CDE Detailed Report

Disease: Headache
Sub-Domain: Laboratory Tests and Biospecimens/Biomarkers
CRF: Biospecimens Collection and Processing

Displaying 1 - 50 of 84
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
C15977 Headache end date and time HdchEndDateTime The time of the day the headache ended The time of the day the headache ended Time at the end of first headache Date or Date & Time

Date and time

Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56095 CSF time collection storage interval CSFTimeCollStorIntrvl The interval between the time CSF was collected and stored. The interval between the time CSF was collected and stored. CSF 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
C56144 Inter assay variability value InterAssayVarVal The value representing inter assay variability The value representing inter assay variability Inter assay variability Numeric Values Adult;Pediatric Exploratory 1.00 2017-06-06 13:49:37.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56053 Sample obtain with headache indicator SampObtWithHeadacheInd The indicator relating to the sample being obtained while the participant was having a headache. The indicator relating to the sample being obtained while the participant was having a headache. Was sample obtained while the participant was having a headache? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 10:07:58.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56111 Specimen centrifugation speed value SpecCentrSpeedVal The speed at which the specimen was centrifuged. The speed at which the specimen was centrifuged. Speed and duration of centrifugation Numeric Values

In G force or speed and name centrifugation

Adult;Pediatric Supplemental 1.00 2017-06-06 12:11:18.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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G force
C12779 Test assay perform date TestAssyPerfrmDate Date the confirmatory diagnostic test or assay was performed Date the confirmatory diagnostic test or assay was performed Date and time of assay time Date or Date & Time Adult;Pediatric Exploratory 3.00 2013-07-24 21:00:23.88 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56077 Prescription medication dose PrescripMedDose The dose of the participant's prescription medication. The dose of the participant's prescription medication. Dose Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 10:57:43.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56128 Other processing method performed text OthrProcMethPerfrmdTxt Text specifying any other processing methods that were performed. Text specifying any other processing methods that were performed. Yes, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 13:30:51.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C16174 Menopause indicator MenopauseInd Indicates whether participant/subject is currently menopausal. Indicates whether participant/subject is currently menopausal. Is the participant/subject perimenopausal? 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

C56096 Drink fluid last date and time DrinkFluidLastDateTIme The date and time the participant last drank fluids The date and time the participant last drank fluids Date and time the participant last ate or drank fluids Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

Adult;Pediatric Supplemental 1.00 2017-06-06 11:35:36.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56145 Assay result type AssayResltTyp The results obtained from the assay. The results obtained from the assay. Results of assay Abnormal;Normal;Clinically Significant;Unknown;Other, specify Abnormal;Normal;Clinically Significant;Unknown;Other, specify Alphanumeric

Choose one

Adult;Pediatric Exploratory 1.00 2017-06-06 13:53:40.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56056 Sample collection headache diagnosis text SampCollHeadDiagnosTxt Text describing the headache diagnosis at the time of sample collection Text describing the headache diagnosis at the time of sample collection What was the headache diagnosis at the time of sample collection? Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 10:14:46.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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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 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

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C15604 Headache severity prior sample collection score HeadachSevrPriorSampCollctnScr The score rating of the severity of the participant/subject's last headache prior to sample collection The score rating of the severity of the participant/subject's last headache prior to sample collection Record severity of last headache prior to sample collection on a scale of 0-10 0;1;2;3;4;5;6;7;8;9;10 0 (Least severe);1;2;3;4;5;6;7;8;9;10 (Most severe) Numeric Values

0 = least severe; 10 = most severe

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

C56079 Prescription medication quantity value PrescripMedQuanVal The value representing the quantity of the participant's prescription medication. The value representing the quantity of the participant's prescription medication. Quantity Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 10:59:40.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56129 Specimen frozen indicator SpecFroznInd The indicator relating to whether the specimen was frozen. The indicator relating to whether the specimen was frozen. Was the specimen frozen? Yes;No (Skip to next section);Unknown (Skip to next section) Yes;No (Skip to next section);Unknown (Skip to next section) Alphanumeric Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-06 13:32:05.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C16177 Post-menopausal indicator PostMnpslInd Indicates whether participant/subject 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 CSF blood collected and stored. 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
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 assay. 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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C56057 Headache ictal indicator HeadacheIctalInd The indicator relating to whether the headache was ictal. The indicator relating to whether the headache was ictal. 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 specimen. 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

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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 collection. 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 supplements. 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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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-thawed. 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

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 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 storage. 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

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degrees Celsius
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 collection. 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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C56059 Headache 28 day prior to sample collection frequency Headache28DayPriSampCollFreq The frequency of the participant's headaches during the 28 days prior to sample collection The frequency 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 1.00 2017-06-06 10:17:46.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

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 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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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 phase. 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 supplements. 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

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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 sample. 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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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 having. 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

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

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C56100 CSF time storage analysis interval CSFTimeStorAnaIntrvl The interval of time between CSF storage and analysis. The interval of time between CSF storage and analysis. 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

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minute
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 collection. 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

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

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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 supplements. 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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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 in. 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

C56149 Headache treatment type HeadacheTreatmtTyp The type of treatment for the participant's headache. The type of treatment for the participant's headache. 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 centrifuge. 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

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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 analysis. 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
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 sample. 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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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 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

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 uses. 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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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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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 treatment. 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

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C55005 Specimen centrifugation duration SpecCentrifugationDur The duration related to centrifugation. The duration related to centrifugation. 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

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second
CSV