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
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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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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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

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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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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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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C56109 CSF specimen amount taken value CSFSpecAmtTakenVal The value of the amount of CSF that was collected from the participant/subject. The value of the amount of CSF that was collected from the participant/subject. Amount of mL taken: Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 12:09:36.0 Biomarker-Related Sample and Collection Questions Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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milliliter
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

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/Biomarkers 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 collection. 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 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/Biomarkers 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 biomarkers. 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/Biomarkers 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/Biomarkers Assessments and Examinations 255

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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 centrifuged. 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/Biomarkers Assessments and Examinations

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G force
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/Biomarkers Assessments and Examinations 500

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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/Biomarkers 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 biomarkers. 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/Biomarkers 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 collection. 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/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

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/Biomarkers 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 biomarkers. 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/Biomarkers Assessments and Examinations

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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 specimen. 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/Biomarkers Assessments and Examinations

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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/Biomarkers Assessments and Examinations 255

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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/Biomarkers Assessments and Examinations

Multiple Pre-Defined Values Selected

C58427 Biomarker specimen collected aliqiot 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 biomarkers. Volume per aliquot: 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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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 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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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/Biomarkers Assessments and Examinations 255

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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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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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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
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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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
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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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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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
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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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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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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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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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

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
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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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

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
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
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
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

CSV