CDE Detailed Report

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

Displaying 51 - 69 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
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 biomarker 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/subjec 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 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/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 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/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 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/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 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/Biomarkers 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/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 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/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 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/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

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/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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CSV