CDE Detailed Report
Disease: general-data-protection-regulation-gdpr
Sub-Domain: Assessments and Examinations
CRF:

84 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
C12485 Imaging other cortical abnormality indicator ImgOthrCorticalAbnrmlyInd Indicator of whether other cortical abnormalities of the brain are present Indicator of whether other cortical abnormalities of the brain are present Other cortical abnormality Yes;No Yes;No Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Single Pre-Defined Value Selected

C18715 Imaging radio frequency coil other text ImgRFCoilOTH The free-text field related to 'Imaging radio frequency coil type' specifying other text. Type of radio frequency (RF) coil(s) used for the body part scanned The free-text field related to 'Imaging radio frequency coil type' specifying other text. Type of radio frequency (RF) coil(s) used for the body part scanned Other, specify Alphanumeric

Choose all that apply

No references available Adult;Pediatric Supplemental ? Highly Recommended 1.00 2014-05-27 13:34:46.0 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics 4000

Free-Form Entry

C08239 Imaging echo duration ImgEchoDur Duration between the application of the 90 degree pulse and the peak of the echo signal, in milliseconds, during the spin echo and inversion recovery pulse sequences in imaging acquisition Duration between the application of the 90° pulse and the peak of the echo signal, in milliseconds, during the spin echo and inversion recovery pulse sequences in imaging acquisition Echo time ET Numeric Values

To be answered for each sequence used for MRI. Answer should be recorded in milliseconds (ms)

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Free-Form Entry

millisecond
C12496 Imaging cerebellum abnormal indicator ImgCrblmAbnrmlInd Indicator as to whether the cerebellum appears normal or abnormal in the image studies Indicator as to whether the cerebellum appears normal or abnormal in the image studies Cerebellum Abnormal;Normal;Abnormal;Normal Abnormal;Normal;Abnormal;Normal Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Single Pre-Defined Value Selected

C18859 Imaging cerebellum abnormality other text ImgCrblmAbnrmlyOTH The free-text field related to 'Imaging cerebellum abnormality type' specifying other text. The type of abnormality in the cerebellum on the image The free-text field related to 'Imaging cerebellum abnormality type' specifying other text. The type of abnormality in the cerebellum on the image Other, specify Alphanumeric

Only answered if Abnormal is answered for "Cerebellum"

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics 4000

Free-Form Entry

C10682 Imaging anatomic site ImgAntmicSite Type of body part or anatomy scanned in the imaging study Type of body part or anatomy scanned in the imaging study Body part scanned Brain;Cervical spine;Thoracic spine;Lumbar spine Brain;Cervical spine;Thoracic spine;Lumbar spine Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Multiple Pre-Defined Values Selected

C12475 Imaging magnetic resonance imaging T1 T2 sequence name ImgMRIT1T2SeqName The name of the T1 or T2 sequences used for Magnetic Resonance Imaging (MRI) The name of the T1 or T2 sequences used for MRI Specify sequence name of T1 or T2 used Alphanumeric No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics 4000

Free-Form Entry

C14964 Sedation used indicator SedationUsedInd Whether the participant/subject was administered any sedation Whether the participant/subject was administered any sedation Was sedation used? Yes;No Yes;No Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-14 19:48:50.273 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Single Pre-Defined Value Selected

C12486 Imaging other cortical abnormality type ImgOthrCorticalAbnrmlyTyp The type of other cortical abnormality The type of other cortical abnormality If yes specify Schizencephaly;Porencephaly;Other, specify Schizencephaly;Porencephaly;Other, specify Alphanumeric

Only answered if Yes is answered for "Other cortical abnormality"

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Multiple Pre-Defined Values Selected

C18716 Imaging scanner manufacturer other text ImgScannerManufOTH The free-text field related to 'Imaging scanner manufacturer name' specifying other text. Name of manufacturer of imaging scanner The free-text field related to 'Imaging scanner manufacturer name' specifying other text. Name of manufacturer of imaging scanner Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental ? Highly Recommended 1.00 2014-05-27 13:34:46.0 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics 4000

Free-Form Entry

C08241 Imaging field of view axis 1 measurement ImgFieldViewAxis1Measr Axis 1 of the image that is visible through the camera at a particular position in orientation and space in millimeters Axis 1 of the image that is visible through the camera at a particular position in orientation and space in millimeters Field of view, axis 1 Numeric Values

To be answered for each sequence used for MRI. Answer should be recorded as a dimension (AAxAA) and in millimeters squared (mm2)

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-25 08:54:08.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Free-Form Entry

millimeter
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 If Abnormal specify 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

Only answered if Abnormal is answered for "Cerebellum"

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Multiple Pre-Defined Values Selected

C18860 Imaging gray matter hyperintensity T2 fluid attenuated inversion recovery other text ImgGryMtrHyperT2FLAIRSiteOTH The free-text field related to 'Imaging gray matter hyperintensity T2 fluid attenuated inversion recovery site' specifying other text. The type of anatomical site of the grey matter hyperintensity on T2/FLAIR (fluid attenuated inversion recovery) images The free-text field related to 'Imaging gray matter hyperintensity T2 fluid attenuated inversion recovery site' specifying other text. The type of anatomical site of the grey matter hyperintensity on T2/FLAIR (fluid attenuated inversion recovery) images Other, specify Alphanumeric

Only answered if Yes is answered for "Grey matter hyperintensity on T2/FLAIR images"

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics 4000

Free-Form Entry

C10685 Imaging slice orientation type ImgSliceOrientTyp The slice orientation used in imaging acquisition The slice orientation used in imaging acquisition Slice Orientation Axial;Coronal;Sagittal;Oblique Axial;Coronal;Sagittal;Oblique Alphanumeric

To be answered for each sequence used for MRI

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

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 Other incidental findings Yes;No Yes;No Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Single Pre-Defined Value Selected

C17402 Site name SiteName The name of the site for the study The name of the site for the study Where Performed Alphanumeric No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-06-21 00:00:00.0 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics 255

Free-Form Entry

C12487 Imaging other cortical abnormality site type ImgOthrCorticalAbnrmlySiteTyp The anatomical site(s) of the other cortical abnormality The anatomical site(s) of the other cortical abnormality If yes indicate locations Temporal;Frontoparietal;Occipital Temporal;Frontoparietal;Occipital Alphanumeric

Only answered if Yes is answered for "Other cortical abnormality"

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Multiple Pre-Defined Values Selected

C18718 Imaging scanner strength other text ImgScannerStrgthOTH The free-text field related to 'Imaging scanner strength value' specifying other text. Value, in Tesla (T), of the scanner's magnetic field strength used for the scan being reported The free-text field related to 'Imaging scanner strength value' specifying other text. Value, in Tesla (T), of the scanner's magnetic field strength used for the scan being reported Other, specify Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental ? Highly Recommended 1.00 2014-05-27 13:34:46.0 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics 4000

Free-Form Entry

Tesla
C08242 Imaging acquisition duration ImgAcquisitionDur Duration of the imaging scan in minutes The duration of the imaging acquisition, in minutes Total time in scanner Numeric Values

Include all studies done within each particular session.

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Free-Form Entry

minute
C12498 Imaging white matter T2 abnormal indicator ImgT2WWMAbnrmlInd Indicator of whether the white matter appears normal or abnormal on T2 weighted images Indicator of whether the white matter appears normal or abnormal on T2 weighted images White matter on T2 weighted images Abnormal;Normal;Abnormal;Normal Abnormal;Normal;Abnormal;Normal Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Single Pre-Defined Value Selected

C10837 Imaging gap between slices measurement ImgGapBetwnSlicesMeasr Measurement of the gap between slices used in imaging acquisition Measurement of the gap between slices used in imaging acquisition Gap between slices Numeric Values

Answer should be recorded in millimeteres squared (mm) or % (for 2D acquisition)

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-25 08:54:08.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Free-Form Entry

millimeter
C12477 Imaging other incidental finding type ImgOthrIncidentalFindTyp The type of other incidental findings found within the image studies The type of other incidental findings found within the image studies If Yes indicate types PVL;Other white matter intensities;Venous malformations;Vascular malformations;Other, specify PVL;Other white matter intensities;Venous malformations;Vascular malformations;Other, specify Alphanumeric

Only answered if Yes is answered for "Other incidental findings"

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Multiple Pre-Defined Values Selected

C17798 Imaging contrast agent name ImgContrastAgentName Name of imaging contrast agent used Name of imaging contrast agent used If yes name of the contrast Alphanumeric No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-22 16:57:17.79 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics 4000

Free-Form Entry

C12488 Imaging subcortical cyst indicator ImgSubCorticalCystInd Indicator of whether subcortical cysts are found in the image studies Indicator of whether subcortical cysts are found in the image studies Subcortical cysts Yes;No Yes;No Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Single Pre-Defined Value Selected

C18719 Imaging slice orientation other text ImgSliceOrientOTH The free-text field related to 'Imaging slice orientation type' specifying other text. The slice orientation used in imaging acquisition The free-text field related to 'Imaging slice orientation type' specifying other text. The slice orientation used in imaging acquisition Other, specify Alphanumeric

To be answered for each sequence used for MRI

No references available Adult;Pediatric Supplemental ? Highly Recommended 1.00 2014-05-27 13:34:46.0 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics 4000

Free-Form Entry

C08244 Imaging slice thickness value ImgSliceThicknessVal Value of the thickness of the slice measured in millimeters (mm) Value of the thickness of the optical slice measured in millimeters (mm) Slice thickness Numeric Values

Answer should be recorded in millimeteres squared (mm)

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-25 08:54:08.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Free-Form Entry

0 99 millimeter
C12499 Imaging T2 weighted white matter abnormality site type ImgT2WWMAbnrmlySiteTyp The type of anatomical site of the white matter abnormality on T2 weighted images The type of anatomical site of the white matter abnormality on T2 weighted images If Abnormal indicate locations Frontal;Parietal;Temporal;Cerebellar WM;Deep WM;Diffuse;Occipital;Periventricular Frontal;Parietal;Temporal;Cerebellar WM;Deep WM;Diffuse;Occipital;Periventricular Alphanumeric

Only answered if Abnormal is answered for "White matter on T2 weighted images"

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-25 08:54:08.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Multiple Pre-Defined Values Selected

C10927 Imaging inversion time ImgInversionTime The time period between the 180° inversion pulse and the 90° excitation pulse in an Inversion Recovery pulse sequence. The time period between the 180° inversion pulse and the 90° excitation pulse in an Inversion Recovery pulse sequence. Inversion Time TI Numeric Values

If the sequences are different for T1 and FLAIR sequence parameters, record the FLAIR parameters as indicated. If they are the same, leave the FLAIR parameters section blank

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-25 08:54:08.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Free-Form Entry

millisecond
C12478 Imaging cortex-pachygyria indicator ImgCortexPachygyriaInd Indicator of whether cortex-pachygyria are found within the image studies Indicator of whether cortex-pachygyria are found within the image studies Cortex Pachygria includes cobblestone lissencelphaly Yes;No Yes;No Alphanumeric

Includes cobblestons lissencephaly

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Single Pre-Defined Value Selected

C17925 Imaging contrast agent dose ImgContrastAgentDose Dosage of the contrast agent used Dosage of the contrast agent used dosage Alphanumeric No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics 4000

Free-Form Entry

C00008 Age value AgeVal Value for participant/subject's age, calculated as elapsed time since the birth of the participant/subject. Value for participant/subject's age, calculated as elapsed time since the birth of the participant/subject. Age of affected Numeric Values

This is recorded for each brain MRI performed. This is a derived field from Date of Birth and Visit Date.

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-08-28 16:08:00.453 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Free-Form Entry

0 1800 month DeBaun Forms
C12489 Imaging subcortical cysts site type ImgSubCorticalCystSiteTyp The anatomical site(s) of the subcortical cysts The anatomical site(s) of the subcortical cysts If Yes indicate locations Temporal;Frontoparietal;Occipital Temporal;Frontoparietal;Occipital Alphanumeric

Only answered if Yes is answered for "Subcortical cysts"

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-24 11:38:01.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Multiple Pre-Defined Values Selected

C18720 Imaging visual analysis location performed other text ImgVisAnlysisLocPerfOTH The free-text field related to 'Imaging visual analysis location performed type' specifying other text. Location where visual analysis of the imaging data are performed The free-text field related to 'Imaging visual analysis location performed type' specifying other text. Location where visual analysis of the imaging data are performed Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental ? Highly Recommended 1.00 2014-05-27 13:34:46.0 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics 4000

Free-Form Entry

C08245 Imaging slice count ImgSliceCt Count representing the total number of single image planes captured during imaging acquisition Count representing the total number of single image planes captured during imaging acquisition Number of slices Numeric Values

To be answered for each sequence used for MRI.

No references available Adult;Pediatric Supplemental ? Highly Recommended 3.00 2013-07-25 08:54:08.2 Brain Magnetic Resonance Imaging (MRI) Assessments and Examinations Imaging Diagnostics

Free-Form Entry

84 results.
CSV