CDE Detailed Report

Disease: system
Subdomain Name: Laboratory Tests and Biospecimens%2FBiomarkers
CRF: files

Displaying 1 - 50 of 69
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
C57921 Blood collected volume value BloodCollectVolVal Volume of blood collected Volume of blood collected Indicate collected volume (ml) Numeric Values Adult;Pediatric Supplemental 1.00 2018-01-15 15:14:06.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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milliliters
C58425 Saliva collection oral hygiene use text SalivaCollOralHygieneUseTxt Describe oral hygiene used in saliva collection Describe oral hygiene used in saliva collectio Yes, please describe: Alphanumeric Adult;Pediatric Supplemental 1.00 2018-01-16 11:14:10.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 500

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C58403 Medication baseline modification before study start indicator MedBaselModifBefStdyStrtInd Indicator related whether there were modifications to baseline medications prior to study start Indicator related whether there were modifications to baseline medications prior to study start Were there any modifications made (by the subject, their physicians, or the researchers) to the subject's BASELINE medications right before the study commenced)? Yes;No (STOP);Unknown (STOP) Yes;No (STOP);Unknown (STOP) Alphanumeric Adult;Pediatric Supplemental-Highly Recommended 1.00 2018-01-05 16:54:26.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C58467 Biomarker specimen collected vial brand name BiomrkSpecCollectVialBrndName The brand name of vial used for specimens collected from the participant/subject for biomarkers The brand name of vial used for specimens collected from the participant/subject for biomarker Indicate brand name: Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 11:44:03.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 255

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C19247 Subject ID SubIDNam Subject identification ID Subject identification ID Subject ID Alphanumeric Adult;Pediatric Supplemental 1.00 2014-06-05 13:10:49.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 255

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C58415 Blood sample peripheral blood mononuclear cell isolation method other text BldSamplePBMCIsolatMethOthTxt Free-text field to describe other isolation method used for blood peripheral blood mononuclear cells Free-text field to describe other isolation method used for blood peripheral blood mononuclear cells Other, specify: Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 500

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C56111 Specimen centrifugation speed value SpecCentrSpeedVal The speed at which the specimen was centrifuged The speed at which the specimen was centrifuge Speed of centrifugation (in G force of speed and name of centrifugation) Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 12:11:18.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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G force
C57922 Blood collection system type BloodCollectSystTyp Indicate type of system used to collect blood Indicate type of system used to collect blood Indicate collecting system used Needle;Vacutainer Needle;Vacutainer Alphanumeric Adult;Pediatric Supplemental 1.00 2018-01-15 15:21:23.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C58426 Biomarker specimen collected aliquot number BiomrkSpecCollectAliquotNum The number of aliquots made for specimens collected from the participant/subject for biomarkers The number of aliquots made for specimens collected from the participant/subject for biomarker Number of aliquots: Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:44:03.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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C58405 Changed medication frequency other text ChangedMedFreqOthTxt Free-text field to describe change(s) to medication Changed medication frequency status Other, specify: Alphanumeric

E.g., route of administration changed

Adult;Pediatric Supplemental 1.00 2018-01-05 16:54:26.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 255

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C58468 Biomarker specimen collected vial catalog number BiomrkSpecCollectVialCtlgNum The catalog number of vial used for specimens collected from the participant/subject for biomarkers The catalog number of vial used for specimens collected from the participant/subject for biomarker Catalog number: Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:44:03.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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C54753 Specimen collection tube type SpecimenCollectionTubTyp Type of tube used for specimen collection Type of tube used for specimen collectio Specify collection tube: Other, specify;Polystyrene tubes;Polypropylene tubes Other, specify;Polystyrene tubes;Polypropylene tubes Alphanumeric

Choose one

Adult;Pediatric Supplemental 1.00 2017-04-11 12:19:20.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C58416 Ficoll brand name FicollBrandName Name of the brand of Ficoll used Name of the brand of Ficoll used Ficoll: Indicate brand name Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 255

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C56113 CSF specimen white blood cell count CSFSpecWBCCt The number of white blood cells (WBCs) counted in the participant's CSF specimen The number of white blood cells (WBCs) counted in the participant's CSF specime WBC Cell count (include units): Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 12:18:30.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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C57923 Blood collection tube additive type BloodCollectTubeAdditivTyp Type of additives used in blood collection tube Type of additives used in blood collection tube Specify additives in collection tube: EDTA;Citrate;Heparin;Lysing/stabilizing media;None EDTA;Citrate;Heparin;Lysing/stabilizing media;None Alphanumeric

Choose one

Adult;Pediatric Supplemental 1.00 2018-01-15 15:45:04.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

Multiple Pre-Defined Values Selected

C58427 Biomarker specimen collected aliquot volume value BiomrkSpecCollectAliquotVolVal The volume per aliquot for pecimens collected from the participant/subject for biomarkers The volume per aliquot for pecimens collected from the participant/subject for biomarker Volume per aliquot: Numeric Values Adult;Pediatric Supplemental 1.10 2022-08-04 10:29:56.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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C58406 Change medication time status text ChangedMedTimeStatTxt Free-text field to specify changes to medication Free-text field to specify changes to medication If yes, when did the changes occur relative to when a test, treatment, or other intervention was performed? Alphanumeric

e.g., 24 hours before blood draw, 4 weeks prior to treatment, etc.

Adult;Pediatric Supplemental 1.00 2018-01-05 16:54:26.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 255

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C54754 Specimen collection tube other text SpecimenCollectionTubOTH The free-text field related to other tube for specimen collection The free-text field related to other tube for specimen collectio Other, specify: Alphanumeric Adult;Pediatric Supplemental 1.00 2017-04-11 12:19:20.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 255

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C58417 Ficoll catalog number FicollCataNum Ficoll catalog number Ficoll catalog number Ficoll: Indicate catalog number: Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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C56114 CSF specimen red blood cell count CSFSpecRBCCt The number of red blood cells (RBCs) counted in the participant's CSF specimen The number of red blood cells (RBCs) counted in the participant's CSF specime RBC Cell count (include units): Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 12:18:30.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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C57924 CSF specimen glucose value CSFSpecimenGlucVal Value of CSF specimen glucose Value of CSF specimen glucos Glucose (include units): Numeric Values Adult;Pediatric Supplemental 1.00 2018-01-15 16:07:31.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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1 100 milligram per decaliter
C58428 Biomarker specimen collected aliquot cell number BiomrkSpecCollectAliqutCellNum The cells per aliquot for specimens collected from the participant/subject for biomarkers The cells per aliquot for specimens collected from the participant/subject for biomarker Number of cells per aliquot: Numeric Values

If applicable

Adult;Pediatric Supplemental 1.00 2017-06-06 11:44:03.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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C58407 Blood collection tube volume value BloodCollectTubeVolVal Volume of blood collection tube Volume of blood collection tube Indicate collected volume (ml) Numeric Values Adult;Pediatric Supplemental 1.00 2018-01-15 15:14:06.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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1 1000 milliliters
C54941 Blood glucose unit of measure BloodGlucoseUOM Unit of measure for reporting blood glucose values Unit of measure for reporting blood glucose values Glucose unit of measure Alphanumeric Adult;Pediatric Supplemental 1.00 2017-04-13 13:15:56.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 50

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C58418 Ficoll volume ratio used value FicollVolRatioUsedVal Ficoll volume ratio used Ficoll volume ratio used Ficoll: Indicate volume ratio used: Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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C56117 CSF specimen total protein value CSFSpecTotProtVal The value representing the total protein found in the participant's CSF specimen The value representing the total protein found in the participant's CSF specime Total Protein (include units): Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 13:15:22.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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C57925 Urine collected volume value UrineCollectVolVal Value of urine volume collected Value of urine volume collecte Indicate volume collected (ml): Numeric Values Adult;Pediatric Supplemental 1.00 2018-01-15 16:17:47.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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milliliters
C58429 Biomarker specimen collected final storage temperature value BiomrkSpcCllectFinalStrgTmpVal The final storage temperature for specimens collected from the participant/subject for biomarkers The final storage temperature for specimens collected from the participant/subject for biomarker Final storage temperature: Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:44:03.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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C58408 Blood collection tube brand name BloodCollectTubeBrandName Name of the brand of blood collection tube Name of the brand of blood collection tube Indicate brand name Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 255

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C55005 Specimen centrifugation duration SpecCentrifugationDur The duration related to centrifugation The duration related to centrifugatio Duration of centrifugation Numeric Values Adult;Pediatric Supplemental 1.00 2017-04-17 14:55:46.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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second
C56118 CSF specimen test for hemoglobin contaminant method text CSFSpecTestHemoContMethTxt Text describing the method of testing for hemoglobin contaminants in the participant's CSF specimen Text describing the method of testing for hemoglobin contaminants in the participant's CSF specime Method of testing for hemoglobin contaminants: Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 13:16:32.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 255

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C58419 Blood collection peripheral blood mononuclear cell isolation time elapsed value BldCollectPBMCIsolTimeElpsVal The time elapsed between blood collectioon and isolation of periphral blood mononuclear cells The time elapsed between blood collectioon and isolation of periphral blood mononuclear cells Indicate timeframe between blood collection and isolation of PBMCs: Numeric Values Adult;Pediatric Supplemental 1.00 2017-04-17 15:19:20.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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C57926 Urine sample collection indicator UrineSampleCollectInd Indicate whether urine sample collected Indicate whether urine sample collecte Indicate if collected sample was first morning stream No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2018-01-16 10:38:45.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C58461 Medication initial dose MedctnInitialDose Initial dose of medication taken per administration prior to adjustments Initial dose of medicaiton taken per administration prior to adjustments Initial dose: Numeric Values Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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3162729
C58409 Blood collection tube catalog number BloodCollectTubeCataNum Catalog number of blood collection tube Catalog number of blood collection tube Indicate catalog number: Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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C55009 Specimen storage temperature value SpecStorTempVal The temperature value for the specimen being stored The temperature value for the specimen being store What temperature was the sample stored at prior to processing? Numeric Values Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-04-17 15:19:20.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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degrees celsius
C56120 CSF Specimen collection tube type CSFSpecimenCollectionTubTyp The type related to tube for CSF specimen collection The type related to tube for CSF specimen collectio Specify collection tube: Polypropylene tubes;Polystyrene tubes;Other, specify Polypropylene tubes;Polystyrene tubes;Other, specify Alphanumeric

Choose one

Adult;Pediatric Supplemental 1.00 2017-04-11 12:19:20.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C58420 Blood collection peripheral blood mononuclear cell isolation temperature storage value BldCollectPBMCIsolTempStorVal Storage temperature used between blood collectioon and isolation of periphral blood mononuclear cells Storage temperature used between blood collectioon and isolation of periphral blood mononuclear cells Indicate storage temperature between blood collection and isolation of PBMCs: Numeric Values Adult;Pediatric Supplemental 1.00 2017-04-17 15:19:20.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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degrees celsius
C57927 Saliva collection volume value SalivaCollectnVolVal Value of saliva collected volume Value of saliva collected volum Indicate collected volume (ml): Numeric Values Adult;Pediatric Supplemental 1.00 2018-01-16 10:59:38.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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milliliters
C58462 Medication initial frequency MedctnInitialFreq Initial frequency of medication taken per administration prior to adjustments Initial frequency of medicaiton taken per administration prior to adjustments Initial frequency: Numeric Values Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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3162729
C58410 Blood collection tube sterile indicator BloodCollectTubeSterileInd Indicator related to whether blood collection tube is sterile Indicator related to whether blood collection tube is sterile Indicate if tubes are sterile: No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56102 Biomarker specimen type BiomarkSpecTyp The type of specimen or specimens collected from the participant/subject for biomarkers The type of specimen or specimens collected from the participant/subject for biomarker What type of specimen was collected from the subject/participant? Blood, specify type;CSF, complete the following;Urine;Saliva;Other, specify Blood, specify type;CSF, complete the following;Urine;Saliva;Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 11:44:03.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

Multiple Pre-Defined Values Selected

C56121 CSF specimen collection tube other text CSFSpecimenCollectionTubOTH The free-text field related to other tube for CSF specimen collection The free-text field related to other tube for CSF specimen collectio Other, specify: Alphanumeric Adult;Pediatric Supplemental 1.00 2017-04-11 12:19:20.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 255

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C58421 White blood cell count unit of measure WBCCountUOM Unit of measure for reporting white blood cell count Unit of measure for reporting white blood cell coun WBC units Alphanumeric Adult;Pediatric Supplemental 1.00 2017-04-13 13:15:56.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 50

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C57928 Saliva collection stimulation use indicator SalivaCollStimUseInd Indicate whether stimulation was used for saliva collection Indicate whether stimulation was used for saliva collectio Indicate if stimulation was used: No (STOP);Yes, please describe No (STOP);Yes, please describe Alphanumeric Adult;Pediatric Supplemental 1.00 2018-01-16 11:01:33.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C58463 Medication adjusted frequency MedctnAdjFreq Adjusted frequency of medication taken per administration prior to adjustments Adjusted frequency of medicaiton taken per administration prior to adjustments Adjusted frequency: Numeric Values Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

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3162729
C58411 Blood collection tube endotoxin free indicator BloodCollectTubeEndoFreeInd Indicator related to whether blood collection tube is endotoxin-free Indicator related to whether blood collection tube is endotoxin-free Indicate if tubes are endotoxin-free: No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56106 Specimen blood collection type SpecBldCollTyp The type of blood component that was collected The type of blood component that was collecte Blood, specify type: Platelet-free plasma;Platelet-rich plasma;Serum;Whole blood;PBMC Platelet-free plasma;Platelet-rich plasma;Serum;Whole blood;PBMC (Peripheral blood mononuclear cell) Alphanumeric

Choose one

Adult;Pediatric Supplemental 1.00 2017-06-06 12:00:52.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C57374 Changed medication name text ChangedMedicationNameTxt Name of changed medication(s) taken by subject/participant Name of changed medication(s) taken by subject/participan If yes, name of the medication or class of medication Alphanumeric Adult;Pediatric Supplemental 1.00 2018-01-05 16:40:51.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 255

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C58422 Red blood cell count unit of measure RBCCountUOM Unit of measure for reporting red blood cell count Unit of measure for reporting red blood cell coun RBC unit of measure Alphanumeric Adult;Pediatric Supplemental 1.00 2017-04-13 13:15:56.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens%2FBiomarkers Assessments and Examinations 50

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CSV