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Form Structure: FITBIR Family History Form

This form structure is an organized set of data definitions for a form that has not been copyrighted
Title:
FITBIR Family History Form
Short Name:
FamilyHx_FITBIR
Description:
Family history for FITBIR. Includes general family history information, as well as use of history of illicit drugs used (if any), and history of TBI (if any). References: NINDS CDE TBI page -https://www.commondataelements.ninds.nih.gov/tbi.aspx#tab=Data_Standards
Disease:
Traumatic Brain Injury
Organization:
FITBIR
Required Program Form:
No
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Version:
1.0
Date Created:
2016-03-24
Owner:
Number of Data Elements:
95
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 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
6 Assessment completion status  Status of completion of an assessment, such as a case report from (CRF), instrument, scale, computer assessment, etc. AssessmentCompletionStat 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
9 BRICS Core CDE data completeness index  Index reflecting the completeness of data collected against core CDEs for a given row, as a ratio of completed Core CDEs vs the total number of Core CDEs for a given form BRICSCoreCDEDataCompletIndex Optional CDE
10 Data captured by type  Type of an individual (or a device) who captured the subject data and/or filled out the case report form (CRF), questionnaire, assessment form, computerized test, etc., including eFORMs and automatic sensors DataCapturedByTyp Recommended CDE
11 Data captured by other text  The free-text field related to "Data captured by whom type" specifying other text DataCapturedByTypOTH Optional CDE

Family Members Information (Appears Up To 36 Times)

# Title Short Description Variable Name Required? Type
1 Family history medical condition indicator  Indicator of whether a family member or first and second degree blood relatives of the participant/subject has had a history of the medical condition or health related event FamHistMedclCondInd Recommended CDE
2 Family history medical condition relative type  Relationship of the family member or ancestor with the medical condition or health related event to the participant/subject FamHistMedclCondReltvTy Recommended CDE
3 Family history medical condition relative other text  The free-text field related to 'Family history medical condition relative type' specifying other text. Relationship of the family member or ancestor with the medical condition or health related event to the participant/subject FamHistMedclCondReltvOTH Recommended CDE
4 Family history relative type biological sample in repository indicator  Indicator of whether the participant's/subject's family member has donated biological sample(s) to a repository FmlyHistRelTypBioSampleRepInd Recommended CDE
5 Family history relative type biological sample in repository count  Number of family members that have samples in a repository FmlyHistRelTypBioSamRepCt Recommended CDE

Family History Global Assessment (Appears Up To 25 Times)

# Title Short Description Variable Name Required? Type
1 Medical history taken date and time  Date (and time, if applicable and known) the participant/subject's medical history was taken MedclHistTakenDateTime Recommended CDE
2 Medical history for body system indicator  Indicator of whether the participant/subject has a history of medical problems/conditions for the specific body system. MedclHistBodySysInd Recommended CDE
3 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
4 Body system category other text  Free-text related to "Body System category" CDE used in the comprehensive assessment of a participant/subject.. BodySysOTH Recommended CDE
5 Family history medical condition relative count  Number of family members with medical condition FmlyHistMedclCondRelCt Recommended CDE
6 Medical history condition start date and time  Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history MedclHistCondStrtDateTime Recommended CDE
7 Medical history condition end date and time  Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history MedclHistCondEndDateTime Recommended CDE
8 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
9 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

Family History of TBIs (Appears Up To 3 Times)

# Title Short Description Variable Name Required? Type
1 Prior traumatic injury indicator  Indicator of prior traumatic injury found either historically, previous emergency department visits, radiographic findings, or signs or symptoms at time of presentation. PriorTraumInjryInd Recommended CDE
2 Prior traumatic injury type  General location of traumatic injury, if evidence of prior traumatic injury PriorTraumInjryType Recommended CDE
3 Head injury prior number  Number of prior head injuries, if previous TBI history HeadInjPriorNum Recommended CDE

Family History of Headaches and Migraines (Appears Up To 20 Times)

# Title Short Description Variable Name Required? Type
1 Headache history indicator  Indicates whether participant/subject suffers from headaches HeadachHistInd Recommended CDE
2 Headache migraine diagnosis indicator  Indicator of whether the participant/subject has been diagnosed with the type of headache or migraine HeadachMigranDiagnsInd Recommended CDE
3 Headache migraine type  Type of headache or migraine HeadachMigranTyp Recommended CDE
4 Additional comment text  Text describing any additional information about the participant or the participant's family history AddtnalCommntTxt Optional CDE

Family History of Medications (Appears Up To 9 Times)

# Title Short Description Variable Name Required? Type
1 Medication supplement use indicator  Indicator of whether the participant/subject has ever taken physician prescribed medications, investigational medications or supplements MedctnSupplUseInd Recommended CDE
2 Medication supplement name  Name of the medication or supplement administered MedctnSupplName Recommended CDE
3 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
4 Medication prior or concomitant name  Name of the prior/concomitant agent or drug administered. MedctnPriorConcomName Recommended CDE
5 Medication prior or concomitant ongoing indicator  Indicator of or description that the prior/concomitant medication usage is ongoing. MedctPrConcomOngoingInd Recommended CDE

Family History of Allergies (Appears Up To 9 Times)

# Title Short Description Variable Name Required? Type
1 Allergy diagnosis indicator  Indicator of whether the participant/subject has allergies. AllergyDiagnInd Recommended CDE
2 Allergy reported type  Type of allergy experienced, as reported by the participant/subject or proxy AllergyReportedTyp Recommended CDE
3 Allergy reported type other  The free-text field related to "Allergy reported type" specifying other text. AllergyReportedTypOTH Optional CDE
4 Allergy description text  Text for describing the allergy, including the list of allergens. AllergyDescriptionTxt Recommended CDE
5 Allergy reported reaction type  Type allergic reaction as reported by participant/subject or proxy AllergyReportedReactTyp Recommended CDE
6 Allergy reported reaction type other  The free-text field related to "Allergy reported reaction type" specifying other text. AllergyReportedReactTypOTH Optional CDE

Family History Behavioral History (Appears Up To 12 Times)

# Title Short Description Variable Name Required? Type
1 Alcohol current use indicator  Indicator of whether the participant/subject consumed at least one alcoholic drink within the past 12 months AlcCurntUseInd Recommended CDE
2 Alcohol prior use indicator  Indicator of the participant's/subject's alcohol consumption prior to the past 12 months AlcPriorUseInd Recommended CDE
3 Alcohol use duration  Duration in years participant/subject has used alcohol (ingesting of alcoholic beverages, including social drinking) AlcoholUseDuratn Optional CDE
4 Alcohol use started age value  Age in years when participant/subject started ingesting alcoholic beverages, including social drinking AlcUseStrtAgeVal Optional CDE
5 Alcohol use stopped age value  Age in years when participant/subject stopped ingesting alcoholic beverages, including social drinking AlcUseStopAgeVal Optional CDE
6 Drug or substance prior illicit use indicator  Indicator of participant's/subjects use of illegal drugs, prescription or over-the-counter drugs prior to the past 12 months for purposes other than those for which they are meant to be used, or in large amounts DrugSubstncPriorIllictUseInd Recommended CDE
7 Drug or substance current illicit use indicator  Indicator of participant's/subject's use of illegal drugs, prescription or over-the-counter drugs in the past year for purposes other than those for which they are meant to be used, or in large amounts DrgSubstCurrntIllicitUseCat Recommended CDE
8 Drug or substance illicitly used category  Category of illegal drugs, prescription, or over-the-counter drugs the participant/subject used for purposes other than those for which they are meant to be used, or in large amounts DrgSubIllctUseCat Optional CDE
9 Drug or substance illicit use duration  Duration, in years, the participant/subject has used an unprescribed, controlled psychoactive drugs or substances used by the participant/subject. DrgSubsIllctUseDur Optional CDE
10 Tobacco current use indicator  Indicator for whether the participant/subject regularly uses tobacco products (e.g. cigarettes, cigars, chewing tobacco or pipe) at the present time. TobcoUseCurntInd Recommended CDE
11 Tobacco prior use indicator  Indicator of the participant's/subject's past regular tobacco (e.g. cigarettes, cigars, chewing tobacco or pipe) use prior to the past 12 months TobcoPriorUseInd Recommended CDE
12 Tobacco use duration  Duration in years participant/subject has used tobacco products (e.g. cigarettes, cigars, chewing tobacco or pipe) TobcoUseDur Optional CDE
13 Tobacco product used type  Type of tobacco product (e.g. cigarettes, cigars, chewing tobacco or pipe) used by the participant/subject TobcoProdctUsedTyp Optional CDE
14 Tobacco product used other text  The free-text field related to 'Tobacco product used type' specifying other text. Type of tobacco product (e.g. cigarettes, cigars, chewing tobacco or pipe) used by the participant/subject TobcoProdctUsedOTH Recommended CDE

Family Medical History Categories (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Medical history global assessment indicator  Indicator of whether the participant/subject has a history of any medical problems/conditions MedclHistGlobalAssmtInd Recommended CDE
2 Medical history cardiovascular category  Medical history cardiovascular category MedHistCodeCardio Optional UDE
3 Medical history cardiovascular category other text  Medical history cardiovascular category other text MedHistCodeCardioOTH Optional UDE
4 Medical history developmental history category  Medical history developmental history category MedHistDevelopmentalHistory Optional UDE
5 Medical history developmental history category other text  Medical history developmental history category other text MedHistDevelopmentalHistoryOTH Optional UDE
6 Medical history endocrine category  Medical history endocrine category MedHistEndocrine Optional UDE
7 Medical history endocrine category other text  Medical history endocrine category other text MedHistEndocrineOTH Optional UDE
8 Medical history eye, ear, nose, and throat category  Medical history eye, ear, nose, and throat category MedHistEyeEarNoseThroat Optional UDE
9 Medical history eye, ear, nose, and throat category other text  Medical history eye, ear, nose, and throat category other text MedHistEyeEarNoseThroatOTH Optional UDE
10 Medical history gastrointestinal category  Medical history gastrointestinal category MedHistGastrointestinal Optional UDE
11 Medical history gastrointestinal category other text  Medical history gastrointestinal category other text MedHistGastrointestinalOTH Optional UDE
12 Medical history hematologic category  Medical history hematologic category MedHistHematologic Optional UDE
13 Medical history hematologic category other text  Medical history hematologic category other text MedHistHematologicOTH Optional UDE
14 Medical history hepatic category  Medical history hepatic category MedHistHepatic Optional UDE
15 Medical history hepatic category other text  Medical history hepatic category other text MedHistHepaticOTH Optional UDE
16 Medical history musculoskeletal category  Medical history musculoskeletal category MedHistMusculoskeletal Optional UDE
17 Medical history musculoskeletal category other text  Medical history musculoskeletal category other text MedHistMusculoskeletalOTH Optional UDE
18 Medical history neurologic category  Medical history neurologic category MedHistNeurologic Optional UDE
19 Medical history neurologic category other text  Medical history neurologic category other text MedHistNeurologicOTH Optional UDE
20 Medical history oncologic category  Medical history oncologic category MedHistOncologic Optional UDE
21 Medical history oncologic category other text  Medical history oncologic category other text MedHistOncologicOTH Optional UDE
22 Medical history psychiatric category  Medical history psychiatric category MedHistPsychiatric Optional UDE
23 Medical history psychiatric category other text  Medical history psychiatric category other text MedHistPsychiatricOTH Optional UDE
24 Medical history pulmonary category  Medical history pulmonary category MedHistPulmonary Optional UDE
25 Medical history pulmonary category other text  Medical history pulmonary category other text MedHistPulmonaryOTH Optional UDE
26 Medical history renal category  Medical history renal category MedHistRenal Optional UDE
27 Medical history renal category other text  Medical history renal category other text MedHistRenalOTH Optional UDE
28 Medical history social history category  Medical history social history category MedHistSocialHistory Optional UDE
29 Medical history social history category other text  Medical history social history category other text MedHistSocialHistoryOTH Optional UDE
Keywords

Change History