CDE Detailed Report

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

Displaying 51 - 84 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 / 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
C56075 Alcoholic drink consume past week count AlcDrinkConsPastWkCt The number of alcoholic drinks that were consumed within the past week. The number of alcoholic drinks that were consumed within the past week. Specify how man alcoholic drinks were consumed in the past week Numeric Values

In units

Adult;Pediatric Supplemental 1.00 2017-06-06 10:44:05.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C56127 Other processing method performed indicator OthrProcMethPerfrmdInd The indicator relating to whether any other processing methods were performed. The indicator relating to whether any other processing methods were performed. Were any other processing methods performed? No;Yes, specify;Unknown No;Yes, specify;Unknown Alphanumeric

If yes, specify

Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-06 13:29:38.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

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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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
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
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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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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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

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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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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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

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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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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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
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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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

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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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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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
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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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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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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CSV