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
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

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

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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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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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

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
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

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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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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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

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
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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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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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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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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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

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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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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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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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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CSV