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Form Structure: FITBIR Adverse Events

This form structure is an organized set of data definitions for a form that has not been copyrighted
Title:
FITBIR Adverse Events
Short Name:
Adverse_Events_FITBIR
Description:
The Adverse Events (AEs) documents medical events that occur to a participant/subject once enrolled in a study. The AE form includes: the AE start date, severity, relatedness, outcome, and an indication of whether the event is serious. CDISC, Knowledge graph, See also
Disease:
Traumatic Brain Injury
Organization:
NINDS
Required Program Form:
Yes
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Publication Date:
2016-02-03
Version:
1.3
Date Created:
2015-12-04
Owner:
Number of Data Elements:
27
eForms:
Y
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 Recommended CDE
8 Case control indicator   Indicator of whether subject is in the case or control arm of the study. CaseContrlInd Recommended CDE
9 General notes text   General notes GeneralNotesTxt Recommended CDE

Additional Element Groups

Listed below are your additional element groups.

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Form Administration (Repeat Infinitely)

# Title Short Description Variable Name Required? Type
1 Context type  The context to which the questions were answered ContextType Recommended CDE
2 Context type other text  The free-text related to ContextType specifying other text ContextTypeOTH Recommended CDE
3 Data source  Source of the data provided on the case report form DataSource Recommended CDE
4 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

Adverse Events (Repeat Infinitely)

# Title Short Description Variable Name Required? Type
1 Adverse event during study indicator  Indicator of whether the participant/subject experienced any adverse events during the study AdvrsEvntDuringStudyInd Required CDE
2 Unexpected adverse event indicator  The indicator of whether the adverse event is unexpected UnexpectAdvrsEvntInd Recommended CDE
3 Serious adverse event indicator  The indicator of whether the adverse event is serious. SeriousAdvrsEvntInd Required CDE
4 Injury elapsed time  The elapsed time (in minutes) from the time of injury InjElapsedTime Recommended CDE
5 Adverse event verbatim term text  Adverse event verbatim term text AdvrsEvntVerbatimTermText Recommended CDE
6 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 Recommended CDE
7 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 Recommended CDE
8 Adverse event start date and time  Date (and time, if applicable and known) on which the adverse event was first evident AdvrsEvntStartDateTime Recommended CDE
9 Adverse event end date and time  Date (and time, if applicable and known) on which the adverse event discontinued/stopped AdverseEvntEndDateTime Recommended CDE
10 Adverse event severity scale  Scale of the severity or intensity of the adverse event AdvrsEvntSeverScale Recommended CDE
11 Adverse event relatedness scale  The scale of the causality between the treatment modality/intervention and the specific adverse event. AdvrsEvntRelatednessScale Recommended CDE
12 Adverse event study intervention action taken type  The type of action taken for adverse event in relation to study intervention. AdvEvntStdyIntrvntActTakenTyp Recommended CDE
13 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
14 Adverse event outcome status  Final status of the participant/subject related to the adverse event AdvrsEvntOutcomStatus Recommended CDE
Keywords

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