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Form Structure: FITBIR Serious Adverse Events

This form structure is an organized set of data definitions for a form that has not been copyrighted
Title:
FITBIR Serious Adverse Events
Short Name:
SeriousAdvEvents_FITBIR
Description:
The Serious Adverse Event (SAE) Report is used to provide detailed information about each SAE that occurs during the study. It contains the information MedWatch, the FDA Safety Information and Adverse Event Reporting Program, requires for reporting SAEs.
Disease:
Traumatic Brain Injury
Organization:
NINDS
Required Program Form:
No
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Version:
1.0
Date Created:
2015-12-05
Owner:
Number of Data Elements:
56
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 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.

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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
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

Subject Information (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Sex participant or subject genotype type  Sex chromosomes of the participant/subject based upon genotyping SexSubjectGenotypTyp Recommended CDE
2 Weight measurement  Measurement of participant's/subject's weight WgtMeasr Recommended CDE
3 Weight unit of measure  Unit of measure for the weight numerical value WgtUoM Recommended CDE
4 Height measurement  Measurement of participant's/subject's height. HgtMeasr Recommended CDE
5 Height or length alternative unit of measure  Unit of measure for the height or length numerical value for subject/participant HgtLngthAltUoM Recommended CDE

Serious Adverse Event Information (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Serious adverse event indicator  The indicator of whether the adverse event is serious. SeriousAdvrsEvntInd Recommended CDE
2 Body system category  Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. BodySysCat Recommended CDE
3 Serious adverse event start date and time  Date of onset SerAdvrsEvntStartDateTime Recommended CDE
4 Serious adverse event end date and time  Date (and time, if applicable and known) on which the serious adverse event discontinued/stopped SeradvrsEvntEndDateTime Recommended CDE
5 Data collected date and time  Data collected date and time DataCollDateTime Recommended CDE
6 Injury elapsed time  The elapsed time (in minutes) from the time of injury InjElapsedTime Recommended CDE
7 Adverse event track number  The adverse tracking number that is associated with a particular medication listed. AdverseEventTrackNum Recommended CDE
8 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
9 Adverse event verbatim term text  Adverse event verbatim term text AdvrsEvntVerbatimTermText Recommended CDE
10 Serious adverse event treatment description text  The text that describes the interventions specific to the serious adverse event. SerAdvrsEvntTxDescText Recommended CDE
11 Serious adverse event laboratory data text  The text that describes the relevant tests or laboratory data specific to the serious adverse event. SerAdvrsEvntLabDataText Recommended CDE
12 Serious adverse event concomitant medications text  The text that describes the concomitant medications taken. SerAdvrsEvntConcomMedText Recommended CDE
13 Serious adverse event relevant history text  The text that describes relevant history including pre-existing medical conditions. SerAdvrsEvntRelHisText Recommended CDE
14 Serious adverse event resolution indicator  Indicates whether the adverse event was not resolved. SerAdvrsEvntRslnInd Recommended CDE
15 Adverse event outcome status  Final status of the participant/subject related to the adverse event AdvrsEvntOutcomStatus Recommended CDE
16 Serious adverse event outcome status  Final status of the participant/subject related to the serious adverse event SerAdvrsEvntOutcomStatus Recommended CDE
17 Serious adverse event outcome status other text  Free-text field to specify an alternate outcome attributed to the serious adverse event. SerAdvrsEvntOutStatOthTxt Recommended CDE
18 Serious adverse events comment text  Provide any additional information that pertains to the adverse event. SerAdvrsEvntCmntTxt Recommended CDE

Study Intervention Information (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Study protocol name  Name of study protocol StudyProtocolName Recommended CDE
2 Serious adverse event resolution indicator  Indicator to ask whether an adverse event ended after treatment with the study protocol drug or agent was stopped. SerAdvrsEvntResolInd Recommended CDE
3 Serious adverse event medication administration text  The free-text field to describe the administration of study intervention. SerAdvrsEvntMedAdmText Recommended CDE
4 Serious adverse event reappearance indicator  Indicate whether the adverse event reappeared after the treatment was restarted. SerAdvrsEvntReappInd Recommended CDE
5 Serious adverse event blind broken indicator  Indicate whether the study blind was broken. SerAdvrsEvntBlindBrokInd Recommended CDE

Principal Investigator Assessment (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Serious adverse event investigator assessment  Indicate the principal investigator's opinion of the cause of the event. SerAdvrsEvntInvAssess Recommended CDE
2 Investigator assessment concurrent disorder specify text  The free-text field to specify the concurrent disorder that might have caused the serious adverse event. InvestAssessConcurDisorSpecTxt Recommended CDE
3 Investigator assessment concomitant medication specify text  The free-text field to specify the concomitant medication that might have caused the serious adverse event. InvestAssessConcomMedSpecTxt Recommended CDE
4 Investigator assessment intervention withdrawal specify text  The free-text field to specify the details of the withdrawal of study intervention that might have caused the serious adverse event. InvestAssessIntrvWthdrlSpecTxt Recommended CDE
5 Serious adverse events anticipated indicator  Indicate whether the adverse event was anticipated. SerAdvrsEvntAnticInd Recommended CDE
6 Serious adverse event end treatment indicator  Indicate whether the study was discontinued due to the serious adverse event. SerAdvrsEvntEndTxInd Recommended CDE

Reporter Information (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Adverse event reporting identifier name  A name of an authorized group or person reporting the adverse event. AdvrsEvntRepIdName Recommended CDE
2 Serious adverse event report completed date  Date when the report on the adverse event was completed. SerAdvrsEvntRprtCompDt Recommended CDE
3 Serious adverse event report type  Specify which type of report is being completed for the adverse event. SerAdvrsEvntRepTyp Recommended CDE

Sponsor Assessment (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Unexpected adverse event indicator  The indicator of whether the adverse event is unexpected UnexpectAdvrsEvntInd Recommended CDE
2 Adverse event attribution indicator  Indicator of whether the adverse event was cause by the treatment in question. AdvrsEvntAttrInd Recommended CDE
Keywords

Change History