This form structure is an organized set of data definitions for a form that has not been copyrighted

 General Details

Title:
FITBIR EEG form
Short Name:
EEG_FITBIR
Description:
This is a FITBIR EEG form that contains basic EEG information and metadata. The form is created based on 1) recommendations provided by NINDS and 2) FITBIR community input. References: Light GA, Williams LE, Minow F, Sprock J, Rissling A, Sharp R, Swerdlow NR, Electroencephalography (EEG) and event-related potentials (ERPs) with human participants. Braff DL.Curr Protoc Neurosci. 2010 Jul;Chapter 6:Unit 6.25.1-24. doi: 10.1002/0471142301.ns0625s52. https://www.ncbi.nlm.nih.gov/pubmed/20578033
Disease:
Traumatic Brain Injury , General (For all diseases)
Organization:
FITBIR
Required Program Form:
No
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Publication Date:
2017-04-10
Version:
1.0
Date Created:
2016-11-24
Owner:
Number of Data Elements:
89
eForms:
N

 Documentation


 Groups & Attached Data Elements

Logically grouped data elements with defined frequency at which they repeat.

# Title Short Description Variable Name Required? Type
1 GUID   Global Unique ID which uniquely identifies a subject GUID Required CDE
2 Subject identifier number   An identification number assigned to the participant/subject within a given protocol or a study. SubjectIDNum Optional CDE
3 Age in years   Value for participant's subject age recorded in years. AgeYrs Recommended CDE
4 Vital status   Status of participant/subject as alive or dead VitStatus Optional CDE
5 Visit date   Actual interview or visit date VisitDate Recommended CDE
6 Site name   The name of the site for the study SiteName Recommended CDE
7 Days since baseline   The number of days since baseline DaysSinceBaseline Optional CDE
8 Case control indicator   Indicator of whether subject is in the case or control arm of the study CaseContrlInd Optional CDE
9 General notes text   General notes GeneralNotesTxt Optional CDE

Additional Element Groups

Listed below are your additional element groups.

Form Administration (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Language form administration ISO code  Code (ISO 639-2) for the language that was used for CRF/instrument/scale/etc. administration LangCRFAdministratISOCode Recommended CDE
2 Language form administration ISO code other text  The free-text field related to 'Language used for CRF/instrument/scale/etc. administration ISO code' specifying other text. LangCRFAdministratISOCodeOTH Recommended CDE
3 Context type  The context to which the questions were answered ContextType Recommended CDE
4 Context type other text  The free-text related to ContextType specifying other text ContextTypeOTH Recommended CDE
5 Data source  Source of the data provided on the case report form DataSource Recommended CDE
6 Data source other text  The free-text field related to Data source specifying other text. Source of the data provided on the case report form DataSourceOTH Recommended CDE

Technical Information (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 EEG recording anatomic location type  Type of anatomic location (scalp or intracranial) where EEG recording was taking place. EEGRecordAnatLocTyp Recommended CDE
2 EEG recording system make text  Make of EEG recording system EEGRecordMakeTxt Recommended CDE
3 EEG recording system model text  Model of EEG recording system EEGRecordModelTxt Recommended CDE
4 EEG recording system model serial number  EEG recording system model serial number EEGRecordModelSerNum Optional CDE
5 EEG recording system software name  EEG recording system software name EEGRecordSoftwareName Recommended CDE
6 EEG recording system software version  EEG recording system software version EEGRecordSoftwareVer Optional CDE

Electrode Information (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 EEG recording system electrodes used number  Number of sensors/electrodes used in EEG recording EEGRecordElectrodNum Recommended CDE
2 EEG recording system electrodes used number other text  Number of sensors/electrodes used in EEG recording other than one which is specified in 'EEGRecordElectrodNum' EEGRecordElectrodNumOTH Optional CDE
3 EEG recording electrode montage type  Type of electrode montage used in EEG recording EEGRecordElectrodMontTyp Recommended CDE
4 EEG recording electrode montage type other text  Other text specifying 'EEG recording electrode montage type' EEGRecordElectrodMontTypOTH Optional CDE
5 EEG recording electrode locations file uploaded with the dataset indicator  Indicator if the EEG electrode locations file is uploaded with the dataset EEGRecordLocFileInd Recommended CDE
6 EEG recording electrode type  Type of electrodes used in EEG recording EEGRecordElectrodTyp Recommended CDE
7 EEG recording electrode type other text  Free text, related 'EEG recording electrode type' specifying other text EEGRecordElectrodTypOTH Optional CDE
8 EEG recording conductive material used type  Type of conductive material used in EEG recording EEGRecordConductMatTyp Recommended CDE
9 EEG recording conductive material used other text  Free text, related to 'EEG recording conductive material used type', specifying other text EEGRecordConductMatTypOTH Optional CDE
10 EEG recording reference electrode placement type  Type of reference electrode placement used in EEG recording EEGRecordRefElectrodPlcTyp Recommended CDE
11 EEG recording reference electrode placement type other text  Free text, related 'EEG recording reference electrode placement type' specifying other text EEGRecordRefElectrodPlcTypOTH Optional CDE

EEG Objectives (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Medical history condition SNOMED CT code  Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject MedclHistCondSNOMEDCTCode Recommended CDE
2 Medical history condition text  Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history MedclHistCondTxt Recommended CDE

EEG Recording Information (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 EEG recording start date and time  Date the electroencephalogram (EEG) recording began EEGRecordingStrtDate Recommended CDE
2 EEG recording end date and time  Date the electroencephalogram (EEG) recording ended EEGRecordingEndDate Recommended CDE
3 EEG data original purpose type  The reason(s) for gathering data via electroencephalogram (EEG) method EEGDataOriginalPurposeTyp Recommended CDE
4 EEG data original purpose other text  The free-text field related to 'EEG data original purpose type' specifying other text. The reason(s) for gathering data via electroencephalogram (EEG) method EEGDataOriginalPurposeOTH Optional CDE
5 EEG location type  The location of where the electroencephalogram (EEG) took place EEGLocTyp Recommended CDE
6 EEG location other text  The free-text field related to 'EEG location type' specifying other text. The location of where the electroencephalogram (EEG) took place EEGLocOTH Optional CDE
7 EEG monitoring type  Type of electroencephalogram (EEG) monitoring EEGMonitorType Recommended CDE
8 EEG prolonged duration type  The length of time for the prolonged electroencephalogram (EEG) EEGProlongedDurTyp Recommended CDE
9 EEG prolonged duration other text  The free-text field related to 'EEG prolonged duration type' specifying other text. The length of time for the prolonged electroencephalogram (EEG) EEGProlongedDurOTH Optional CDE
10 EEG recording time duration  Duration of time of EEG recording (in minutes). EEGRecordTimeDur Recommended CDE
11 EEG sampling rate  Sampling rate used for EEG recording (in Hz) EEGSamplingRate Recommended CDE
12 EEG recording low pass filter setting value  Low pass filter setting value (in HZ) used for EEG recording EEGRecordLowPassFilterVal Recommended CDE
13 EEG recording high pass filter setting value  High pass filter setting value (in HZ) used for EEG recording EEGRecordHighPassFilterVal Recommended CDE
14 EEG recording digital filter used text  Text describing a digital filter used for EEG recording EEGRecordDigitFilterTxt Recommended CDE
15 EEG recording electrode impedance value  Value of electrode impedance in EEG recording (in kOhm) EEGRecordImpedanceVal Recommended CDE
16 EEG recording electrode impedance value not available text  Text explaining why the value of electrode impedance in EEG recording is not available EEGRecordImpedanceTxt Optional CDE
17 EEG recording complete indicator  Indicator if the EEG recording is complete EEGRecordCompleteInd Recommended CDE
18 EEG recording incomplete reason text  Text explaining why the EEG recording wasn't complete EEGRecordIncompleteTxt Recommended CDE
19 EEG video indicator  A test involving simultaneous Electroencephalography (EEG) and video recording. EEGVideoInd Optional CDE
20 Video file available with EEG recording indicator  Indicator if the video recording file taken during EEG recording is available EEGVideoFileAvailableInd Optional CDE

Participant Information (Appears Up To 45 Times)

# Title Short Description Variable Name Required? Type
1 Medication prior or concomitant use indicator  Indicator of whether the participant/subject reported taking any medications during the time period relevant to the study protocol MedctnPriorConcomUseInd Recommended CDE
2 Medication prior or concomitant name  Name of the prior/concomitant agent or drug administered. MedctnPriorConcomName Recommended CDE
3 Substance use indicator  Indicate whether or not the subject showed signs of substance abuse (recreational drug or chronic alcohol use) at the time of injury and/or medical evaluation. SubUseInd Recommended CDE
4 Context type  The context to which the questions were answered ContextType Recommended CDE
5 Context type other text  The free-text related to ContextType specifying other text ContextTypeOTH Optional CDE
6 Substance used type  Type of substance (if any) digested/used before taking a given test (e.g. EEG test) SubstanceTyp Recommended CDE
7 Substance used type other text  Free text, related to 'Substance used type', specifying other text SubstanceTypOTH Optional CDE
8 EEG behavioral state recorded type  The recorded state(s) of the subject during the Electroencephalography (EEG) EEGBehavioralStateRecordedTyp Recommended CDE
9 EEG behavioral state recorded other text  The free-text field related to 'EEG behavioral state recorded type' specifying other text. The recorded state(s) of the subject during the electroencephalogram (EEG) EEGBehavioralStateRecordedOTH Optional CDE
10 EEG activating/stimuli procedures used indicator  Indicator, if any EEG activating/stimuli procedures were used during EEG recording EEGActivatingProcedUsedInd Recommended CDE
11 EEG activating procedures used type  Type(s) of procedures used to improve the Electroencephalography (EEG) diagnostic yield by inducing or enhancing epileptogenic paroxysms. EEGActivatingProcedUsedTyp Recommended CDE
12 EEG activating procedures used other text  The free-text field related to 'EEG activating procedures used type' specifying other text. Type(s) of procedures used to improve the electroencephalogram (EEG) diagnostic yield by inducing or enhancing epileptogenic paroxysms. EEGActivatingProcedUsedOTH Optional CDE
13 EEG activating/stimuli procedures file available indicator  Indicator, if a file with any EEG activating/stimuli procedures and timing is available EEGActivatingProcedFileInd Recommended CDE
14 EEG activating/stimuli procedures used text  Free text describing any EEG activating/stimuli procedures were used during EEG recording EEGActivatingProcedTxt Recommended CDE

EEG Raw Data Files (Appears Up To 45 Times)

# Title Short Description Variable Name Required? Type
1 EEG image quality result  The image quality from the electroencephalogram (EEG) EEGImgQualityReslt Recommended CDE
2 EEG recording plot file  EEG recording plot file. Could be a ZIP file. EEGRecordPlotFile Recommended CDE
3 EEG recording electrode location file  EEG recording electrode location file EEGRecordElectrodeLocFile Recommended CDE
4 EEG recording raw data file  EEG recording raw data files EEGRecordRawDataFile Recommended CDE
5 EEG recording activating procedure and/or stimuli events file  EEG recording activating procedure and/or stimuli events file with timing. Could be a ZIP file. EEGActivatingProcedFile Recommended CDE
6 EEG recording video file  EEG recording video file EEGRecordVideoFile Recommended CDE

EEG Raw Data Comments (Appears Up To 45 Times)

# Title Short Description Variable Name Required? Type
1 EEG occipital rhythm presence indicator  Indicator if occipital rhythm is present on EEG records EEGORPresentInd Recommended CDE
2 EEG background activity presence indicator  Indicator if background activity (BA) is present on EEG recording EEGBAPresentInd Recommended CDE
3 EEG artifacts present indicator  Indicator if any artifacts are present on EEG recording EEGArtifactsInd Recommended CDE
4 EEG comments text  Free text for EEG comments EEGCommentsTxt Recommended CDE
5 Brain region of interest type other text  Free text related to "Anatomic location of the region of interest (ROI) in the brain" specifying other text BrainROITypOTH Recommended CDE
6 Brain region of interest type  Anatomic location of the region of interest (ROI) in the brain BrainROITyp Recommended CDE
7 EEG activity morphology type  Type of morphology of EEG activity if it is emphasized in the EEG report EEGActivityMorphTyp Recommended CDE
8 EEG activity morphology transient -single wave type  Type of transient single-wave morphology of EEG activity if it is emphasized in the EEG report EEGActivityMorphTransSWTyp Recommended CDE
9 EEG activity morphology transient-complex waves type  Type of transient complex waves morphology of EEG activity if it is emphasized in the EEG report EEGActivityMorphTransComplTyp Recommended CDE
10 EEG activity morphology pattern type  Type of pattern morphology of EEG activity if it is emphasized in the EEG report EEGActivityMorphPatternTyp Recommended CDE
11 EEG activity magnitude type  Type of magnitude of EEG activity if it is emphasized in the EEG report EEGActivityMagnitudeTyp Recommended CDE
12 EEG activity recurrence type  Type of recurrence of EEG activity if it is emphasized in the EEG report EEGActivityRecurrenceTyp Recommended CDE

EEG Processed Data Files (Appears Up To 45 Times)

# Title Short Description Variable Name Required? Type
1 EEG recording processed data file  EEG recording processed data files. Could be a ZIP file. EEGRecordProcessedDataFile Recommended CDE
2 EEG recording sample duration  Duration of time of EEG recording sample (in seconds). If there are several samples stored in 'EEG recording raw data file', an average duration. EEGRecordSampleDur Recommended CDE
3 EEG comments text  Free text for EEG comments EEGCommentsTxt Recommended CDE

 Change History

 Administrative Change History