CDE Detailed Report

Disease: Headache
Subdomain Name: Laboratory Tests and Biospecimens/Biomarkers
CRF: Biospecimens Collection and Processing

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
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

Free-Form Entry

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
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

Free-Form Entry

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

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

Free-Form Entry

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

Free-Form Entry

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

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

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

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

Free-Form Entry

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

Free-Form Entry

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

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

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

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

Free-Form Entry

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

Free-Form Entry

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

C56071 Cigarette smoked past week count CigSmokePastWkCt The number of cigarettes the participant has smoked in the past week The number of cigarettes the participant has smoked in the past wee If yes, specify how many cigarettes were smoked in the past week Numeric Values

Include units

Adult;Pediatric Supplemental 1.00 2017-06-06 10:37:56.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

C56125 Centrifugation substance added before after indicator CentriSubstncAddedBefAftInd The indicator relating to whether any substances were added before or after centrifugation The indicator relating to whether any substances were added before or after centrifugatio If yes, were there any substances added before or after centrifguation? No;Yes, specify;Unknown No;Yes, specify;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 13:24:51.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56142 Assay lower detection limit value AssayLowrDetectLimVal The value of the lower limit of detection of the assay The value of the lower limit of detection of the assa Lower 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

Free-Form Entry

moles over liters
C15630 Postpartum day week value PstpartmDayWkVal Number of days/weeks the participant/subject has been postpartum Number of days/weeks the participant/subject has been postpartum If Yes, specify number of days weeks the participant subject is postpartum Numeric Values

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

Free-Form Entry

C56091 Postmenopausal last menstruation date PostmenLastMenstrDate The date of the participant's last menstruation if she is postmenopausal The date of the participant's last menstruation if she is postmenopausa If postmenopausal, specify date of last menstruation Date or Date & Time

To be answered for women only

Adult;Pediatric Supplemental 1.00 2017-06-06 11:18:22.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

C55382 Medication prescription type text MedicationPrescriptionTypTxt The free-text field related to type of prescription medication participant/subject The free-text field related to type of prescription medication participant/subjec Name Alphanumeric Adult;Pediatric Supplemental 1.00 2017-05-02 09:31:44.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

Free-Form Entry

C56108 CSF specimen opening pressure value CSFCollOpenPresVal The value of the opening pressure of the CSF specimen collected The value of the opening pressure of the CSF specimen collecte Opening pressure Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-06 12:08:24.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

C01701 Lab specimen collection date and time LabSpecmnCollDateTime Date (and time if applicable and known) when the specimen was collected Date (and time if applicable and known) when the specimen was collected Date and time of specimen collection 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.).

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

2004004
C56072 Cigarette smoked past week unit of measure CigSmokePastWkUnitMeasr The unit of measure pertaining to the amount of cigarettes the participant has smoked in the past week The unit of measure pertaining to the amount of cigarettes the participant has smoked in the past wee If yes, specify how many cigarettes were smoked in the past week Individual;Pack;Carton Individual;Pack;Carton Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 10:41:36.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56126 Centrifugation substance added before after text CentriSubstncAddedBefAftTxt Text specifying the substance(s) added before or after centrifugation Text specifying the substance(s) added before or after centrifugatio Yes, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-06 13:26:49.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

Free-Form Entry

C56143 Intra assay variability value IntraAssayVarVal The value representing intra assay variability The value representing intra assay variability Intra 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

Free-Form Entry

C15632 Premenarchal indicator PremenarchlInd Whether the participant/subject is currently premenarchal, the period before a female's first menstrual cycle Whether the participant/subject is currently premenarchal, the period before a female's first menstrual cycl Is the participant/subject premenarchal? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Complete for Pediatric-studies ONLY

No references available 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

C56093 Specimen collected for biomarker indicator SpecCollBiomarkInd The indicator relating to whether the participant had any specimen(s) collected for biomarkers The indicator relating to whether the participant had any specimen(s) collected for biomarker Did the subject/participant have any specimen(s) collected for biomarkers? Yes;No;Unknown Yes;No(STOP);Unknown(STOP) Alphanumeric

If there was no specimen collected for biomarkers or it is unknown that a specimen was collected for biomarkers, discontinue obtaining information from participant/subject.

Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-06 11:30:38.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C56043 Headache migraine onset time HeadMigOnsetTime The time that the subject's headache started The time that the subject's headache starte Time at onset of first headache following specimen obtained Date or Date & Time Adult;Pediatric Exploratory 1.00 2017-06-05 14:58:03.0 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

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

Free-Form Entry

milliliter
C10821 Food last consumed date and time FoodLstConsmDateTime Date (and time, if applicable and known) the participant/subject last ate food Date (and time, if applicable and known) the participant/subject last ate food 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.).

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 Biospecimens Collection and Processing Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Free-Form Entry

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 wee 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

Free-Form Entry

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 performe 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

Free-Form Entry

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

Free-Form Entry

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 store 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

Free-Form Entry

minute
CSV