CDE Detailed Report
Disease: cookie-policy
Sub-Domain: Additional Proposed Instruments
CRF:

491 results.
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 Source Form Set Form Field Domain CDASH Variable CDASH Definition CDASH Label Controlled Terminology Prompt Essentiality Question Text CDASH imp guidance SDTM IG target csDSR PhenX Data Type CRF Completion Inst SDTMIG Target Var SDTMIG Target Map Codelist Name PVs Pre Pop Value Query Display List Style
C55779 Imaging automated evaluation vascular MRI data indicator ImagAutoEvalVasMRIDataInd The indicator relating to whether or not an automated evaluation of vascular magnetic resonance imaging (MRI) data has been given. The indicator relating to whether or not an automated evaluation of vascular magnetic resonance imaging (MRI) data has been given. No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2017-05-31 12:26:23.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C02016 Medication prior or concomitant start date and time MedctnPriorConcomStrtDateTime The date (and time, if applicable and known) on which the prior/concomitant medication usage began. The date (and time, if applicable and known) on which the prior/concomitant medication usage began. Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

3162752 DeBaun Forms
C17409 Visit date VisitDate Date of interview or visit (actually the date when data in the form were captured) Date of interview or visit Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

DeBaun Forms LB VISDAT

Visit Date

Visit Date

What [is/was] the date of the visit?

N/A Char Record the [date/start date] of the visit using DD-MON-YYYY format. Prompt
C13234 National Institutes of Health Stroke Scale (NIHSS) - Level of consciousness tertiary question score NIHSSLvlConscTertryQScore Level of consciousness (LOC) commands assessed using the NIH Stroke Scale (NIHSS) Level of consciousness (LOC) commands assessed using the NIH Stroke Scale (NIHSS) 0;1;2;0;1;2;0;1;2 Performs both tasks correctly.;Performs one task correctly;Performs neither task correctly;Performs both tasks correctly.;Performs one task correctly;Performs neither task correctly;Performs both tasks correctly.;Performs one task correctly;Performs neither task correctly Numeric values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C19840 Medical history medication change since last visit indicator MedHistMedctnChngeSLVInd Indicator of medication changes since last study visit Indicator of medication changes since last study visit No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C14006 Imaging stenosis percentage value ImgStenosisPercentageVal Indicates stenosis percentage value Indicates stenosis percentage value Numeric Values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

0 99 percent
C56420 Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) - Examinee visual hearing aid glasses used indicator WASIIIExVisHearAidGlassUsedInd The indicator relating to whether the examine used his/her glasses during testing, as part of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II). The indicator relating to whether the examine used his/her glasses during testing, as part of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II). Used;Not used Used;Not used Alphanumeric Adult;Pediatric Supplemental 1.00 2017-06-12 11:53:18.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C08254 Imaging visual analysis location performed type ImgVisAnlysisLocPerfTyp Location where visual analysis of the imaging data are performed Location where visual analysis of the imaging data are performed Central;Central read;Local - Site;Local read;Local report;Other, specify Central;Central read;Local - Site;Local read;Local report;Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C13904 Imaging interpretation offsite media type ImgInterpretOffsiteMediaTyp Indicates imaging offsite media type Indicates imaging offsite media type Video;Print;Digital Video;Print;Digital Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C13915 Imaging plaque thickness measurement ImgPlaqThicknessMeasr Indicates plaque thickness Indicates plaque thickness Numeric Values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

C54609 Brief Test of Executive Function Second Edition (BRIEF 2) - Emotional control total raw scale score BRIEF2EmtnlCntrlTtlRwSclScore Total score of the raw scale for the emotional control function, as part of the Brief Test of Executive Function Second Edition (BRIEF 2) Total score of the raw scale for the emotional control function, as part of the Brief Test of Executive Function Second Edition (BRIEF 2) Numeric Values Adult;Pediatric Supplemental 1.00 2017-03-22 09:57:02.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

C01013 Physical exam description text PhysExamDescripTxt Free text field to describe the abnormality in a specific body system or an explanation of why the body system was not examined Free text field to describe the abnormality in a specific body system or an explanation of why the body system was not examined Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other 255

Free-Form Entry

2201880 DeBaun Forms
C14679 Pediatric Migraine Disability Assessment (MIDAS) - headache school partial absence day count PedMIDASHeadSchPrtlAbseDayCt Count missed partial school days in the last 3 months due to headaches, as part of migraine disability assessment (MIDAS) questionnaire-pediatric form. Count missed partial school days in the last 3 months due to headaches, as part of migraine disability assessment (MIDAS) questionnaire-pediatric form. Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

0 92
C12497 Imaging cerebellum abnormality type ImgCrblmAbnrmlyTyp The type of abnormality in the cerebellum on the image The type of abnormality in the cerebellum on the image Other, specify;Cleft;Vermal hypoplasia;Hemispheric hypoplasia;Vermal dysplasia;Hemispheric dysplasia;Cysts Other, specify;Cleft;Vermal hypoplasia;Hemispheric hypoplasia;Vermal dysplasia;Hemispheric dysplasia;Cysts Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Multiple Pre-Defined Values Selected

C18888 Imaging acquisition reason other text ImgAcquisitionRsnOTH The free-text field related to 'Imaging acquisition reason' specifying other text. Describes why the imaging study was performed The free-text field related to 'Imaging acquisition reason' specifying other text. Describes why the imaging study was performed Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other 4000

Free-Form Entry

C13947 Imaging peak velocity measurement ImgPeakVelocityMeasr Indicates peak velocity measurement (cm/sec) Indicates peak velocity measurement (cm/sec) Numeric Values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

0 999 centimeter per second
C56388 Conners Continuous Performance Test 3rd Edition (CPT3) - Impulsivity commission count ConnersCPT3ImpCommCt The number of incorrect responses to non-targets, as part of the Conners Continuous Performance Test 3rd Edition (CPT3). The number of incorrect responses to non-targets, as part of the Conners Continuous Performance Test 3rd Edition (CPT3). Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-09 15:38:27.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

0
C02311 Adverse event MedDRA lower level term code AdvsEvntMedDRALowerLvlTermCode Code that corresponds to the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) for an adverse event Code that corresponds to the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) for an adverse event Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other 255

Free-Form Entry

3133353 DeBaun Forms
C17528 Friedreich's Ataxia Rating Scale (FARS) - neurological exam peripheral deep tendon reflex brachioradialis jerk right score FARSPNSNeuExDTenRefBrJRtScore Score for right-side brachioradialis jerk in the peripheral nervous system section of the neurological exam, as part of the Friedreich's Ataxia Rating Scale (FARS). Score for right-side brachioradialis jerk in the peripheral nervous system section of the neurological exam, as part of the Friedreich's Ataxia Rating Scale (FARS). 0;1;2;3;4;0;1;2;3;4;0;1;2;3;4 0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia;0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia;0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C13882 Magnetic resonance angiography type MRAngioTyp The type as related to magnetic resonance angiography (MRA) The type as related to magnetic resonance angiography (MRA) TOF;Head;Neck;Contrast enhanced Head and Neck;Magnetic resonance venography (MRV) with contrast;Magnetic resonance venography (MRV) without contrast;Computer Tomography Venography (CTV) Time of Flight;Head;Neck;Contrast enhanced Head and Neck;Magnetic resonance venography (MRV) with contrast;Magnetic resonance venography (MRV) without contrast;Computer Tomography Venography (CTV) Alphanumeric Adult;Pediatric Supplemental 4.00 2017-04-11 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Multiple Pre-Defined Values Selected

C13245 National Institutes of Health Stroke Scale (NIHSS) - Severity total score NIHSSSevTotalScore The level of stroke severity as measured by the NIH Stroke Scale (NIHSS) scoring system (i.e., total of the subscale item scores). The level of stroke severity as measured by the NIH Stroke Scale (NIHSS) scoring system (i.e., total of the subscale item scores). Numeric Values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

0 42
C21486 Wechsler Adult Intelligence Scale IV (WAIS IV) - Digit span forward subtest trial number WAISIVDSFTrialNum Trial number, as part of Wechsler Adult Intelligence Scale IV (WAIS IV) Digit Span Forward subtest Trial number, as part of Wechsler Adult Intelligence Scale IV (WAIS IV) Digit Span Forward subtest 1;2 Trial 1;Trial 2 Numeric Values Adult;Pediatric Supplemental 1.00 2015-07-22 11:32:44.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C14017 Microembolic signal unidirectional indicator MicroembolSignalUnidirectInd Indicates unidirectional microembolic signal Indicates unidirectional microembolic signal Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C56431 Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) - Perceptual Reasoning confidence interval lower bound value WASIIIPercRsngConfIntrvlLowVal The lower bound of the subject's Perceptual Reasoning confidence interval, as part of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II). The lower bound of the subject's Perceptual Reasoning confidence interval, as part of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II). Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-12 12:55:22.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

C10931 Imaging quality of images technically satisfactory indicator ImgQualImgTechnSatisInd Indicator of whether the quality of the images were technically satisfactory. Indicator of whether the quality of the images were technically satisfactory. Yes;No;Unknown;Not applicable Yes;No;Unknown;Not applicable Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C12476 Imaging other incidental finding indicator ImgOthrIncidentalFindInd Indicator of whether other incidental findings are found within the image studies Indicator of whether other incidental findings are found within the image studies Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C18610 Imaging in plane resolution axis 2 measurement ImgInPlaneRsltnAxis2Measr Axis 2 of in-plane spatial resolution used in imaging acquisition Axis 2 of in-plane spatial resolution used in imaging acquisition Numeric Values Adult;Pediatric Supplemental 1.00 2013-09-12 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

millimeter
C13926 Intima media thickness (IMT) B mode indicator IMTBModeInd Indicates intima media thickness (IMT) B mode Indicates intima media thickness (IMT) B mode Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C54692 PROMIS - Global Health carry out social role scale PROMISGlbHlthCrryOutSocRlScl Scale related to an individual's rating of his/her ability to carry out usual social activities and roles, as part of the PROMIS Global Health Scale related to an individual's rating of his/her ability to carry out usual social activities and roles, as part of the PROMIS Global Health 1;2;3;4;5;1;2;3;4;5 Excellent;Very good;Good;Fair;Poor;Excellent;Very good;Good;Fair;Poor Alphanumeric Adult;Pediatric Supplemental 1.00 2017-04-07 15:34:25.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C01559 Arterial partial pressure carbon dioxide value ArterialPPCO2Val Measurement of how much carbon dioxide is dissolved in the arterial blood and how well carbon dioxide is able to move out of the body (PaCO2) Measurement of how much carbon dioxide is dissolved in the arterial blood and how well carbon dioxide is able to move out of the body (PaCO2) Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

0 100 millimeter of mercury
C15561 Imaging angiography contrast enhanced text ImgAngioContrastEnhancTxt If contrast enhanced in angiography, specify the method If contrast enhanced in angiography, specify the method Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other 255

Free-Form Entry

C13147 Stroke Specific Quality of Life Scale (SS-QOL) - trouble phone language scale SSQOLTroubPhonScale The scale for trouble speaking on phone based on Stroke Specific Quality of Life Scale (SS-QOL). The scale for trouble speaking on phone based on Stroke Specific Quality of Life Scale (SS-QOL). 1;2;3;4;5;1;2;3;4;5 Total help - Couldn't do it at all - Strongly agree;A lot of help - A lot of trouble - Moderately agree;Some help - Some trouble - Neither agree nor disagree;A little help - A little trouble - Moderately disagree;No help needed - No trouble at all - Strongly disagree;Total help - Couldn't do it at all - Strongly agree;A lot of help - A lot of trouble - Moderately agree;Some help - Some trouble - Neither agree nor disagree;A little help - A little trouble - Moderately disagree;No help needed - No trouble at all - Strongly disagree Numeric values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C19151 Discontinuation date DiscontinuationDate The date of discontinuation The date of discontinuation Date or Date & Time Adult;Pediatric Supplemental 1.00 2014-05-29 11:10:46.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

DeBaun Forms
C56440 Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) - Full Scale IQ 2 confidence interval lower bound value WASIIIFullSclIQ2ConfIntLowVal The lower bound of the subject's Full Scale IQ-2 confidence interval, as part of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II). The lower bound of the subject's Full Scale IQ-2 confidence interval, as part of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II). Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-12 13:06:29.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

C13958 Microembolic signal settings type MicroembolSignalSettingTyp Indicates microembolic signal settings category Indicates microembolic signal settings category Leading cols;Trailing cols;Threshold;Rejection Leading cols;Trailing cols;Threshold;Rejection Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C56409 Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) - Similarities raw score WASIIISimRawScore The raw score that the subject received on the Similarities subtest of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) . The raw score that the subject received on the Similarities subtest of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II). Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-12 11:23:35.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

0 45
C08147 Data source DataSource Source of the data provided on the case report form Source of the data provided on the case report form Participant/subject;Mother;Father;Sister;Brother;Son;Daughter;Family, specify relation;Friend;Physician;Chart/Medical record;Other, specify;Unknown;Spouse Participant/subject;Mother;Father;Sister;Brother;Son;Daughter;Family, specify relation;Friend;Physician;Chart/Medical record;Other, specify;Unknown;Spouse Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-20 10:46:24.96 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Multiple Pre-Defined Values Selected

DeBaun Forms
C13894 Imaging vessel angiography overall assessment type ImgVesselAngioOverallAssmTyp Indicates vessel angiography overall assessment Indicates vessel angiography overall assessment Normal;Small Caliber;Impaired flow Normal;Small Caliber;Impaired flow Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C13463 Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003) - cognitive or behavioral deficit description text PSOMSNECogBehavDeficitDescTxt Description of the cognitive or behavioral deficits observed in the participant/subject based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). Description of the cognitive or behavioral deficits observed in the participant/subject based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other 255

Free-Form Entry

DeBaun Forms
C21497 Wechsler Adult Intelligence Scale IV (WAIS IV) - Digit span backward subtest last trial correct digit score WAISIVLDSBScore Score for correctly recalled digits for the last trial, as part of Wechsler Adult Intelligence Scale IV (WAIS IV) Digit Span Backward subtest Score for correctly recalled digits for the last trial, as part of Wechsler Adult Intelligence Scale IV (WAIS IV) Digit Span Backward subtest Numeric Values Adult;Pediatric Supplemental 1.00 2015-07-22 11:32:44.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

0 8
C14029 Vasospasm posterior ratio result VasoPosterRatioReslt Indicates vasospasm posterior ratio result Indicates vasospasm posterior ratio result Numeric Values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

0 10
491 results.
CSV