CDE Detailed Report

Disease: content
Subdomain Name: Laboratory Tests and Biospecimens/Biomarkers
CRF: welcome

Displaying 1 - 50 of 84
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
C56146 Assay result other text AssayResltOthrTxt The free-text field describing another result from the assay The free-text field describing another result from the assa Other, specify Alphanumeric Adult;Pediatric Exploratory 1.00 2017-06-06 13:55:08.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C16177 Post-menopausal indicator PostMnpslInd Indicates whether participant is post-menopausal Indicates whether participant/subject is post-menopausal Is the participant/subject currently postmenopausal? Yes;No;Unknown Yes;No;Unknown Alphanumeric

To be answered for women only

Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-06-11 00:00:00.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56097 Blood time collection storage interval BldTimeCollStorIntrvl The interval between the time blood was collected and stored The interval between the time blood was collected and store Blood Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:33:17.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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minute
C56057 Headache ictal indicator HeadacheIctalInd The indicator relating to whether the headache was ictal The indicator relating to whether the headache was icta Was headache ictal? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 10:16:38.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

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 Numeric Values

Include units

Adult;Pediatric Supplemental 1.00 2017-06-06 12:18:30.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

C56130 Original specimen repeated refrozen rethawed indicator OrgnSpecRepeatRefRethInd The indicator relating to whether the original specimen has been repeatedly re-frozen or re-thawed The indicator relating to whether the original specimen has been repeatedly re-frozen or re-thawe Has the original specimen been repeatedly re-frozen or re-thawed? Yes;No (Skip to next section);Unknown (Skip to next section) Yes;No (Skip to next section);Unknown (Skip to next section) Alphanumeric

If repeated samples were done, then questions 6-8 need to be repeated for each cycle.

Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-06 13:34:09.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C15607 Medication history change indicator MedctnHistChngInd Whether or not the participant/subject had a change in his or her medication around the time of specimen collection Whether or not the participant/subject had a change in his or her medication around the time of specimen collectio Indicate whether any medication changes have recently occurred prior to the sample? Yes;No;Unknown Yes;No;Unknown Alphanumeric

These elements should be captured on other study specific source documents (e.g. Headache Diary, and Prior and Concomitant Medications) and should be pre-populated if initially collected elsewhere to avoud redundant data points.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56080 Over the counter medication supplement name OTCMedSuppName The name of the participant's over-the-counter medication and/or supplements The name of the participant's over-the-counter medication and/or supplement Name Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 11:03:02.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 500

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C56147 Headache free after specimen collection verified duration HeadFreeAftrSpecCollVerDur The duration of time which the participant was verified to be headache-free after specimen collection The duration of time which the participant was verified to be headache-free after specimen collectio State the length of time participant was VERIFIED to be a headache free after specimen collection Date or Date & Time Adult;Pediatric Exploratory 1.00 2017-06-06 13:55:58.0 Biospecimens Collection and Processing 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 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56098 Sample temperature before centrifugation storage value SampTempBefCentStorVal The temperature of the biomarker sample before centrifugation or storage The temperature of the biomarker sample before centrifugation or storag Temperature before centrifugation or storage (i.e. was the sample collected at room temperature or on ice) Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:38:23.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

degrees Celsius
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 Numeric Values

Include units

Adult;Pediatric Supplemental 1.00 2017-06-06 13:15:22.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56059 Headache 28 day prior sample collection rate Headache28DayPriSampCollRt The rate of the participant's headaches during the 28 days prior to sample collection The rate of the participant's headaches during the 28 days prior to sample collection Record 28-day headache days frequency prior to sample collection No headaches in the past 28 days;<1 day per month in the past 28 days;1-4 days in the past 28 days;5-9 days in the past 28 days;10-14 days in the past 28 days;15 or more days in the past 28 days No headaches in the past 28 days;<1 day per month in the past 28 days;1-4 days in the past 28 days;5-9 days in the past 28 days;10-14 days in the past 28 days;15 or more days in the past 28 days Alphanumeric Adult;Pediatric Core 2.00 2022-02-08 12:33:59.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56131 Frozen aliquot volume value FrozenAliquotVolVal The value representing the volume of the frozen aliquot of the sample The value representing the volume of the frozen aliquot of the sampl Frozen aliquot volume Numeric Values

Record and indicate which unit of measure is being used (mL or ?L).

Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-06 13:35:56.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C15618 Premenopausal indicator PremenpausInd Whether or not the participant/subject is currently in her premenopausal phase Whether or not the participant/subject is currently in her premenopausal phas Is the participant/subject currently premenopausal? Yes;No;Unknown Yes;No;Unknown Alphanumeric

To be answered for women only

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-16 14:01:43.01 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56081 Over the counter medication supplement dose OTCMedSuppDose The dose of the participant's over-the-counter medication and/or supplements The dose of the participant's over-the-counter medication and/or supplement Dose Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:05:51.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

C56148 Headache type text HeadahceTypTxt Text specifying the type of headache the participant/subject had, has, or is having Text specifying the type of headache the participant/subject had, has, or is havin Type of headache, specify Alphanumeric Adult;Pediatric Exploratory 1.00 2017-06-06 13:57:46.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

Free-Form Entry

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 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

Free-Form Entry

C56100 CSF time storage analysis interval CSFTimeStorAnaIntrvl The interval of time between CSF storage and analysis The interval of time between CSF storage and analysi CSF Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:40:22.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

minute
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 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C56060 Timeframe window between medication change specimen collection duration TimeWindBtwnMedChngSpecCollDur The timeframe window between medication changes and specimen collection The timeframe window between medication changes and specimen collectio If yes, specify timeframe window between medication changes and specimen collection Less than 1 week;1-2 weeks;3-4 weeks;1-3 months;>3 months Less than 1 week;1-2 weeks;3-4 weeks;1-3 months;>3 months Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 10:21:56.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56133 Frozen aliquot volume unit of measure FrozenAliquotVolUoM The unit the frozen aliquot volume was measured in The unit the frozen aliquot volume was measured i Frozen aliquot volume milliliters (mL);microliters (?L) milliliters (mL);microliters (?L) Alphanumeric

Please specify

Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-06 13:36:45.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C15621 Menstrual cycle day collection time value MenstrlCyclDayCollctnTimeVal Specify day of cycle (e.g. first day of menses is day 0) at time of sample collection Specify day of cycle (e.g. first day of menses is day 0) at time of sample collection If premenopausal or perimenopausal, specify day of cycle (e.g. first day of menses is day 0) at time of sample collection Numeric Values

To be answered for females only

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

C56082 Over the counter medication supplement quantity value OTCMedSuppQuanVal The value representing the quantity of the participant's over-the-counter medication and/or supplements The value representing the quantity of the participant's over-the-counter medication and/or supplement Quantity Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:07:16.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56149 Headache treatment type HeadacheTreatmtTyp The type of treatment for the participant's headache The type of treatment for the participant's headach Treatment for this headache Bed rest;Blood patch for post puncture headache;Other, specify Bed rest;Blood patch for post puncture headache;Other, specify Alphanumeric Adult;Pediatric Exploratory 1.00 2017-06-06 13:58:39.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C55004 Specimen centrifugation temperature value SpecCentrifugationTempVal The value related to temperature in a centrifuge The value related to temperature in a centrifug Temperature of centrifugation Numeric Values

please specify in ?C

Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-04-17 14:55:46.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

degrees celsius
C56101 Blood time storage analysis interval BloodTimeStorAnaIntrvl The interval of time between blood storage and analysis The interval of time between blood storage and analysi Blood Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:40:22.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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minute
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 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56063 Blood sample last acute abortive time BldSampLastAcuteAbortTime The time the last acute abortive was taken in relationship to the blood sample The time the last acute abortive was taken in relationship to the blood sampl In relationship to the blood sample, what time was the last acute abortive was taken? Date or Date & Time Adult;Pediatric Supplemental 1.00 2017-06-06 10:25:57.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56134 Specimen freezing time SpecFreezeTime The time of specimen freezing The time of specimen freezing Time of specimen freezing Date or Date & Time Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-06 13:39:26.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C15624 Pregnancy indicator PregInd Indicates if the participant/subject is currently pregnant Indicates if the participant/subject is currently pregnant Is the participant/subject currently pregnant? Yes;No;Unknown Yes;No;Unknown Alphanumeric

To be answered for women only

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56086 Recreational substance name RecSubstanceName The name of the recreational substance the participant uses The name of the recreational substance the participant use Name Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 11:10:00.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C56150 Headache treatment other text HeadahceTreatmtOthrTxt The free-text field describing another type of headache treatment The free-text field describing another type of headache treatmen Other, specify Alphanumeric Adult;Pediatric Exploratory 1.00 2017-06-06 14:00:12.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

Free-Form Entry

C55005 Specimen centrifugation duration SpecCentrifugationDur The duration related to centrifugation The duration related to centrifugatio Speed and duration of centrifugation Numeric Values

In G force or speed and name centrifugation

Adult;Pediatric Supplemental 1.00 2017-04-17 14:55:46.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

second
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 participant/subject? Blood, specify type;CSF, complete the following;Urine;Saliva;Other, specify Blood, specify type;CSF, complete the following;Urine;Saliva;Other, specify Alphanumeric

Choose only one specimen type per CRF. If more than one specimen type collected, additional form(s) should be completed.

Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-06 11:44:03.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers 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 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

Free-Form Entry

C56064 Medication adjustment 5 half life text MedAdjust5HalfLifeTxt Text describing any medications that have been adjusted or taken within 5 half lives of the biomarkers being assessed Text describing any medications that have been adjusted or taken within 5 half lives of the biomarkers being assesse Indicate any medications that have been adjusted or taken within 5 half lives of the biomarkers being assessed Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 10:27:13.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

Free-Form Entry

C56140 Assay sensitivity specificity value AssaySensSpecVal The value of the assay sensitivity and specificity The value of the assay sensitivity and specificit Assay sensitivity and specificity Numeric Values Adult;Pediatric Exploratory 1.00 2017-06-06 13:43:49.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C15627 Pregnancy gestational week value PregGestatnlWkVal Participant/subject's current number of gestational day(s) or week(s) Participant/subject's current number of gestational day(s) or week(s) If Yes specify number of gestational weeks Alphanumeric

To be answered for women only

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

Free-Form Entry

C56087 Recreational substance dose RecSubstanceDose The dose of the recreational substance the participant uses The dose of the recreational substance the participant use Dose Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:11:53.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56151 Last cigarette smoked before sample collection time LastCigSmokeBefSampCollTime The time since the participant last smoked a cigarette before sample collection The time since the participant last smoked a cigarette before sample collectio Provide time since last cigarette was smoked before smaple collection Date or Date & Time Adult;Pediatric Supplemental 1.00 2017-06-06 15:44:04.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

C55009 Specimen storage temperature value SpecStorTempVal The temperature value for the specimen being stored The temperature value for the specimen being store Storage temperature Numeric Values

Please specify

Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-04-17 15:19:20.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

degrees celsius
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 Platelet-free plasma;Platelet-rich plasma;Serum Alphanumeric

Choose one

Adult;Pediatric Supplemental 1.00 2017-06-06 12:00:52.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56123 Specimen centrifugation performed indicator SpecCentrifPerfrmdInd The indicator relating to whether centrifugation was performed on the specimen The indicator relating to whether centrifugation was performed on the specime Was centrifugation performed? No;Yes;Unknown No;Yes;Unknown Alphanumeric Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-06 13:23:19.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56067 Participant current smoker indicator ParticCurrentSmokeInd The indicator relating to whether the participant is a current smoker The indicator relating to whether the participant is a current smoke Is participant a current smoker? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 10:34:31.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56141 Assay upper detection limit value AssayUpprDetectLimVal The value of the upper limit of detection of the assay The value of the upper limit of detection of the assa Upper limit of detection of assay Numeric Values Adult;Pediatric Exploratory 1.00 2017-06-06 13:46:27.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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moles over liters
C15629 Postpartum indicator PstpartmInd Whether the participant/subject is currently in her postpartum phase, after pregnancy phase, of pregnancy Whether the participant/subject is currently in her postpartum phase, after pregnancy phase, of pregnanc Is the participant/subject currently postpartum? Yes;No;Unknown Yes;No;Unknown Alphanumeric

To be answered for women only

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56088 Recreational substance quantity value RecSubstanceQuanVal The value representing the quantity of the recreational substance the participant uses The value representing the quantity of the recreational substance the participant use Quantity Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 11:14:16.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C55357 Microdialysis cerebral analyte glucose measurement MicrodiaCrbrlAnalytGluMeasr The value of glucose in in the cerebral microdialysis analyte The value of glucose in in the cerebral microdialysis analyte Glucose Numeric Values

Include units

Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

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/subjec Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 12:06:04.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 500

Free-Form Entry

CSV