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

 General Details

Title:
FITBIR Adverse Event Tracking Log
Short Name:
AdvrseEventTrackLog_FITBIR
Description:
This form structure tracks additional information regarding Adverse Events. It contains additional elements and can be used as a supplement to Adverse_Events_FITBIR FS.
Disease:
Traumatic Brain Injury
Organization:
NINDS
Required Program Form:
No
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Publication Date:
2018-08-22
Version:
1.0
Date Created:
2015-12-05
Owner:
Number of Data Elements:
41
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 Recommended 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 Administrattion (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
7 Assessment completion status  Status of completion of an assessment, such as a case report from (CRF), instrument, scale, computer assessment, etc. AssessmentCompletionStat Recommended CDE
8 Assessment completion status text  A free text related to "Assessment completion status" specifying completion details. This data element should be used along with AssessmenttCompletionStat to further describe the status of assessment completion AssessmentCompletionStatTxt Recommended CDE

Adverse Event Tracking log (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Adverse event track number  The adverse tracking number that is associated with a particular medication listed. AdverseEventTrackNum Recommended CDE
2 Injury elapsed time  The elapsed time (in minutes) from the time of injury InjElapsedTime Recommended CDE
3 Data collected date and time  Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination, report, or the procedure performed. DataCollDateTime Recommended CDE
4 Adverse event reporting identifier name  A name of an authorized group or person reporting the adverse event. AdvrsEvntRepIdName Recommended CDE
5 Adverse event start date and time  Date (and time, if applicable and known) on which the adverse event was first evident AdvrsEvntStartDateTime Optional CDE
6 Adverse event end date and time  Date (and time, if applicable and known) on which the adverse event discontinued/stopped AdverseEvntEndDateTime Optional CDE
7 Adverse event during study indicator  Indicator of whether the participant/subject experienced any adverse events during the study AdvrsEvntDuringStudyInd Recommended CDE
8 Adverse event ongoing indicator  Indicator of whether adverse event is ongoing AdvseEventOngoingInd Recommended UDE
9 Adverse event verbatim term text  Adverse event verbatim term text AdvrsEvntVerbatimTermText Optional CDE
10 Adverse event CTCAE low level term name  Text that represents the Common Terminology Criteria for Adverse Events (CTCAE) low level term name for an adverse event. AdvrsEvntCTCAELowLvlTermName Optional CDE
11 Adverse event MedDRA lower level term code  Code that corresponds to the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) for an adverse event AdvEvntMedDRALowerLvlTermCode Optional CDE
12 Unexpected adverse event indicator  The indicator of whether the adverse event is unexpected UnexpectAdvrsEvntInd Recommended CDE
13 Event description text  The free-text field to describe the event including adverse event EvntDescrTxt Recommended CDE

Severity (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Adverse event severity scale  Scale of the severity or intensity of the adverse event AdvrsEvntSeverScale Optional CDE
2 Serious adverse event indicator  The indicator of whether the adverse event is serious. SeriousAdvrsEvntInd Recommended CDE

Relatedness (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Adverse event relatedness scale  The scale of the causality between the treatment modality/intervention and the specific adverse event. AdvrsEvntRelatednessScale Optional CDE
2 Adverse event relatedness scale other text  The free-text field related to 'Adverse event relatedness scale' specifying other text. AdvrsEvntRelatednessScaleOTH Recommended UDE
3 Adverse event relatedness source  What the adverse event or complication was likely related to or caused by AdvrsEvntRelatSrc Recommended CDE
4 Adverse event relatedness source other text  The free-text field related to 'Adverse event relatedness source' specifying other text. What the adverse event or complication was likely related to or caused by AdvrsEvntRelatOTH Recommended CDE
5 Adverse event attribution indicator  Indicator of whether the adverse event was cause by the treatment in question. AdvrsEvntAttrInd Recommended CDE

Actions taken (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Adverse event study intervention action taken type  The type of action taken for adverse event in relation to study intervention. AdvEvntStdyIntrvntActTakenTyp Optional CDE
2 Adverse event other action taken type  Type of action taken due to adverse event other than action taken with study intervention/ treatment AdvEvntOthrActionTakenTyp Recommended CDE
3 Adverse event AED action taken text  Text of action taken with the anti-epileptic drug (AED) due to the adverse event AdverseEventAEDActTxt Optional CDE

Outcome (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Adverse event outcome status  Final status of the participant/subject related to the adverse event AdvrsEvntOutcomStatus Optional CDE

 Change History

 Administrative Change History