CDE Detailed Report

Disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Sub-Domain: Laboratory Tests and Biospecimens/Biomarkers
CRF: Biomarker-Related Sample and Collection Questions

Displaying 1 - 50 of 69
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 External Id Loinc External Id Snomed External Id caDSR External Id CDISC
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/Biomarkers 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 specimen. 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/Biomarkers Assessments and Examinations

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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 biomarkers. 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/Biomarkers Assessments and Examinations

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C57924 CSF specimen glucose value CSFSpecimenGlucVal Value of CSF specimen glucose. Value of CSF specimen glucose. 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/Biomarkers Assessments and Examinations

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1 100 milligram per decaliter
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/Biomarkers Assessments and Examinations 50

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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/Biomarkers Assessments and Examinations

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1 1000 milliliters
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/Biomarkers 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 specimen. 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/Biomarkers Assessments and Examinations

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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 biomarkers. 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/Biomarkers Assessments and Examinations

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C57925 Urine collected volume value UrineCollectVolVal Value of urine volume collected. Value of urine volume collected. 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/Biomarkers Assessments and Examinations

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milliliters
C55005 Specimen centrifugation duration SpecCentrifugationDur The duration related to centrifugation. The duration related to centrifugation. 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/Biomarkers Assessments and Examinations

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second
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/Biomarkers 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/Biomarkers Assessments and Examinations

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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 specimen. 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/Biomarkers Assessments and Examinations 255

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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/Biomarkers Assessments and Examinations

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3162729
C57926 Urine sample collection indicator UrineSampleCollectInd Indicate whether urine sample collected. Indicate whether urine sample collected. 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/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C55009 Specimen storage temperature value SpecStorTempVal The temperature value for the specimen being stored. The temperature value for the specimen being stored. 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/Biomarkers Assessments and Examinations

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degrees celsius
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/Biomarkers Assessments and Examinations

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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/Biomarkers 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 collection. 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/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

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/Biomarkers Assessments and Examinations

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3162729
C57927 Saliva collection volume value SalivaCollectnVolVal Value of saliva collected volume. Value of saliva collected volume. 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/Biomarkers Assessments and Examinations

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milliliters
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 biomarkers. 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/Biomarkers Assessments and Examinations

Multiple Pre-Defined Values Selected

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/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

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/Biomarkers Assessments and Examinations 50

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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 collection. 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/Biomarkers Assessments and Examinations 255

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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/Biomarkers Assessments and Examinations

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3162729
C57928 Saliva collection stimulation use indicator SalivaCollStimUseInd Indicate whether stimulation was used for saliva collection. Indicate whether stimulation was used for saliva collection. 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/Biomarkers 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 collected. 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/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

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/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

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/Biomarkers Assessments and Examinations 50

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C57374 Changed medication name text ChangedMedicationNameTxt Name of changed medication(s) taken by subject/participant. Name of changed medication(s) taken by subject/participant. 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/Biomarkers Assessments and Examinations 255

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C58464 Blood collection tube lysing stabilizing media text BloodCollectTubeLysStbMedTxt Free-text field to specify lysing/stabilizing media used in blood collection tube Free-text field to specify lysing/stabilizing media used in blood collection tube Lysing/stabilizing media, indicate additive Alphanumeric Adult;Pediatric Supplemental 1.00 2018-01-15 15:45:04.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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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 and time of specimen collection Date or Date & Time Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-25 08:54:08.2 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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2004004
C57929 Saliva collection oral hygiene use indicator SalivaCollOralHygieneUseInd Indicate whether oral hygiene used in saliva collection. Indicate whether oral hygiene used in saliva collection. Indicate if oral hygiene was used before collection: No (STOP);Yes, please describe No (STOP);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/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56107 Biomarker specimen other text BiomarkSpecOthrTxt The free-text field describing another type of specimen that was collected from the participant/subject. The free-text field describing another type of specimen that was collected from the participant/subject. Other, specify: Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 12:06:04.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 500

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C58412 Serum plasma sample collection processing elapse time interval SerPlsmSmpCollProcTimeIntrvl Elapsed time between sample collection and processing for serum and plasma samples Elapsed time between sample collection and processing for serum and plasma samples For serum/plasma, indicate timeframe between collection of blood and separation: Numeric Values Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-16 14:01:43.01 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C58423 Total protein value unit of measure TotalProteinValCountUOM Unit of measure for reporting total protein measurement Unit of measure for reporting total protein measurement Total protein 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/Biomarkers Assessments and Examinations 50

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C57375 Changed medication dose text ChangedMedicationDoseTxt Dose of changed medication(s) taken by subject/participant. Dose of changed medication(s) taken by subject/participant. Adjusted dose: Alphanumeric Adult;Pediatric Supplemental 1.00 2018-01-05 16:40:51.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C58465 Blood collection tube lysing stabilizing media concentration value BldCllectTubeLysStbMedConcVal Free-text field to specify concentration of lysing/stabilizing media used in blood collection tube Free-text field to specify concentration of lysing/stabilizing media used in blood collection tube Lysing/stabilizing media, indicate concentration Numeric Values Adult;Pediatric Supplemental 1.00 2018-01-15 15:45:04.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C10564 Fasting prior to sample collection indicator FastBeforeLabTestInd Indicator of whether or not the participant/subject was on fasting prior to blood sample collection Indicator whether participant/subject was fasting prior to collection of the sample on which the lab test being reported was performed Indicate if subject/participant was fasting when blood was collected Yes;No Yes;No Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C57930 Saliva collection oral hygiene use time SalivaCollOralHygieneUseTime Time of oral hygiene use in saliva collection. Time of oral hygiene use in saliva collection. Indicate time of oral hygiene procedure before collection: Date or Date & Time Adult;Pediatric Supplemental 1.00 2018-01-16 11:16:53.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C58413 Serum plasma sample storage temperature value SerPlsmSmpStorageTempVal Storage temperature used for serum and plasma samples Storage temperature used for serum and plasma samples For serum/plasma, indicate storage temperature: Numeric Values Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-16 14:01:43.01 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56108 CSF specimen opening pressure value CSFCollOpenPresVal The value of the opening pressure of the CSF specimen collected. The value of the opening pressure of the CSF specimen collected. Opening pressure: Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 12:08:24.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C58424 Saliva collection stimulation use text SalivaCollStimUseTxt Describe stimulation used in saliva collection Describe stimulation used in saliva collection 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/Biomarkers Assessments and Examinations 500

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C57377 Changed medication frequency status ChangedMedFreqStat Frequency status of changed medication given to subject/participant Frequency status of changed medication given to subject/participant If yes, what changes were made to the medication? Medication stopped;Dose increased;Frequency increased;Frequency decreased;Other, specify:;Dose decreased Medication stopped;Dose increased;Frequency increased;Frequency decreased;Other, specify: (e.g., route of administration changed);Dose decreased Alphanumeric Adult;Pediatric Supplemental 1.00 2018-01-05 16:54:26.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C58466 Biomarker specimen collected vial type BiomrkSpecCollectVialTyp The type of vial used for specimens collected from the participant/subject for biomarkers. The type of vial used for specimens collected from the participant/subject for biomarkers. Vial used: Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 11:44:03.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C17402 Site name SiteName The name of the site for the study The name of the site for the study Site Name Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C58402 Sample collection processing elapse time interval SmpCllctnPrcessElapsTimeIntrvl Elapsed time between sample collection and processing Elapsed time between sample collection and processing What time elapsed between collection and processing? Numeric Values Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-16 14:01:43.01 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C58414 Blood sample peripheral blood mononuclear cell isolation method type BloodSamplePBMCIsolatMethTyp Isolation method used for blood peripheral blood mononuclear cells Isolation method used for blood peripheral blood mononuclear cells For PBMCs, specify method of isolation: Ficoll;Cell prep tube (CPT);Other, specify Ficoll;Cell prep tube (CPT);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/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

CSV