Sub-Domain: general-data-protection-regulation-gdpr
CRF:
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 |
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C14467 | Sensory system abnormality symmetry type | SensySysAbnrmlySymmTyp | Symmetry of abnormality for sensory system results | Symmetry of abnormality for sensory system results | Symmetry of Abnormality | Symmetric;Asymmetric | Symmetric;Asymmetric | Alphanumeric |
Choose only one |
No references available | Adult;Pediatric | Proposed | 1.00 | 2012-10-05 00:00:00.0 | Neurological Exam | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C18946 | Reflex plantar left response other text | RflxPlntrLftRespnsOTH | The free-text field related to 'Reflex plantar left response result' specifying other text. The results from reflex plantar response on the left side | The free-text field related to 'Reflex plantar left response result' specifying other text. The results from reflex plantar response on the left side | Other, specify | Alphanumeric |
Choose all that apply. If other, explain. |
No references available | Adult;Pediatric | Proposed | 1.00 | 2012-10-05 00:00:00.0 | Neurological Exam | general-data-protection-regulation-gdpr | 4000 |
Free-Form Entry |
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C14442 | Muscle bulk assessment abnormality type | MuscBulkAbnrmlyAssmtTyp | The muscle bulk abnormality type | The muscle bulk abnormality type | If abnormal, indicate type: | Abnormal - Increased;Abnormal - Decreased;Other, specify | Abnormal - Increased;Abnormal - Decreased;Other, specify | Alphanumeric |
Choose one |
No references available | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Neurological Exam | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C18512 | Reflex right leg assessment status | RflxRtLegAssmtStatus | The status of the relfex assessment for the right leg. | The status of the relfex assessment for the right leg. | Right Leg | Increased with clonus;Increased without clonus;Hypoactive;Absent | Increased with clonus;Increased without clonus;Hypoactive;Absent | Alphanumeric | No references available | Adult;Pediatric | Proposed | 3.00 | 2013-07-30 14:29:49.047 | Neurological Exam | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C14454 | Cerebellar or coordination assessment type | CerbllrCoordinationAssmtTyp | Type of cerebellar/coordination assessment performed | Type of cerebellar/coordination assessment performed | Cerebellar/Coordination assessments | Finger-to-Nose;Rapid Alternating Movements;Heel-to-Shin | Finger-to-Nose;Rapid Alternating Movements;Heel-to-Shin | Alphanumeric |
For each assessment type record whether an abnormality is present and if so the type of abnormality |
No references available | Adult;Pediatric | Proposed | 1.00 | 2012-10-05 00:00:00.0 | Neurological Exam | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C18936 | Muscle tone assessment abnormality other text | MuscToneAbnrmlyAssmtOTH | The free-text field related to 'Muscle tone assessment abnormality type' specifying other text. The muscle tone abnormality type | The free-text field related to 'Muscle tone assessment abnormality type' specifying other text. The muscle tone abnormality type | Other, specify | Alphanumeric | No references available | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Neurological Exam | general-data-protection-regulation-gdpr | 4000 |
Free-Form Entry |
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C14432 | Mental status exam abnormality indicator | MentlStatExamAbnrmlyInd | Whether the mental assessment showed abnormal results | Whether the mental assessment showed abnormal results | Abnormality present? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Choose only one |
No references available | Adult;Pediatric | Proposed | 1.00 | 2012-10-05 00:00:00.0 | Neurological Exam | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C14468 | Sensory system abnormality anatomic site | SensySysAbnrmlySymmAntmicSite | The location of abnormality for sensory system | The location of abnormality for sensory system | Location of Abnormality | Stocking;Stocking/Glove;Dermatome;Sensory Nerve;Other, specify | Stocking;Stocking/Glove;Dermatome;Sensory Nerve;Other, specify | Alphanumeric |
Choose all that apply. If other, explain. |
No references available | Adult;Pediatric | Proposed | 1.00 | 2012-10-05 00:00:00.0 | Neurological Exam | general-data-protection-regulation-gdpr |
Multiple Pre-Defined Values Selected |
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C18947 | Sensory system global assessment other text | SensySysGlobAssmtOTH | The free-text field related to 'Sensory system global assessment result' specifying other text. The condition and ability of sensory system | The free-text field related to 'Sensory system global assessment result' specifying other text. The condition and ability of sensory system | Other, specify | Alphanumeric |
Choose one. If abnormal answer questions A-D. |
No references available | Adult;Pediatric | Proposed | 1.00 | 2012-10-05 00:00:00.0 | Neurological Exam | general-data-protection-regulation-gdpr | 4000 |
Free-Form Entry |
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C14443 | Muscle tone assessment anatomic site | MuscToneAssmtAntmicSite | Anatomic location of the muscle tone as part of the motor examination. | Anatomic location of the muscle tone as part of the motor examination. | Muscle Tone - global assessment | Right upper extremity;Left upper extremity;Right lower extremity;Left lower extremity;Truncal tone | Right upper extremity (RUE);Left upper extremity (LUE);Right lower extremity (RLE);Left lower extremity (LLE);Truncal tone | Alphanumeric |
Evaluate all extremities. Truncal tone - is recommended for pediatric studies only |
No references available | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Neurological Exam | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||
C18513 | Sensory system abnormality dermatome present text | SensySysAbnrmlyDermtPresTxt | The free-text field to describe the dermatome sensory abnormality, the area of skin supplied with afferent nerve fibers by a single posterior spinal root. | The free-text field to describe the dermatome sensory abnormality, the area of skin supplied with afferent nerve fibers by a single posterior spinal root. | Dermatome, explain | Alphanumeric | No references available | Adult;Pediatric | Proposed | 3.00 | 2013-07-30 14:29:49.047 | Neurological Exam | general-data-protection-regulation-gdpr | 255 |
Free-Form Entry |
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C14455 | Cerebellar or coordination assessment abnormality present status | CerbllCoordAssmtAbnrmlyPrsStat | Whether the cerebellar/coordination assessment found abnormalities | Whether the cerebellar/coordination assessment found abnormalities | Abnormality present? | Yes;No;Cannot Assess;Other, specify | Yes;No;Cannot Assess;Other, specify | Alphanumeric |
Choose one for each assessment type. Cannot Assess means the examiner does not know if the patient is normal or not; i.e. an uncooperative patient. |
No references available | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Neurological Exam | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C18937 | Muscle strength abnormality assessment other text | MuscStrAbnrmlyAssmtOTH | The free-text field related to 'Muscle strength abnormality assessment type' specifying other text. The muscle strength abnormality type | The free-text field related to 'Muscle strength abnormality assessment type' specifying other text. The muscle strength abnormality type | Other, specify | Alphanumeric | No references available | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Neurological Exam | general-data-protection-regulation-gdpr | 4000 |
Free-Form Entry |
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C14433 | Cranial nerves global assessment result | CranlNerveGlobAssmtReslt | The condition of Cranial Nerves | The condition of Cranial Nerves | Cranial nerves - global assessment | Normal;Abnormal;Cannot Assess;Other, specify | Normal;Abnormal;Cannot Assess;Other, specify | Alphanumeric |
Choose only one |
No references available | Adult;Pediatric | Proposed | 1.00 | 2012-10-05 00:00:00.0 | Neurological Exam | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C14469 | Sensory system modalities affected type | SensyModltyAffctTyp | The type and location of the sensory receptor activated by a stimulus plays the primary role in coding the stimulus modality | The type and location of the sensory receptor activated by a stimulus plays the primary role in coding the stimulus modality | Sensory Modalities Affected | Light Touch;Pain and Temperature;Vibration;Proprioception;Other, specify | Light Touch;Pain and Temperature;Vibration;Proprioception;Other, specify | Alphanumeric |
Choose all that apply |
No references available | Adult;Pediatric | Proposed | 1.00 | 2012-10-05 00:00:00.0 | Neurological Exam | general-data-protection-regulation-gdpr |
Multiple Pre-Defined Values Selected |
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C18948 | Sensory system abnormality anatomic other text | SensySysAbnrmlySymmAntmicOTH | The free-text field related to 'Sensory system abnormality anatomic site' specifying other text. The location of abnormality for sensory system | The free-text field related to 'Sensory system abnormality anatomic site' specifying other text. The location of abnormality for sensory system | Location of Abnormality | Alphanumeric |
Choose all that apply. If other, explain. |
No references available | Adult;Pediatric | Proposed | 1.00 | 2012-10-05 00:00:00.0 | Neurological Exam | general-data-protection-regulation-gdpr | 4000 |
Free-Form Entry |
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C14444 | Muscle tone assessment abnormality indicator | MuscToneAbnrmlyAssmtInd | Whether the muscle tone assessment found any abnormalities | Whether the muscle tone assessment found any abnormalities | Abnormality present? | Yes;No;Not assessed;Unknown | Yes;No;Not assessed;Unknown | Alphanumeric |
Choose one for each anatomic site |
No references available | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Neurological Exam | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||
C18514 | Sensory system abnormality participant description text | SensySysAbnrmlyPrtpDescTxt | The free-text field to capture the participant's description of the sensory abnormality. | The free-text field to capture the participant's description of the sensory abnormality. | Patient Description of abnormal symptoms | Alphanumeric | No references available | Adult;Pediatric | Proposed | 3.00 | 2013-07-30 14:29:49.047 | Neurological Exam | general-data-protection-regulation-gdpr | 255 |
Free-Form Entry |
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C14456 | Cerebellar or coordination assessment abnormality present type | CerbllCoordAssmtAbnrmlyPresTyp | Type of abnormality found by the cerebellar/coordination assessment | Type of abnormality found by the cerebellar/coordination assessment | If Abnormal, explain | RUE;LUE;Dysmetria;Slowness;Cannot assess due to weakness;Other, specify | Right upper extremity (RUE);Left upper extremity (LUE);Dysmetria;Slowness;Cannot assess due to weakness;Other, specify | Alphanumeric |
Choose all that apply. If abnormal, explain. "Cannot Assess due to Weakness" meant that the test of coordination is abnormal, but abnormal because of weakness (presumably not cerebellar in origin) rather than cerebellar dysfunction. |
No references available | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Neurological Exam | general-data-protection-regulation-gdpr |
Multiple Pre-Defined Values Selected |
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C18938 | Muscle weakness brain pattern other text | MuscWeakBrainPattrnOTH | The free-text field related to 'Muscle weakness brain pattern type' specifying other text. Patterns describing weakness in location of brain | The free-text field related to 'Muscle weakness brain pattern type' specifying other text. Patterns describing weakness in location of brain | Other, specify | Alphanumeric |
Choose all that apply. Describe if applicable. |
No references available | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Neurological Exam | general-data-protection-regulation-gdpr | 4000 |
Free-Form Entry |
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C14434 | Cranial nerve abnormal identifier type | CranlNerveAbnrmlIdTyp | The identified cranial nerve that assessed as abnormal. | The identified cranial nerve that assessed as abnormal. | Cranial Nerve Number | CN II;CN III;CN IV;CN V;CN VI;CN VII;CN VIII;CN IX;CN X;CN XI;CN XII;CN II;CN III;CN IV;CN V;CN VI;CN VII;CN VIII;CN IX;CN X;CN XI;CN XII | Cranial nerve II;Cranial nerve III;Cranial nerve IV;Cranial nerve V;Cranial nerve VI;Cranial nerve VII;Cranial nerve VIII;Cranial nerve IX;Cranial nerve X;Cranial nerve XI;Cranial nerve XII;Cranial nerve II;Cranial nerve III;Cranial nerve IV;Cranial nerve V;Cranial nerve VI;Cranial nerve VII;Cranial nerve VIII;Cranial nerve IX;Cranial nerve X;Cranial nerve XI;Cranial nerve XII | Alphanumeric |
Record which of the cranial nerves are abnormal and the side. Choose all that apply. |
No references available | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Neurological Exam | general-data-protection-regulation-gdpr |
Multiple Pre-Defined Values Selected |
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C18503 | Assessment unable text | AssmtUnableTxt | The free-text field to explain why there was no assessment of nystagmus performed. | The free-text field to explain why there was no assessment of nystagmus, involuntary movement of the eyeballs, performed. | Cannot Assess, explain | Alphanumeric | No references available | Adult;Pediatric | Proposed | 3.00 | 2013-07-30 14:29:49.047 | Neurological Exam | general-data-protection-regulation-gdpr | 255 |
Free-Form Entry |
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C18949 | Sensory system modalities affected other text | SensyModltyAffctOTH | The free-text field related to 'Sensory system modalities affected type' specifying other text. The type and location of the sensory receptor activated by a stimulus plays the primary role in coding the stimulus modality | The free-text field related to 'Sensory system modalities affected type' specifying other text. The type and location of the sensory receptor activated by a stimulus plays the primary role in coding the stimulus modality | Other, specify | Alphanumeric |
Choose all that apply |
No references available | Adult;Pediatric | Proposed | 1.00 | 2012-10-05 00:00:00.0 | Neurological Exam | general-data-protection-regulation-gdpr | 4000 |
Free-Form Entry |
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C14445 | Muscle tone assessment abnormality type | MuscToneAbnrmlyAssmtTyp | The muscle tone abnormality type | The muscle tone abnormality type | If abnormal, indicate type | Abnormal - Decreased;Abnormal - Increased;Other, specify | Abnormal - Decreased;Abnormal - Increased;Other, specify | Alphanumeric |
Choose one |
No references available | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Neurological Exam | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C18515 | Sensory system abnormality sensory nerve present text | SensySysAbnrmlySensNrvPresTxt | The free-text field to describe the sensory nerve abnormality. | The free-text field to describe the sensory nerve abnormality. | Sensory Nerve, explain | Alphanumeric | No references available | Adult;Pediatric | Proposed | 3.00 | 2013-07-30 14:29:49.047 | Neurological Exam | general-data-protection-regulation-gdpr | 255 |
Free-Form Entry |