Sub-Domain: Additional Proposed Instruments
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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C14134 | Data valid through date and time | DataValidThroughDateTime | Date (and time, if applicable and known) the data collected are valid through | Date the data collected are valid through | Information complete up to | 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 | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Classification of Seizures | Additional Proposed Instruments | general-data-protection-regulation-gdpr |
Free-Form Entry |
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C18500 | Seizure present status | SeizPresentStatus | The status indicating whether a classified seizure is present. | The status indicating whether a classified seizure is present. | Present? | No;Possible;Probable;Definite;Unknown;N/A | No;Possible;Probable;Definite;Unknown;N/A | Alphanumeric | Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, Cross JH, van Emde Boas W, Engel J, French J, Glauser TA, Mathern GW, MoshÉ SL, Nordli D, Plouin P, Scheffer IE. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. Epub 2010 Feb 26. Freely available online at: http://www.ilae.org/Visitors/Centre/ctf/ctfoverview.cfm http://www.ilae-epilepsy.org/Visitors/Documents/ClassificationSummaryReportwebAug2009.pdf. | Adult;Pediatric | Proposed | 3.00 | 2013-07-30 14:29:49.047 | Classification of Seizures | Additional Proposed Instruments | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C06005 | Data collected date and time | DataCollDateTime | Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed. | Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed. | Date form completed | 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.). |
EPILEPSY: Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, et al. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. http://www.ilae-epilepsy.org/Visitors/Centre/ctf/ctfoverview.cfm | Adult;Pediatric | Proposed | 3.00 | 2013-07-24 21:00:23.88 | Classification of Seizures | Additional Proposed Instruments | general-data-protection-regulation-gdpr |
Free-Form Entry |
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C14125 | Seizure unclassifiable classification type | SeizUnclassClassTyp | Whether the participant/subject has experienced an unclassifiable seizure that is neither focal or generalized. | Whether the participant/subject has experienced an unclassifiable seizure that is neither focal or generalized. | Unclassified Seizure Type | Epileptic spasms, focal or generalized;Seizure type is unclassified;Epileptic spasms, focal or generalized;Seizure type is unclassified | Epileptic spasms, focal or generalized;Seizure type is unclassified (If a seizure cannot be adequately classified, it should not be fit into a category to which it does not belong.);Epileptic spasms, focal or generalized;Seizure type is unclassified (If a seizure cannot be adequately classified, it should not be fit into a category to which it does not belong.) | Alphanumeric |
Choose one for each seizure type or subtype identified. |
EPILEPSY: Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, et al. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. http://www.ilae-epilepsy.org/Visitors/Centre/ctf/ctfoverview.cfm | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Classification of Seizures | Additional Proposed Instruments | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
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C14126 | Seizure classification type | SeizClassTyp | The type of seizures present by classification. | The type of seizures present by classification. | Classification of Seizures | Generalized;Focal;Unclassified | Generalized;Focal;Unclassified seizures are considered unidentifiable due to lack of data and do not fit in to the aforementioned categories for Generalized and Focal Seizures | Alphanumeric |
Choose all that apply. Each seizure type needs to be answered using the permissible values for the "Seizure type or subtype present likelihood type" data element. It is possible for a participant/subject to have more than one seizure type. |
EPILEPSY: Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, et al. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. http://www.ilae-epilepsy.org/Visitors/Centre/ctf/ctfoverview.cfm | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Classification of Seizures | Additional Proposed Instruments | general-data-protection-regulation-gdpr |
Multiple Pre-Defined Values Selected |
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C14127 | Seizure generalized classification type | SeizGenClassTyp | The type of generalized epileptic seizures, considered to originate at some point within, and rapidly engage, bilaterally distributed networks and may include such bilateral networks as ortical and subcortical structures, but do not necessarily include the entire cortex, experienced by the participant/subject. | The type of generalized epileptic seizures, considered to originate at some point within, and rapidly engage, bilaterally distributed networks, experienced by the participant/subject. | Generalized Seizure Subtypes | Tonic clonic;Absence;Typical;Atypical;Myoclonic absence;Eyelid myoclonia;Myoclonic;Myoclonic atonic;Myoclonic tonic;Clonic;Tonic;Atonic | Tonic clonic (in any combination);Absence;Absence-Typical;Absence-Atypical;Absence-Myoclonic absence;Absence-Eyelid myoclonia;Myoclonic;Myoclonic-Myoclonic atonic;Myoclonic-Myoclonic tonic;Clonic;Tonic;Atonic | Alphanumeric |
Each seizure type needs to be answered using the permissible values for the "Seizure type or subtype present likelihood type" data element. It is possible for a participant/subject to have more than one seizure type. Although individual seizure onsets can appear localized, the location and lateralization are not consistent from one seizure to another. Generalized seizures can be asymmetric. |
EPILEPSY: Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, et al. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. http://www.ilae-epilepsy.org/Visitors/Centre/ctf/ctfoverview.cfm | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Classification of Seizures | Additional Proposed Instruments | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
DeBaun Forms | ||||||||||||||||||||||||||||
C14130 | Seizure focal classification type | SeizFocClassTyp | The type of focal epileptic seizures, considered to originate within networks limited to one hemisphere, which may be discretely localized or more widely distributed, and may originate in subcortical structures, experience by the participant/subject. | The type of focal epileptic seizures, considered to originate within networks limited to one hemisphere, which may be discretely localized or more widely distributed, and may originate in subcortical structures, experience by the participant/subject. | Focal Seizure Subtypes | Without impairment of consciousness or responsiveness;With observable motor or autonomic components;Involving subjective sensory or psychic phenomena only;With impairment of consciousness or responsiveness;Evolving to a bilateral, convulsive seizure | Without impairment of consciousness or responsiveness;Without impairment of consciousness or responsiveness-With observable motor or autonomic components (roughly corresponds to the concept of "simple partial seizure");Without impairment of consciousness or responsiveness-Involving subjective sensory or psychic phenomena only (corresponds to the concept of "aura");With impairment of consciousness or responsiveness (roughly corresponds to the concept of "complex partial seizure");Evolving to a bilateral, convulsive seizure (involving tonic, clonic, or tonic and clonic components replaces the term "secondarily generalized seizure") | Alphanumeric |
Each seizure type needs to be answered using the permissible values for the "Seizure type or subtype present likelihood type" data element. It is possible for a participant/subject to have more than one seizure type. For each seizure type, ictal onset is consistent from one seizure to another with preferential propagation patterns, which can involve the contralateral hemisphere. In some cases, however, there is more than one epileptogenic network, and more than one seizure type, but each individual seizure type has a consistent site of onset. Focal seizures do not fall into any recognized set of natural classes based on any current understanding of the mechanisms involved. |
EPILEPSY: Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, et al. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. http://www.ilae-epilepsy.org/Visitors/Centre/ctf/ctfoverview.cfm | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Classification of Seizures | Additional Proposed Instruments | general-data-protection-regulation-gdpr |
Multiple Pre-Defined Values Selected |
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C14132 | Seizures multiple confidence level distinct type | SeizMultConfLvlDistinctTyp | Confidence level that two or more seizure types recorded as present are distinct seizure types | Confidence level that two or more seizure types recorded as present are distinct seizure types | If two or more seizure types were selected as present, rate the confidence level that these are distinct seizure types | No confidence;Possible;Probable;Definite;Unknown;N/A | Not present;The summary of evidence suggests less than 50% confidence level;The summary of evidence suggests greater than 50% confidence level;The summary of evidence suggests 100% confidence level;The summary of evidence is not sufficient to support a finding;Not Applicable: to be used at the discretion of the Principal Investigator based on study design | Alphanumeric |
If two or more seizure types were selected as present, rate the confidence level that these are distinct seizure types |
EPILEPSY: Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, et al. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. http://www.ilae-epilepsy.org/Visitors/Centre/ctf/ctfoverview.cfm | Adult;Pediatric | Proposed | 3.00 | 2013-08-28 16:08:00.453 | Classification of Seizures | Additional Proposed Instruments | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |