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.
Disease:
Traumatic Brain Injury
Organization:
NINDS
Required Program Form:
Yes
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Version:
1.0
Date Created:
2019-02-06
Owner:
Number of Data Elements:
27
eForms:
N
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.
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
(Draft) |
Indicator of whether the participant/subject experienced any adverse events during the study | AdvrsEvntDuringStudyInd | Required | CDE |
2 |
Unexpected adverse event indicator
(Draft) |
The indicator of whether the adverse event is unexpected | UnexpectAdvrsEvntInd | Required | CDE |
3 |
Serious adverse event indicator
(Draft) |
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
(Draft) |
Adverse event verbatim term text | AdvrsEvntVerbatimTermText | Recommended | CDE |
6 |
Adverse event CTCAE low level term name
(Draft) |
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
(Draft) |
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
(Draft) |
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
(Draft) |
Date (and time, if applicable and known) on which the adverse event discontinued/stopped | AdverseEvntEndDateTime | Recommended | CDE |
10 |
Adverse event severity scale
(Draft) |
Scale of the severity or intensity of the adverse event | AdvrsEvntSeverScale | Recommended | CDE |
11 |
Adverse event relatedness scale
(Draft) |
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
(Draft) |
The type of action taken for adverse event in relation to study intervention. | AdvEvntStdyIntrvntActTakenTyp | Recommended | CDE |
13 |
Adverse event other action taken type
(Draft) |
Type of action taken due to adverse event other than action taken with study intervention/ treatment | AdvEvntOthrActionTakenTyp | Recommended | CDE |
14 |
Adverse event outcome status
(Draft) |
Final status of the participant/subject related to the adverse event | AdvrsEvntOutcomStatus | Recommended | CDE |
Keywords