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Form Structure: TRACK TBI Pilot Subject

This form structure is an organized set of data definitions for a form that has not been copyrighted
Resource:
FITBIR
Title:
TRACK TBI Pilot Subject
Short Name:
TRACKTBI_Subject
Description:
Subject form for the TRACK TBI Pilot study
Disease:
Traumatic Brain Injury
Organization:
NIH
Required Program Form:
No
Standardization:
Unique
Labels:
Form Type:
Clinical Assessment
Publication Date:
2014-09-12
Version:
1.0
Date Created:
2014-08-14
Owner:
Number of Data Elements:
74
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 Visit date   Actual interview or visit date VisitDate Recommended CDE
5 Site name   The name of the site for the study SiteName Recommended CDE
6 Days since baseline   The number of days since baseline DaysSinceBaseline Optional CDE
7 Case control indicator   Indicator of whether subject is in the case or control arm of the study. CaseContrlInd Optional CDE
8 General notes text   General notes GeneralNotesTxt Optional CDE

Additional Element Groups

Listed below are your additional element groups.

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Subject Demographics (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Sex type  Self-reported sex of the participant/subject. GenderTyp Recommended CDE
2 Race USA category  The subject self declared racial origination, independent of ethnic origination, using OMB approved categories. RaceUSACat Recommended CDE
3 Race category  Category of race(s) or region(s) the participant/subject most closely identifies with RaceCat Recommended CDE
4 USA, Mexico, or Canada country of residence  USA, Mexico, or Canada country of residence indicator CountryOfResidence Recommended UDE
5 USA, Mexico, or Canada country of residence other text  Country Of Residence (other than USA, Mexico, or Canada ) CountryOfResidenceOTH Recommended UDE
6 Birth country name  Name for country where the participant/subject was born BirthCntryName Recommended CDE
7 Ethnicity USA category  Category of ethnicity the participant/subject most closely identifies with EthnUSACat Recommended CDE
8 Hand preference type  Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively. HandPrefTyp Recommended CDE
9 Education year count  Number of years of education completed (age 5 and beyond) EduYrCt Recommended CDE
10 Highest education level of adult patient  Highest education level achieved for adult patient SesEduTypeAdult Recommended UDE
11 Unable to obtain the education information reason  Unable to obtain the education information reason SesEduTypeAdultNoInfo Recommended UDE
12 Other reason, why it was not possible to obtain the education information  Unable to obtain the education information reason (other) SesEduTypeAdultNoInfoOther Recommended UDE
13 Employment status of adult patient  Employment status of adult patient SesEmpl Recommended UDE
14 Employment status of adult patient other text  Employment status of adult patient other text SesEmplOTH Recommended UDE
15 Unable to obtain the employment information reason  Unable to obtain the information reason SesEmplNoInfo Recommended UDE
16 Other reason, why it was not possible to obtain the employment information  Unable to obtain the employment information reason (other) SesEmplNoInfoOther Recommended UDE
17 Marital status of adult patient  Marital Status of adult patient SesMarriageStatus Recommended UDE
18 Marital status of adult patient other text  Marital status of adult patient other text SesMarriageStatusOTH Recommended UDE
19 Unable to obtain the marital status information reason  Unable to obtain the marital status information reason SesMarriageStatusNoInfo Recommended UDE
20 Other reason, why it was not possible to obtain the marital status information  Unable to obtain the marital status information reason (other) SesMarriageStatusNoInfoOther Recommended UDE
21 School status of patient  School status of patient SchoolStatus Recommended UDE
22 School status of patient other text  School status of patient (both adult and child) other text SchoolStatusOTH Recommended UDE
23 Unable to obtain the information about the school status of patient  Unable to obtain the information about the school status of patient reason SchoolStatusNoInfo Recommended UDE
24 Other reason, why it was not possible to obtain the information about the school status of patient  Unable to obtain the information about the school status of patient reason (other) SchoolStatusNoInfoOther Recommended UDE
25 Living situation of an adult subject  Living situation of an adult subject, including the primary person living with adult subject information SesPrimAdult Recommended CDE
26 Other primary person living with adult patient  Other Primary person living with adult patient SesPrimAdultOther Recommended CDE
27 Unable to obtain the information about the primary person living with the adult patient reason  Unable to obtain the primary person living with the adult patient information reason SesPrimAdultNoInfo Recommended UDE
28 Other reason, why it was not possible to obtain the information about the primary person living with the adult patient  Unable to obtain the primary person living with the adult patient information reason (other) SesPrimAdultNoInfoOther Recommended UDE
29 Living situation of juvenile patient  Living situation of juvenile patient SesPrimChild Recommended CDE
30 Unable to obtain the information about the primary person living with the child patient reason  Unable to obtain the primary person living with the child patient information reason SesPrimChildNoInfo Recommended UDE
31 Unable to obtain the information about the primary person living with the child patient reason other  Unable to obtain the primary person living with the child patient information reason (other) SesPrimChildNoInfoOther Recommended UDE
32 Number of years of school completed by father of juvenile patient  Number of years of school completed by father of juvenile patient SesEduNoFather Recommended UDE
33 Number of years of school completed by mother of juvenile patient  Number of years of school completed by mother of juvenile patient SesEduNoMother Recommended UDE
34 Highest education level of father of juvenile patient  Highest education level of father of juvenile patient SesEduTypeFather Recommended UDE
35 Highest education level of father of juvenile patient other text  Highest education level of father of juvenile patient other text SesEduTypeFatherOTH Recommended UDE
36 Unable to obtain the education information for a father reason  Unable to obtain the education information for a father reason SesEduTypeFatherNoInfo Recommended UDE
37 Unable to obtain the education information for a father reason - other  Unable to obtain the education information for a father reason (other) SesEduTypeFatherNoInfoOther Recommended UDE
38 Highest education level of mother of juvenile patient  Highest education level of mother of juvenile patient SesEduTypeMother Recommended UDE
39 Highest education level of mother of juvenile patient other text  Highest education level of mother of juvenile patient other text SesEduTypeMotherOTH Recommended UDE
40 Unable to obtain the education information for a mother reason  Unable to obtain the education information for a mother reason SesEduTypeMotherNoInfo Recommended UDE
41 Unable to obtain the education information for a mother reason - other  Unable to obtain the education information for a mother reason (other) SesEduTypeMotherNoInfoOther Recommended UDE
42 Active military status indicator  Whether participant currently has active military status MilActiveInd Recommended CDE
43 Military USA service branch type  Branch of service in the U.S. military, not including the Commissioned Corps MilUSAServBrnchTyp Recommended CDE
44 Military rank of military patient  Military rank of military patient MilRank Recommended UDE
45 Military occupational status of participant  Military occupational status of participant MilMOS Recommended CDE
46 To where the military patient was deployed  Region or country the military patient was deployed MilDeploy Recommended CDE
47 To where the military patient was deployed other text  Region or country to where the military patient was deployed other text MilDeployOTH Recommended CDE
48 Patient category  Patient Category PatientType Recommended UDE
49 Primary language of patient  Primary language of patient PrimaryLanguage Recommended UDE
50 Other language (not listed in the PrimaryLanguage list)  Other language (not listed in the PrimaryLanguage list) PrimaryLanguageOther Recommended UDE

Informed Consent (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Who signed the consent form  Who signed the consent form InfConsTyp Recommended UDE
2 Whether consent was before of after enrollment in study  Whether consent was before of after enrollment in study InfConsWhen Recommended UDE
3 Whether assent was before or after enrollment in study (pediatric patient)  Whether assent was before or after enrollment in study (pediatric patient) InfConsWhenPediatric Recommended UDE
4 Which staff person obtained the consent  Which staff person obtained the consent InfConsBy Recommended UDE
5 Which staff person obtained the consent other text  Which staff person obtained the consent other text InfConsByOTH Recommended UDE
6 Time since injury for informed consent 

(Retired)

 		Time since injury (recorded in minutes) for Informed Consent InjElapsedTimeInfConsent Recommended UDE
7 Consent obtained for data indicator  Consent obtained for data indicator ConsentData Recommended UDE
8 Consent obtained for plasma indicator  Consent obtained for plasma indicator ConsentPlasma Recommended UDE
9 Consent obtained for DNA indicator  Consent obtained for DNA indicator ConsentDNA Recommended UDE
10 Consent obtained for MRI indicator  Consent obtained for MRI indicator ConsentMRI Recommended UDE
11 Consent obtained for outcome measures indicator  Consent obtained for outcome measures indicator ConsentOutcomeMeasures Recommended UDE
12 Consent withdrawn information  Consent withdrawn information ConsentWithdrawnInfo Recommended UDE
13 Time since injury consent withdrawn 

(Retired)

 		Time since injury (recorded in minutes) consent withdrawn InjElapsedTimeConsentWithdrawn Recommended UDE

Research Info (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Status at final study contact  Status at final study contact FinalStudyContactStatus Recommended UDE
2 Status at final study contact other text  Status at final study contact other text FinalStudyContactStatusOTH Recommended UDE
3 Quality assurance status  Quality Assurance Status QAStatus Recommended UDE
Keywords