison to Reference Range Abnormal;Normal;Abnormal;Normal Abnormal;Normal;Abnormal;Normal Alphanumeric Adult;Pediatric Core 1.00 2021-01-21 14:06:22.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers

Single Pre-Defined Value Selected

LB LBNRIND

Lab Reference Range Indicator

Comparison to Reference Range

How do the reported values compare within the reference range?

LBNRIND Char Record where the lab result fell with respect to the reference range (e.g. HIGH, LOW, ABNORMAL). (NRIND)

High; Normal; Low

Prompt Radio
C17409 Visit date VisitDate Date of interview or visit (actually the date when data in the form were captured) Date of interview or visit Visit Date Date or Date & Time Adult;Pediatric Core 3.00 2013-06-21 00:00:00.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers

Free-Form Entry

DeBaun Forms LB VISDAT

Visit Date

Visit Date

What [is/was] the date of the visit?

N/A Char Record the [date/start date] of the visit using DD-MON-YYYY format. Prompt
C60152 Lab test result clinical significance indicator LabTstRsltClinSigInd Indicator of whether the lab test result is clinically significant. Indicator of whether the lab test result is clinically significant. Clinically Significant No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2021-01-21 14:11:49.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers

Single Pre-Defined Value Selected

LB LBCLSIG

Lab Clinical Significance

Clinically Significant

Was this result clinically significant?

SUPPLB.QVAL Char Record whether laboratory test results were clinically significant.

SUPPLB.QVAL where SUPPLB.QNAM = "LBCLSIG" and SUPPLB.QLABEL = "Clinically Significant"

(NY)

Yes; No

Prompt Radio
C60142 Blood sample collect indicator BloodSmplCollectInd Indicator of whether a sample of the subject/participant's blood was collected. Indicator of whether a sample of the subject/participant's blood was collected. Sample collected No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2021-01-15 16:26:53.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers

Single Pre-Defined Value Selected

LB LBPERF

Lab Performed

Sample Collected

Was the sample collected?

LBSTAT Char Indicate whether or not lab specimen was collected or measurement performed.

LBSTAT = "NOT DONE" when LBPERF = "N" and LBSTAT = null when LBPERF = "Y"

(NY)

Yes; No

Prompt Radio
C60153 Laboratory test hemoglobin analysis method type LabTestHgbAnlysMethodTyp Type of lab test method employed for hemoglobin analysis. Type of lab test method employed for hemoglobin analysis. Method of Test Gel electrophoresis;Isoelectric focusing;Capillary zone electrophoresis;High performance liquid chromatography;Unknown Gel electrophoresis;Isoelectric focusing (IE);Capillary zone electrophoresis (CZE);High performance liquid chromatography (HPLC);Unknown Alphanumeric Adult;Pediatric Core 1.00 2021-01-21 14:15:17.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers

Single Pre-Defined Value Selected

LB LBMETHOD

Lab Method of Test or Examination

Method of Test

What was the method used for the lab test or examination?

LBMETHOD Char Record the method of Test or Examination. (METHOD)

[Select appropriate values from the METHOD codelist]

Prompt
C60143 Blood sample not collect reason BloodSamplNotCollectRsn Reason that a sample of the subject/participant's blood was not collected. Reason that a sample of the subject/participant's blood was not collected. Reason not done Alphanumeric Adult;Pediatric Core 1.00 2021-01-15 16:38:38.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers 255

Free-Form Entry

LB LBREASND

Reason Not Done

Reason Not Done

What was the reason that the sample was not collected?

LBREASND Char Record the reason the lab speciment was not collected. Prompt
C60154 Hemoglobin test other name HgbTestOthName The free-text field related to "Lab test name" specifying other hemoglobin test name. The free-text field related to "Lab test name" specifying other hemoglobin test name. Specify other hemoglobin Alphanumeric Adult;Pediatric Core 1.00 2021-01-22 11:03:12.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers 50

Free-Form Entry

LB LBTEST

Lab Test or Examination Name

Laboratory Test Name

What was the lab test name?

LBTEST; LBTESTCD Char Record the name of the Lab measurement or finding, if not preprinted on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.

Assign LBTESTCD and LBTEST using Controlled Terminology based on input from the free text.

(LBTEST)

[Select appropriate values from the LBTEST codelist]

Prompt Radio
C60144 Blood sample collect date BloodSamplCollectDate Date on which a sample of the subject/participant's blood was collected. Date on which a sample of the subject/participant's blood was collected. Collection Date Date or Date & Time Adult;Pediatric Core 1.00 2021-01-15 16:40:21.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers

Free-Form Entry

LB LBDAT

Specimen Collection Date

Collection Date

What was the date of the lab specimen collection?

LBDTC Char Record the date when specimen collection was done using this format (DD-MON-YYYY). Prompt
C60350 Blood sample collect time BloodSamplCollectTime Time at which a sample of the subject/participant's blood was collected. Time at which a sample of the subject/participant's blood was collected. Collection Time Date or Date & Time Adult;Pediatric Core 1.00 2021-01-15 16:40:21.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers

Free-Form Entry

LB LBTIM

Specimen Collection Time

Collection Time

What was the time of the lab specimen collection?

LBDTC Char Record time of collection (as complete as possible).

This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.

Prompt
C60145 Blood sample accession number text BloodSamplAccessnNumTxt Text field for recording numeric or alphanumeric accession number of blood sample collected. Text field for recording numeric or alphanumeric accession number of blood sample collected. Accession Number Alphanumeric Adult;Pediatric Core 1.00 2021-01-15 16:43:56.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers 50

Free-Form Entry

LB LBREFID

Lab Specimen ID

Accession Number

What was the accession number?

LBREFID Char Record the specimen or accession number assigned. Prompt
C60146 Antiglobulin test direct result status AntiglobulinTestDirectRsltStat Status of the result of the direct antiglobulin test. Status of the result of the direct antiglobulin test. Antiglobulin Test, Direct Positive;Negative Positive;Negative Alphanumeric Adult;Pediatric Core 1.00 2021-01-15 16:46:24.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers

Single Pre-Defined Value Selected

LB ANGLOBDR_LBORRES

Lab Result or Finding in Original Units

Antiglobulin Test, Direct

What was the antiglobulin test, direct result?

LBORRES Char Record laboratory test result.

LBORRES when LBTESTCD = "ANGLOBDR"

Prompt
C60147 Antiglobulin test indirect result status AntiglobulinTstIndirctRsltStat Status of the result of the indirect antiglobulin test. Status of the result of the indirect antiglobulin test. Antiglobulin Test, Indirect Abnormal;Normal;Abnormal;Normal Abnormal;Normal;Abnormal;Normal Alphanumeric Adult;Pediatric Core 1.00 2021-01-15 16:46:24.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers

Single Pre-Defined Value Selected

LB ANGLBIND_LBORRES

Lab Result or Finding in Original Units

Antiglobulin Test, Indirect

What was the antiglobulin test, indirect result?

LBORRES Char Record laboratory test result.

LBORRES when LBTESTCD = "ANGLBIND"

Prompt
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 Collection Date and Time Date or Date & Time Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers

Free-Form Entry

2004004 DeBaun Forms LB LBDTC

Specimen Collection Date

Collection Date

What was the date of the lab specimen collection?

LBDTC Char Record the date when specimen collection was done using this format (DD-MON-YYYY). Prompt
C60148 Blood ABO type BloodABOTyp Type of the subject/participant's blood using the ABO and Rh factor designations. Type of the subject/participant's blood using the ABO and Rh factor designations. ABO Blood Group A-;A+;AB-;AB+;B-;B+;O-;O+ A-;A+;AB-;AB+;B-;B+;O-;O+ Alphanumeric Adult;Pediatric Core 1.00 2021-01-19 08:30:43.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers

Single Pre-Defined Value Selected

LB ABO_LBORRES

Lab Result or Finding in Original Units

ABO Blood Group

What was the ABO blood group result?

LBORRES Char Record laboratory test result.

LBORRES when LBTESTCD = "ABO"

Prompt
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. Laboratory test name 25-Hydroxyvitamin D;Activated Partial Thromboplastin Time;Activated Protein C Resistance;Alanine Aminotransferase;Albumin;Albumin/Creatinine;Alkaline Phosphatase;Ammonia;Amylase;Anion Gap;Antithrombin Antigen;Apolipoprotein A1;Apolipoprotein B;Apolipoprotein E;Aspartate Aminotransferase;Bicarbonate;Bilirubin;Brain Natriuretic Peptide;BUN/Creatinine;C Reactive Protein;Calcium;Calcium, Ionized;Chloride;Cholesterol;Choriogonadotropin Beta;Creatine Kinase;Creatine Kinase MB;Creatinine;Creatinine Clearance (24-hr);D-dimer;Dilute Russell's Viper Venom Time Ratio;Direct bilirubin;Eosinophils;Ery. Mean Corpuscular HGB Concentration;Ery. Mean Corpuscular Volume;Erythrocytes;Factor V Leiden;Factor XIV Activity;Ferritin;Fibrinogen;Folate (Erythrocytes);Fructosamine;Glomerular Filtration Rate, Estimated (Cockcroft-Gault Formula);Glucose;HDL Cholesterol;Hematocrit;Hemoglobin;Hemoglobin A;Hemoglobin A, Genetic Modified Variant;Hemoglobin A2;Hemoglobin C;Hemoglobin F;Hemoglobin S;Hemoglobin, Other;Hepatitis A Virus Antibody;Hepatitis B Virus Antibody;Hepatitis B Virus Core Antibody;Hepatitis B Virus Surface Antibody;Hepatitis B Virus Surface Antigen;Hepatitis C Virus Antibody;HIV-1 Antigen;Homocysteine;Iron;Lactate;LDL Cholesterol;Leukocytes;Lipoprotein-a;Lupus Anticoagulant Sensitive APTT;Lymphocytes;Lymphocytes/Leukocytes;Magnesium;Methylene Tetrahydrofolate Reductase;Methylmalonic acid;Monocytes;Neutrophils;Neutrophils/Leukocytes;Occult Blood;Partial Pressure Carbon Dioxide;Partial Pressure Oxygen;Parvovirus B19 IgG Antibody;Parvovirus B19 IgM Antibody;Parvovirus DNA;Phosphate;Plasminogen;Platelets;Potassium;Protein;Protein S, Free;Protein/Creatinine;Prothrombin Intl. Normalized Ratio;Prothrombin Time;RBC Casts;Reticulocytes;SARS-CoV-2 IgG Antibody;SARS-CoV-2 RNA;Sodium;Soluble Transferrin Receptor;Specific gravity;Thrombin time;Total Iron Binding Capacity;Transferrin Saturation;Triglycerides;Troponin I;Troponin T;Urate;Urea Nitrogen;Vitamin B12;VLDL Cholesterol;WBC Casts;pH 25-Hydroxyvitamin D;Activated Partial Thromboplastin Time;Activated Protein C Resistance;Alanine Aminotransferase;Albumin;Albumin/Creatinine;Alkaline Phosphatase;Ammonia;Amylase;Anion Gap;Antithrombin Antigen;Apolipoprotein A1;Apolipoprotein B;Apolipoprotein E;Aspartate Aminotransferase;Bicarbonate;Bilirubin;Brain Natriuretic Peptide;BUN/Creatinine;C Reactive Protein;Calcium;Calcium, Ionized;Chloride;Cholesterol;Choriogonadotropin Beta;Creatine Kinase;Creatine Kinase MB;Creatinine;Creatinine Clearance (24-hr);D-dimer;Dilute Russell's Viper Venom Time Ratio;Direct bilirubin;Eosinophils;Ery. Mean Corpuscular HGB Concentration;Ery. Mean Corpuscular Volume;Erythrocytes;Factor V Leiden;Factor XIV Activity;Ferritin;Fibrinogen;Folate (Erythrocytes);Fructosamine;Glomerular Filtration Rate, Estimated (Cockcroft-Gault Formula);Glucose;HDL Cholesterol;Hematocrit;Hemoglobin;Hemoglobin A;Hemoglobin A, Genetic Modified Variant;Hemoglobin A2;Hemoglobin C;Hemoglobin F;Hemoglobin S;Hemoglobin, Other;Hepatitis A Virus Antibody;Hepatitis B Virus Antibody;Hepatitis B Virus Core Antibody;Hepatitis B Virus Surface Antibody;Hepatitis B Virus Surface Antigen;Hepatitis C Virus Antibody;HIV-1 Antigen;Homocysteine;Iron;Lactate;LDL Cholesterol;Leukocytes;Lipoprotein-a;Lupus Anticoagulant Sensitive APTT;Lymphocytes;Lymphocytes/Leukocytes;Magnesium;Methylene Tetrahydrofolate Reductase;Methylmalonic acid;Monocytes;Neutrophils;Neutrophils/Leukocytes;Occult Blood;Partial Pressure Carbon Dioxide;Partial Pressure Oxygen;Parvovirus B19 IgG Antibody;Parvovirus B19 IgM Antibody;Parvovirus DNA;Phosphate;Plasminogen;Platelets;Potassium;Protein;Protein S, Free;Protein/Creatinine;Prothrombin Intl. Normalized Ratio;Prothrombin Time;RBC Casts;Reticulocytes;SARS-CoV-2 IgG Antibody;SARS-CoV-2 RNA;Sodium;Soluble Transferrin Receptor;Specific gravity;Thrombin time;Total Iron Binding Capacity;Transferrin Saturation;Triglycerides;Troponin I;Troponin T;Urate;Urea Nitrogen;Vitamin B12;VLDL Cholesterol;WBC Casts;pH Alphanumeric Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers

Single Pre-Defined Value Selected

2003746 DeBaun Forms LB LBTEST

Lab Test or Examination Name

Laboratory Test Name

What was the lab test name?

LBTEST; LBTESTCD Char Record the name of the Lab measurement or finding, if not preprinted on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended. (LBTEST)

[Select appropriate values from the LBTEST codelist]

Prompt Radio
C60149 Blood gas sample collect indicator BloodGasSampleCollectInd Indicator of whether a blood gas sample was collected. Indicator of whether a blood gas sample was collected. Sample collected No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2021-01-19 09:43:19.0 Laboratory Tests Assessments and Examinations Laboratory Tests and Biospecimens/Biomarkers

Single Pre-Defined Value Selected

LB LBPERF

Lab Performed

Sample Collected

Was the sample collected?

LBSTAT Char Indicate whether or not lab specimen was collected or measurement performed.

LBSTAT = "NOT DONE" when LBPERF = "N" and LBSTAT = null when LBPERF = "Y"

(NY)

Yes; No

Prompt Radio
19 results.
CSV