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