CDE Detailed Report

Disease: Headache
Subdomain Name: 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 / 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
C16174 Menopause indicator MenopauseInd Indicates whether participant is currently menopausal Indicates whether participant/subject is currently menopausa 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

Free-Form Entry

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

Free-Form Entry

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 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

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 medicatio 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

Free-Form Entry

C56129 Specimen frozen indicator SpecFroznInd The indicator relating to whether the specimen was frozen The indicator relating to whether the specimen was froze 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

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

Free-Form Entry

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

Free-Form Entry

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

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

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

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

Free-Form Entry

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
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

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

Free-Form Entry

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

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

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
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

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

Free-Form Entry

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

Free-Form Entry

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

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

Free-Form Entry

minute
CSV