Trauma Core CDEs

The Trauma Core Common Data Elements (CDEs) will be the set of data collected on ALL subjects in EVERY trauma study. The Trauma Core CDEs posted in the table below include those belonging to version 1 of the NTRR, the FITBIR General Core, and the FITBIR TBI Core. This set of draft Core CDEs is currently under review by the NTRR CDE Steering Committee for final Trauma Core CDE selection, and it is available for review and vetting by the larger research community until January 31, 2024 (See Feedback tab).

NTRR CORE COMMON DATA ELEMENTS

Original Source	variable name	title	element type	Version	definition	short description	datatype	maximum character quantity	input restriction	minimum value	maximum value	permissible values	permissible value descriptions	permissible value output codes	unit of measure	guidelines/instructions	notes	preferred question text	keywords	references	external ID.caDSR	external ID.CDISC	external ID.NINDS	population.all	domain.trauma	classification.NTRR core	classification.Outcome/QOL	classification.Rehab	classification.Inpatient	classification.Prehospital	domain.general (for all diseases)	domain.traumatic brain injury	domain.Parkinson's disease	domain.Friedreich's ataxia	domain.stroke	domain.amyotrophic lateral sclerosis	domain.Huntington's disease	domain.multiple sclerosis	domain.neuromuscular diseases	domain.myasthenia gravis	domain.spinal muscular atrophy	domain.Duchenne muscular dystrophy/Becker muscular dystrophy	domain.spinal cord injury	domain.headache	domain.epilepsy	classification.general (for all diseases)	classification.acute hospitalized	classification.concussion/mild TBI	classification.epidemiology	classification.moderate/severe TBI: rehabilitation	classification.Parkinson's disease	classification.Friedreich's ataxia	classification.stroke	classification.amyotrophic lateral sclerosis	classification.Huntington's disease	classification.multiple sclerosis	classification.neuromuscular diseases	classification.myasthenia gravis	classification.spinal muscular atrophy	classification.Duchenne muscular dystrophy/Becker muscular dystrophy	classification.spinal cord injury	classification.headache	classification.epilepsy	historical notes	submitting organization name	submitting contact name	submitting contact information	steward organization name	steward contact name	steward contact information	creation date	last change date	administrative status
FITBIR General Core	EnrldStdyDateTime	Enrolled in study date and time	Common Data Element		Date (and time, if applicable and known) the participant/subject is enrolled into the study	Date (and time, if applicable and known) the participant/subject is enrolled into the study	Date or Date & Time		Free-Form Entry							GENERAL: Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http: //www.iso.org/iso/home.html). The date (and time) should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database.	Data Sharing Instructions: When date/time data are prepared for aggregation or sharing they should be converted to the format specified by ISO 8601, YYYY-MM-DDThh:mm:ss.	Date Enrolled		No references available				Adult and Pediatric							Protocol Experience.Participant/Subject Identification, Eligibility, and Enrollment															Core																		Enrolled in study date and time	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core	EnrldStdyInd	Enrolled in study indicator	Common Data Element		Indicator of whether the participant/subject was enrolled into the clinical research study.	Indicator of whether the participant/subject was enrolled into the clinical research study.	Alphanumeric		Single Pre-Defined Value Selected			No;Unknown;Yes	No;Unknown;Yes	0;9;1		GENERAL: Choose one. If YES, record the date enrolled.		Was the participant/subject enrolled into the study?		No references available				Adult and Pediatric							Protocol Experience.Participant/Subject Identification, Eligibility, and Enrollment															Core																		Enrolled in study indicator	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core	InfConsntObtInd	Informed consent obtained indicator	Common Data Element		Indicator of whether informed consent was obtained for the participant/subject to participate in the clinical research study.	Indicator of whether informed consent was obtained for the participant/subject to participate in the clinical research study	Alphanumeric		Single Pre-Defined Value Selected			No;Unknown;Yes	No;Unknown;Yes	0;9;1		GENERAL: Choose one. If YES, record date informed consent was obtained.		Was informed consent obtained?		No references available				Adult and Pediatric							Protocol Experience.Participant/Subject Identification, Eligibility, and Enrollment															Core																		Informed consent obtained indicator	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core	InformConsntObtnDateTime	Informed consent obtained date and time	Common Data Element		Date (and time, if applicable and known) on which the participant/subject (or the legal representative on behalf of the participant/subject) agrees to participate in a protocol, treatment, or other activity by signing an informed consent document.	Date (and time, if applicable and known) on which the participant/subject (or the legal representative on behalf of the participant/subject) agrees to participate in a protocol, treatment, or other activity by signing an informed consent document.	Date or Date & Time		Free-Form Entry							GENERAL: Record the date(and time) the informed consent form is signed. The date/time should be recorded to the level of granularity known(e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database. TBI: Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http: //www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).	Data Sharing Instructions: When date/time data are prepared for aggregation or sharing they should be converted to the format specified by ISO 8601, YYYY-MM-DDThh:mm:ss.	Date and time of informed consent		GENERAL: No references available TBI: 21 CFR 50.20 General requirements for informed consent A Guide to Informed Consent - Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators Contents (http: //www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm#general)				Adult and Pediatric							Protocol Experience.Participant/Subject Identification, Eligibility, and Enrollment	Protocol Experience.Participant/Subject Identification, Eligibility, and Enrollment														Core	Supplemental	Supplemental	Supplemental	Supplemental														Informed consent obtained date and time	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core	MedclHistCondStrtDateTime	Medical history condition start date and time	Common Data Element		Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history	Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history	Date or Date & Time		Free-Form Entry							Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http: //www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.). At a minimum the start year (YYYY) should be recorded. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http: //www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).	Data Sharing Instructions: When date/time data are prepared for aggregation or sharing they should be converted to the format specified by ISO 8601, YYYY-MM-DDThh:mm:ss.	Medical history TBI condition start date and time	Medical_History	SCI: Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Bieringarensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8): 586-90.				Adult and Pediatric							Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History		Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History		Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	N/A.N/A			Core	Supplemental	Supplemental	Supplemental	Supplemental		Supplemental	Supplemental	Core		Supplemental	Core	Core	Supplemental	Core	Supplemental			Medical history condition start date and time	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core	MedclHistTakenDateTime	Medical history taken date and time	Common Data Element		Date (and time, if applicable and known) the participant/subject's medical history was taken	Date (and time, if applicable and known) the participant/subject's medical history was taken	Date or Date & Time		Free-Form Entry							Record the date (and time) the medical history was taken. The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http: //www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).	Data Sharing Instructions: When date/time data are prepared for aggregation or sharing they should be converted to the format specified by ISO 8601, YYYY-MM-DDThh:mm:ss.	Date the medical history taken	Medical_History	No references available				Adult and Pediatric							Participant/Subject History and Family History.General Health History		Disease/Injury Related Events.History of Disease/Injury Event	Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History		Participant/Subject History and Family History.General Health History	Disease/Injury Related Events.History of Disease/Injury Event;Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	Disease/Injury Related Events.History of Disease/Injury Event;Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History				Core					Supplemental	Core	Supplemental	Supplemental		Supplemental	Core	Core	Supplemental	Core				Medical history taken date and time	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core	OffStdyDateTime	Off study date and time	Common Data Element		Date (and time, if applicable and known) when participant/subject completes study or is prematurely withdrawn from study (i.e., is not being followed and will not receive intervention/treatment)	Date (and time, if applicable and known) when participant/subject completes study or is prematurely withdrawn from study (i.e., is not being followed and will not receive intervention/treatment)	Date or Date & Time		Free-Form Entry							GENERAL: Record the date (and time) of the participant's/ subject's last study related-contact. This may be the study completion visit or follow-up visit/phone call. The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database.	Data Sharing Instructions: When date/time data are prepared for aggregation or sharing they should be converted to the format specified by ISO 8601, YYYY-MM-DDThh:mm:ss.	Off study date		No references available				Adult and Pediatric							Protocol Experience.Off Treatment/Off Study															Core																		Off study date and time	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core	OffStdyRsn	Off study reason	Common Data Element		Primary reason participant/ subject is no longer participating in study (i.e., is not being followed and will not receive intervention/treatment).	Primary reason participant/ subject is no longer participating in study (i.e., is not being followed and will not receive intervention/treatment).	Alphanumeric		Single Pre-Defined Value Selected			Completed study;Died;Lost to follow-up (or cannot be located);Refused further participation (or withdrew consent)	Completed study;Died;Lost to follow-up (or cannot be located);Refused further participation (or withdrew consent)	1;2;3;4		GENERAL: Choose one. Specify the status of the participant/ subject at his/her last study-related contact. If the final study contact status is Dead then a Death Report Form may need to be completed for this participant/ subject.		Off study reason		No references available				Adult and Pediatric							Protocol Experience.Off Treatment/Off Study															Core																		Off study reason	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core	StdyEligibilityInd	Study eligibility indicator	Common Data Element		Indicator of whether the participant/subject is eligible for participation in the clinical research protocol according to its inclusion and exclusion criteria	Indicator of whether the participant/subject is eligible for participation in the clinical research protocol according to its inclusion and exclusion criteria	Alphanumeric		Single Pre-Defined Value Selected			No;Unknown;Yes	No;Unknown;Yes	0;9;1		GENERAL: The participants/subject is eligible for study enrollment if all the inclusion criteria are answered YES and all the exclusion criteria are answered NO or N/A.		Is the participant subject eligible for study enrollment based on the above criteria?		No references available				Adult and Pediatric							Protocol Experience.Participant/Subject Identification, Eligibility, and Enrollment															Core																		Study eligibility indicator	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core/FITBIR TBI Core	BirthDate	Birth date	Common Data Element		Date (and time, if applicable and known) the participant/subject was born	Date (and time, if applicable and known) the participant/subject was born	Date or Date & Time		Free-Form Entry							Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http: //www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.). Recording date of birth will give the most detailed information required for calculation of age and is recommended as first choice. However, in some studies recording date of birth may elicit discussions on a potential violation of privacy legislation and specifically HIPAA regulations. In these cases, the calculated age should be recorded.	Data Sharing Instructions: When date/time data are prepared for aggregation or sharing they should be converted to the format specified by ISO 8601, YYYY-MM-DDThh:mm:ss.	What is the subject's date of birth?	Core_TBI	ISO 8601 - http: //www.iso.org/iso/iso_catalogue.htm Management and prognosis of severe traumatic brain injury: Age. J Neurotrauma. 2000;17: 573-581. Mushkudiani NA, Engel DC, Steyerberg EW, et al. Prognostic value of demographic characteristics in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2): 259-69. Pediatric-specific reference(s): Anderson V, Catroppa C, Morse S, Haritou F, Rosenfeld J (2005) Functional plasticity or vulnerability after early brain injury. Pediatric 116: 1374-1382	793		C00007	Adult and Pediatric							Protocol Experience.Participant/Subject Identification, Eligibility, and Enrollment;Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Assessments and Examinations.Other Clinical Data;Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics		N/A.N/A	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Core	Core	Core	Core	Core	Core	Core	Core	Core	Supplemental	Core	Core	Core	Core		Core	Core	Core	Birth date	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core/FITBIR TBI Core	EduSchoolParticipStatus	Education school participation status	Common Data Element		Status of participant/subjects current attendance at school	Status of participant/subjects current attendance at school	Alphanumeric		Single Pre-Defined Value Selected			Going to school;Neither;On vacation from school (between grades);Unknown	Going to school;Neither;On vacation from school (between grades);Unknown	1;2;3;4		Choose one. Recommend collection at least on date of TBI.		What is the subject current attendance in school?	Core_TBI	National Health and Nutrition Examination Survey (http: //www.cdc.gov/nchs/nhanes.htm)			C00202	Adult and Pediatric							Participant/Subject Characteristics.Social Status;Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Social Status;Participant/Subject Characteristics.Demographics							Participant/Subject Characteristics.Social Status		Participant/Subject Characteristics.Social Status					Core	Core	Core	Core	Core							Supplemental		Supplemental					Education school participation status	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core/FITBIR TBI Core	EmplmtOTH	Employment other text	Common Data Element		The free-text field related to 'Employment status' specifying other text. Status of participant/subject's current employment	The free-text field related to 'Employment status' specifying other text. Status of participant/subject's current employment	Alphanumeric	4000	Free-Form Entry							FA: Choose one. ----- NMD: Choose one ----- SMA: Choose one ----- EPILEPSY: Choose one ----- STROKE: National Health and Nutrition Examination Survey (http://www.cdc.gov/nchs/nhanes.htm) ----- MS: Choose one. ----- HEADACHE: Choose all that apply. ----- GENERAL: For years completed, code the number of years attained (0-30 years), normed to someone moving full time at the usual pace, i.e. a year that was repeated counts as only 1 year and the usual single-year full-time load completed over several years counts as 1 year. Certificate and technical programs do NOT count no matter how specialized. The number of years of typical completion of the relevant program is counted. If the subject obtained their education outside the United States, ask about their educational system to estimate the correct coding - Internship, Residency, and Fellowship years are experiential training and do not count. Recommend collection at least on date of TBI.	Return to work is a relevant outcome parameter in patients in paid workforce prior to injury. If post injury employment is an outcome, pre-injury employment is an important predictor.	Other, specify	Core_TBI	EPILEPSY?FA/GENERAL/HEADASHE/MS/NMD/SMA/STROKE: National Health and Nutrition Examination Survey (http://www.cdc.gov/nchs/nhanes.htm)			C18677	Adult and Pediatric							Participant/Subject Characteristics.Demographics;Participant/Subject Characteristics.Social Status	Participant/Subject Characteristics.Social Status;Participant/Subject Characteristics.Demographics		Participant/Subject Characteristics.Social Status	Participant/Subject Characteristics.Social Status			Participant/Subject Characteristics.Social Status	Participant/Subject Characteristics.Social Status		Participant/Subject Characteristics.Social Status			Participant/Subject Characteristics.Social Status	Participant/Subject Characteristics.Social Status	Core	Core	Core	Core	Core		Supplemental	Supplemental			Supplemental	Supplemental		Supplemental			Core	Supplemental		NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com	NIH/CIT/BRICS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core/FITBIR TBI Core	EmplmtStatu	Employment status	Common Data Element		Status of participant/subject's current employment	Status of participant/subject's current employment	Alphanumeric		Single Pre-Defined Value Selected			Disabled, permanently or temporarily;Keeping house;Looking for work, unemployed;Only temporarily laid off;Other, specify;Retired;Sick leave or maternity leave;Student;Unknown;Working Now	Disabled, permanently or temporarily;Keeping house;Looking for work, unemployed;Only temporarily laid off;Other, specify;Retired;Sick leave or maternity leave;Student;Unknown;Working Now	1;2;3;4;444;6;7;8;999;10		For years completed, code the number of years attained (0-30 years), normed to someone moving full time at the usual pace, i.e. a year that was repeated counts as only 1 year and the usual single-year full-time load completed over several years counts as 1 year. Certificate and technical programs do NOT count no matter how specialized. The number of years of typical completion of the relevant program is counted. If the subject obtained their education outside the United States, ask about their educational system to estimate the correct coding - Internship, Residency, and Fellowship years are experiential training and do not count. Recommend collection at least on date of TBI.	Return to work is a relevant outcome parameter in patients in paid workforce prior to injury. If post injury employment is an outcome, pre-injury employment is an important predictor.	Employment status	Core_TBI	No references available			C00204	Adult and Pediatric							Participant/Subject Characteristics.Social Status;Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Social Status;Participant/Subject Characteristics.Demographics		Participant/Subject Characteristics.Social Status	Participant/Subject Characteristics.Social Status			Participant/Subject Characteristics.Social Status	Participant/Subject Characteristics.Social Status		Participant/Subject Characteristics.Social Status			Participant/Subject Characteristics.Social Status	Participant/Subject Characteristics.Social Status	Core	Core	Core	Core	Core		Supplemental	Supplemental			Supplemental	Supplemental		Supplemental			Core	Supplemental		NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core/FITBIR TBI Core	GenderTyp	Gender Type	Common Data Element		Self-reported gender of the participant/subject. Gender is the socially constructed identity of sex. Gender is equated with phenotypic sex. Gender may differ from the sex of an individual determined genetically.	Self-reported gender of the participant/subject. Gender is the socially constructed identity of sex.	Alphanumeric		Single Pre-Defined Value Selected			Female;Male;Not reported;Unknown;Unspecified	Female;Male;Not Reported;Unknown;Undifferentiated/Indeterminant/Intersex	1;2;222;999;555		Choose one. Response is obtained by report of the participant/subject or caretaker.	The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm)	What is the subject's gender?	Core_TBI	The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 (http: //grants.nih.gov/grants/funding/women_min/guidelines_update.htm)	2200604		C00035	Adult and Pediatric							Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Assessments and Examinations.Other Clinical Data;Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Disease/Injury Related Events.Classification;Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics;Assessments and Examinations.Other Clinical Data	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics		N/A.N/A	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Core	Core	Core	Core	Core	Supplemental	Core	Core	Core	Supplemental	Core	Core	Core	Core		Core	Core	Core	Gender type	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core/FITBIR TBI Core	MedclHistCondSNOMEDCTCode	Medical history condition SNOMED CT code	Common Data Element		Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject	Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject	Alphanumeric	255	Free-Form Entry							Code each of the medical history conditions using SNOMED CT. Recommend collection at least during initial medical treatment. This element is recommended for Pediatric studies.	The verbatim text for the medical condition or disease reported in the medical history should be coded using SNOMED CT codes prior to data sharing. See SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html)	SNOMED CT code	Core_TBI	SNOMED CT Codes (http: //www.nlm.nih.gov/research/umls/Snomed/snomed_main.html)			C00313	Adult and Pediatric							Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History		Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History		Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	N/A.N/A	Participant/Subject History and Family History.General Health History		Core	Core	Core	Core	Core		Core	Core	Core		Core	Core	Core	Core	Core	Supplemental	Core		Medical history condition SNOMED CT code	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core/FITBIR TBI Core	MedclHistCondTxt	Medical history condition text	Common Data Element		Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history	Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history	Alphanumeric	4000	Free-Form Entry							ALS/GENERAL/MG/NMD/SMA: Record one Medical History term per line. See the data dictionary for additional information on coding the condition using SNOMED CT TBI: Recommend collection at least during initial medical treatment. This element is recommended for pediatric studies. SCI: Document the specific diagnosis for each pre-existing neuro-musculoskeletal condition and document the location/anatomic site if not obvious. Previous surgeries due to any of the conditions should also be documented with this element. Record each condition or surgery on separate lines. FA: Enter all significant medical history items, including surgeries, EXCEPT the problem/condition that is the focus of this study. Use only one line per description. STROKE: Record one Medical History term per line. Make sure to record if the following events are in the medical history which are Core items: Any stroke; Ischemic stroke; Hemorrhagic stroke; Hemorrhagic stroke type; 4) Transient ischemic attack (TIA); Carotid stenosis; Epilepsy/ Seizure disorder; Central nervous system infection; Dementia; Head trauma; Head trauma type; Atrial fibrillation (AF)/ flutter; Rheumatic heart disease MS: Record one Medical History term per line. Document the specific diagnosis for each pre-existing neuro-musculoskeletal condition and document the location/anatomic site if not obvious. Previous surgeries due to any of the conditions should also be documented with this element. Record each condition or surgery on separate lines. Make sure to record if the following events are in the medical history which are Core items: Any stroke; Ischemic stroke; Hemorrhagic stroke; Hemorrhagic stroke type; 4) Transient ischemic attack (TIA); Carotid stenosis; Epilepsy/ Seizure disorder; Central nervous system infection; Dementia; Head trauma; Head trauma type; Atrial fibrillation (AF)/ flutter; Rheumatic heart disease SCI: Record one Medical History term per line. Make sure to record if the following events are in the medical history which are Core items: Any stroke; Ischemic stroke; Hemorrhagic stroke; Hemorrhagic stroke type; 4) Transient ischemic attack (TIA); Carotid stenosis; Epilepsy/ Seizure disorder; Central nervous system infection; Dementia; Head trauma; Head trauma type; Atrial fibrillation (AF)/ flutter; Rheumatic heart disease	The verbatim text for the medical condition or disease reported in the medical history should be coded using SNOMED CT codes prior to aggregation or sharing.	Medical history condition text	Core_TBI	ALS/DMD/GENERAL/MG/NMD/SCI/SMA/STROKE/TBI: SNOMED CT Codes (http: //www.nlm.nih.gov/research/umls/Snomed/snomed_main.html) FA/MG: No references available	2003874		C00322	Adult and Pediatric							Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History		Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History		Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	Participant/Subject History and Family History.General Health History	N/A.N/A			Core	Core	Core	Core	Core		Core	Supplemental	Core		Supplemental	Core	Core	Supplemental	Supplemental	Supplemental			Medical history condition text	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core/FITBIR TBI Core	PGOSEScore	Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Score	Common Data Element		Score for the participant, as a part of the Pediatric Glasgow Outcome Scale - Extended (PGOSE).	Score for the participant, as a part of the Pediatric Glasgow Outcome Scale - Extended (PGOSE).	Numeric Values		Single Pre-Defined Value Selected			1;2;3;4;5;6;7;8	Upper Good Recovery (Upper GR);Lower Good Recovery (Lower GR);Upper Moderate Disability (Upper MD);Lower Moderate Disability (Lower MD);Upper Severe Disability (Upper SD);Lower Severe Disability (Lower SD);Vegetative State (VS);Death	1;2;3;4;5;6;7;8		Note: The scale presented here is not based on the original article. It has become common practice in clinical trial administration to use this modified version that places the scores in reverse order (i.e., good recovery = 1, moderate disability =2, etc.).		Glasgow Outcome Scale -Extended, Pediatric Revision	Core_TBI	Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6): 1126-39. Epub 2012 Apr 10.			C07434	Pediatric							Outcomes and End Points.Pediatric	Outcomes and End Points.Global Outcome														Core	Core	Core	Core	Core														Glasgow Outcome Scale Extended (GOS-E) Pediatric Revision	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core/FITBIR TBI Core	SexSubjectGenotypOTH	Sex participant or subject genotype other text	Common Data Element		The free-text field related to Sex participant or subject genotype type specifying other text. The difference between male and female, based upon the interactions between genes and between the genotype and the environment. Genotype is identified based on the individuals reproductive organs and functions assigned by chromosomal complement.	The free-text field related to Sex participant or subject genotype type specifying other text. Sex chromosomes of the participant/subject based upon genotyping	Alphanumeric	4000	Free-Form Entry							No instructions available	Added to TBI per meeting with FITBIR on 12/18/13.	Other, specify	Core_TBI	No references available			C18751	Adult and Pediatric							Participant/Subject Characteristics.Demographics;Protocol Experience.Participant/Subject Identification, Eligibility, and Enrollment	Participant/Subject Characteristics.Demographics							Participant/Subject Characteristics.Demographics		Participant/Subject Characteristics.Demographics					Core	Core	Core	Core	Core							Supplemental		Supplemental						NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core/FITBIR TBI Core	SexSubjectGenotypTyp	Sex participant or subject genotype type	Common Data Element		The difference between male and female, based upon the interactions between genes and between the genotype and the environment. Genotype is identified based on the individuals reproductive organs and functions assigned by chromosomal complement.	Sex chromosomes of the participant/subject based upon genotyping	Alphanumeric		Single Pre-Defined Value Selected			Other, specify;Unknown;Unspecified;XX;XXX;XXY;XY;XYY	Other, specify;Unknown;Undifferentiated/Indeterminant/Intersex;XX;XXX;XXY;XY;XYY	444;999;222;1;2;3;4;5		Choose only one	Added to TBI per meeting with FITBIR on 12/18/13.	What is the subject's sex or genotype?	Core_TBI	No references available			C17396	Adult and Pediatric							Protocol Experience.Participant/Subject Identification, Eligibility, and Enrollment;Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics							Participant/Subject Characteristics.Demographics		Participant/Subject Characteristics.Demographics					Core	Core	Core	Core	Core							Supplemental		Supplemental					Sex participant or subject type	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core/FITBIR TBI Core/NTRR V1	EthnUSACat	Ethnicity USA category	Common Data Element		Category of ethnicity the participant/subject most closely identifies with	Category of ethnicity the participant/subject most closely identifies with	Alphanumeric		Single Pre-Defined Value Selected			Hispanic or Latino;Not Hispanic or Latino;Not reported;Unknown	A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term "Spanish origin" can also be used in addition to "Hispanic or Latino".;A person not meeting the definition for Hispanic or Latino.;Not provided or available;Could not be determined or unsure	1;2;0;999		Choose one. Response is obtained by report of the participant/subject or caretaker. If more detailed characterizations of ethnicity are collected to enhance data quality and consistency, it is recommended that they be "collapsible" up to the two categories for reportable ethnicity, as needed for reporting to FDA under its guidance. Other regulatory bodies may expect the reporting of ethnicity values which more appropriately reflect the population of their areas (e.g., Japanese ancestry for MHLW reporting to Japan). These may be collected as an extension to the suggested code list.	The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 defines the minimum standard of basic racial and ethnic categories. (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, September 2005 - http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm)	What is the subject's ethnicity?	Core_TBI	The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget (OMB) Directive No. 15 defines the minimum standard of Core racial and ethnic categories. (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, September 2005 - http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm) Jorde LB and Wooding SP. Genetic variation, classification and "race". Nature Genetics. 2004;36(11):S28-S33. Bhopal R and Donaldson L. White, European, Western, Caucasian, or What? Inappropriate labeling in Research on Race, Ethnicity, and Health. Amer J of Publ Health. 1998;88:1303-1307.	2192217		C00020	Adult and Pediatric							Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics			Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Core	Core	Core	Core	Core	Core	Core	Core	Core	Core	Core	Core	Core	Core			Core	Core	Ethnicity USA category	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR General Core/FITBIR TBI Core/NTRR V1	RaceUSACat	Race USA category	Common Data Element		The patient's self declared racial origination, independent of ethnic origination, using OMB approved categories.	The patient's self declared racial origination, independent of ethnic origination, using OMB approved categories.	Alphanumeric		Multiple Pre-Defined Values Selected			American Indian or Alaska Native;Asian;Black or African-American;Native Hawaiian or Other Pacific Islander;Not Reported;Unknown;White	A person having origins in any of the original peoples of North, Central, or South America, and who maintains tribal affiliations or community attachment.;A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine Islands have been recorded as Pacific Islanders in previous data collection strategies.);A person having origins in any of the black racial groups of Africa.;A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.;Not provided or unavailable;Could not be determined or unsure;A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.	1;2;3;4;0;999;5		Choose all that apply. Response is obtained by report of the participant/subject or caretaker. Collecting information on race may not be allowed in some countries for concerns related to discrimination. In other countries, however, these concerns are considered a reason for recording race in order to guarantee equal access to care. Investigators receiving funding from the US National Institutes of Health (NIH) are required to report the number of subjects enrolled on an annual basis using the racial categories listed.	The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget (OMB) Directive No. 15 defines the minimum standard of basic racial and ethnic categories. (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm)	What is the subjectÃ¢Â€Â™s race (as defined by OMB)?	Core_TBI	The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget (OMB) Directive No. 15 defines the minimum standard of basic racial and ethnic categories. (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, September 2005 - http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm) Jorde LB and Wooding SP. Genetic variation, classification and "race". Nature Genetics. 2004;36(11):S28-S33. Bhopal R and Donaldson L. White, European, Western, Caucasian, or What? Inappropriate labeling in Research on Race, Ethnicity, and Health. Amer J of Publ Health. 1998;88:1303-1307.	2192199		C00030	Adult and Pediatric							Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics		Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics			Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics			Participant/Subject Characteristics.Demographics	Participant/Subject Characteristics.Demographics	Core	Core	Core	Core	Core		Exploratory	Core			Core	Core	Core	Core			Core	Core	Race USA category	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	EduPrimCaregiverYrCt	Education primary caregiver year count	Common Data Element		Number of years of education of the primary caregiver (age 5 and beyond).	Number of years of education of the primary caregiver (age 5 and beyond).	Numeric Values		Free-Form Entry	0	30				Year	No instructions available	In order to apply to international setting, this data element was made to supplement C00013	How many years of education does the parent, guardian, or caregiver have?	Core_TBI	No references available			C18614	Adult and Pediatric								Participant/Subject Characteristics.Social Status															Core	Core	Core	Core															NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	EduYrCt	Education year count	Common Data Element		Number of years of education completed (age 5 and beyond)	Number of years of education completed (age 5 and beyond)	Numeric Values		Free-Form Entry	0	30				Year	Choose the highest level attained by the participant/subject caBIG CDE Public ID = 3134878 For years completed, code the number of years attained (0-30 years), normed to someone moving full time at the usual pace, i.e. a year that was repeated counts as only 1 year and the usual single-year full-time load completed over several years counts as 1 year. Certificate and technical programs do NOT count no matter how specialized. The number of years of typical completion of the relevant program is counted. If the subject obtained their education outside the United States, ask about their educational system to estimate the correct coding - Internship, Residency, and Fellowship years are experiential training and do not count. Recommend collection at least on date of TBI.	Choose the highest level attained by the participant/subject	How many years of education does the subject have?	Core_TBI	No references available	3134878		C00015	Adult and Pediatric							Participant/Subject Characteristics.Social Status	Participant/Subject Characteristics.Social Status			Participant/Subject Characteristics.Social Status	Participant/Subject Characteristics.Social Status		Participant/Subject Characteristics.Social Status						Participant/Subject Characteristics.Social Status		Supplemental	Core	Core	Core	Core			Supplemental	Core		Supplemental						Core		Education level USA type	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	EmplmtExpndOTH	Employment expanded other text	Common Data Element		The free-text field related to Employment expanded status specifying other text. Status of participant/subjects current employment	The free-text field related to Employment expanded status specifying other text. Status of participant/subjects current employment	Alphanumeric	4000	Free-Form Entry							Choose one.	Prior TBI studies utilized the Employment Status data element for data capture	Other, specify	Core_TBI	National Health and Nutrition Examination Survey (http: //www.cdc.gov/nchs/nhanes.htm)			C18676	Adult and Pediatric								Participant/Subject Characteristics.Social Status															Core	Core	Core	Core															NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	EmplmtExpndStatus	Employment expanded status	Common Data Element		Status of participant/subjects current employment	Status of participant/subjects current employment	Alphanumeric		Single Pre-Defined Value Selected			Not in paid workforce;Other, specify;Sick leave or maternity leave;Special employment;Temporary/odd jobs/less than minimum wage jobs;Unable to obtain information;Unemployed;Unknown;Working 20-34 hrs/week, at least minimum wage;Working full time;Working less than 20 hrs/week, at least minimum wage	Not in paid workforce (including child, retired, student, homemaker, disabled pre-injury);Other, specify;Sick leave or maternity leave;Special employment (sheltered workshop, supportive employment, job coach);Temporary/odd jobs/less than minimum wage jobs;Unable to obtain information;Unemployed;Unknown;Working 20-34 hrs/week, at least minimum wage;Working full time (35 hrs or more/week, at least minimum wage);Working less than 20 hrs/week, at least minimum wage	1;444;3;4;5;6;7;999;9;10;11		Choose one.	Prior TBI studies utilized the Employment Status data element for data capture	What is the status of the subject's current employment?	Core_TBI	National Health and Nutrition Examination Survey (http: //www.cdc.gov/nchs/nhanes.htm)			C18658	Adult and Pediatric								Participant/Subject Characteristics.Social Status															Core	Core	Core	Core															NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	GCSEyeRespnsScale	Glasgow Coma Scale (GCS) - eye response scale	Common Data Element		Glasgow Coma Scale (GCS) - Best eye response (E). The GCS is a standardized instrument for assessing the level of consciousness. It evaluates three aspects of responsiveness: eye opening, motor response, verbal response.	Glasgow Coma Scale (GCS) - Best eye response (E). The GCS is a standardized instrument for assessing the level of consciousness. It evaluates three aspects of responsiveness: eye opening, motor response, verbal response.	Alphanumeric		Single Pre-Defined Value Selected			1;2;3;4;Unknown;Untestable	No eye opening;Eye opening to pain;Eye opening to speech/verbal command;Eyes open spontaneously;Unknown;Untestable	1;2;3;4;0;555		Choose one. This element should be collected along with the other elements from the Glasgow Coma Scale (GCS). Intubation and severe facial/eye swelling or damage make it impossible to test the verbal and eye responses. In these circumstances, the score is given as 1 with a modifier attached e.g. 'E1s' where 's' = swollen, or 'V1t' where t = tube. A composite might be 'GCS 5ts'. This would mean, for example, eyes closed because of swelling = 1, intubated = 1, leaving a motor score of 3 for 'abnormal flexion'. Often the 1 is left out, so the scale reads ES or VT.		Best eye response	Core_TBI	Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. Jul 1974;2(7872): 81-4. Marmarou A, Lu J, Butcher I, et al. Prognostic value of the Glasgow Coma Scale and pupil reactivity in traumatic brain injury assessed pre-hospital and on enrolment: an IMPACT analysis. J Neurotrauma. Feb 2007;24(2): 270-80. Stocchetti N, Pagan F, Calappi E, et al. Inaccurate early assessment of neurological severity in head injury. J Neurotrauma. Sep 2004: 21(9): 1131-40. Balestreri M, Czosnyka M, Chatfield DA, et al. Predictive value of Glasgow Coma Scale after brain trauma: change in trend over the past ten years. J Neurol Neurosurg Psychiatry. Jan 2004;75(1): 161-2.			C01000	Adult and Pediatric							Disease/Injury Related Events.History of Disease/Injury Event;Assessments and Examinations.Physical/Neurological Examination	Assessments and Examinations.Physical/Neurological Examination			Disease/Injury Related Events.History of Disease/Injury Event											Supplemental	Core	Core	Core	Core			Supplemental											GCS Eye response	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	GCSMotorRespnsScale	Glasgow Coma Scale (GCS) - motor response scale	Common Data Element		Glasgow Coma Scale (GCS) - Best motor response (M). The GCS is a standardized instrument for assessing the level of consciousness. It evaluates three aspects of responsiveness: eye opening, motor response, verbal response.	Glasgow Coma Scale (GCS) - Best motor response (M). The GCS is a standardized instrument for assessing the level of consciousness. It evaluates three aspects of responsiveness: eye opening, motor response, verbal response.	Alphanumeric		Single Pre-Defined Value Selected			1;2;3;4;5;6;Unknown;Untestable	No motor response;Abnormal extension/Extensor response;Abnormal flexion;Flexion withdrawal/withdraws from pain;Localizes pain;Obeys command;Unknown;Untestable	1;2;3;4;5;6;999;555		Choose one. This element should be collected along with the other elements from the Glasgow Coma Scale (GCS).		Best motor response	Core_TBI	Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. Jul 1974;2(7872): 81-4. Marmarou A, Lu J, Butcher I, et al. Prognostic value of the Glasgow Coma Scale and pupil reactivity in traumatic brain injury assessed pre-hospital and on enrolment: an IMPACT analysis. J Neurotrauma. Feb 2007;24(2): 270-80. Stocchetti N, Pagan F, Calappi E, et al. Inaccurate early assessment of neurological severity in head injury. J Neurotrauma. Sep 2004: 21(9): 1131-40. Balestreri M, Czosnyka M, Chatfield DA, et al. Predictive value of Glasgow Coma Scale after brain trauma: change in trend over the past ten years. J Neurol Neurosurg Psychiatry. Jan 2004;75(1): 161-2.			C01001	Adult and Pediatric							Assessments and Examinations.Physical/Neurological Examination;Disease/Injury Related Events.History of Disease/Injury Event	Assessments and Examinations.Physical/Neurological Examination;Disease/Injury Related Events.Classification			Disease/Injury Related Events.History of Disease/Injury Event											Supplemental	Core	Core	Core	Core			Supplemental											GCS Motor response	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	GCSTotalScore	Glasgow Coma Scale (GCS) - total score	Common Data Element		Glasgow Coma Scale (GCS) - Total Score. The GCS is a standardized instrument for assessing the level of consciousness. It evaluates three aspects of responsiveness: eye opening, motor response, verbal response. The total score is the sum of the scores for the three response types. (3-15)	Glasgow Coma Scale (GCS) - Total Score. The GCS is a standardized instrument for assessing the level of consciousness.	Alphanumeric		Single Pre-Defined Value Selected			10;11;12;13;14;15;3;4;5;6;7;8;9;Unknown;Untestable	10;11;12;13;14;15;3;4;5;6;7;8;9;Unknown;Untestable	10;11;12;13;14;15;3;4;5;6;7;8;9;999;555		This element should be collected along with the other elements from the Glasgow Coma Scale (GCS). The minimum possible score on the GCS is 3 and the maximum possible score is 15. http: //www.glasgowcomascale.org/faq/ *Dealing with missing information: There are various different strategies for dealing with information that is missing because of factors interfering with assessment such as those described above. 1. Assess, communicate and make decisions using the remaining components. Although guidelines are often expressed in terms of a total GCS score, the trend in whichever of the components (eye, motor or verbal) can be assessed is still valuable. 2. Do not use number to record missing component; use Not testable . 3. Do not report a total score when a component is Not Testable because the score will be low and this could be confusing to medical colleagues. This may also imply that the patient is more unwell than they actually are. 4. It is possible using statistical methods to estimate a missing component from the findings in the other components. This is probably more relevant to research than clinical practice.		GCS Total Score	Core_TBI	Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. Jul 1974;2(7872): 81-4. Marmarou A, Lu J, Butcher I, et al. Prognostic value of the Glasgow Coma Scale and pupil reactivity in traumatic brain injury assessed pre-hospital and on enrolment: an IMPACT analysis. J Neurotrauma. Feb 2007;24(2): 270-80. Stocchetti N, Pagan F, Calappi E, et al. Inaccurate early assessment of neurological severity in head injury. J Neurotrauma. Sep 2004: 21(9): 1131-40. Balestreri M, Czosnyka M, Chatfield DA, et al. Predictive value of Glasgow Coma Scale after brain trauma: change in trend over the past ten years. J Neurol Neurosurg Psychiatry. Jan 2004;75(1): 161-2.			C01016	Adult and Pediatric							Disease/Injury Related Events.History of Disease/Injury Event;Assessments and Examinations.Physical/Neurological Examination	Assessments and Examinations.Physical/Neurological Examination			Disease/Injury Related Events.History of Disease/Injury Event											Supplemental	Core	Core	Core	Core			Supplemental											GCS Total score	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	GCSVerbalRspnsScale	Glasgow Coma Scale (GCS) - verbal response scale	Common Data Element		Score that describes the participant's verbal response according to the Glasgow Coma Scale (GCS)	Score that describes the participant's verbal response according to the Glasgow Coma Scale (GCS)	Alphanumeric		Single Pre-Defined Value Selected			1;2;3;4;5;Unknown;Untestable	No verbal response/sounds;Incomprehensible sound;Inappropriate words;Confused;Oriented;Unknown;Untestable	1;2;3;4;5;0;555		Choose one. This element should be collected along with the other elements from the Glasgow Coma Scale (GCS). Intubation and severe facial/eye swelling or damage make it impossible to test the verbal and eye responses. In these circumstances, the score is given as 1 with a modifier attached e.g. 'E1S' where 's' = swollen, or 'V1t' where t = tube. A composite might be 'GCS 5tc'. This would mean, for example, eyes closed because of swelling = 1, intubated = 1, leaving a motor score of 3 for 'abnormal flexion'. Often the 1 is left out, so the scale reads Es or Vt.	When date/time data are prepared for aggregation or sharing they should be converted to the format specified by ISO 8601, YYYY-MM-DDThh:mm:ss.	Best verbal response	Core_TBI	Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. Jul 1974;2(7872): 81-4. Marmarou A, Lu J, Butcher I, et al. Prognostic value of the Glasgow Coma Scale and pupil reactivity in traumatic brain injury assessed pre-hospital and on enrolment: an IMPACT analysis. J Neurotrauma. Feb 2007;24(2): 270-80. Stocchetti N, Pagan F, Calappi E, et al. Inaccurate early assessment of neurological severity in head injury. J Neurotrauma. Sep 2004: 21(9): 1131-40. Balestreri M, Czosnyka M, Chatfield DA, et al. Predictive value of Glasgow Coma Scale after brain trauma: change in trend over the past ten years. J Neurol Neurosurg Psychiatry. Jan 2004;75(1): 161-2.			C01002	Adult and Pediatric							Disease/Injury Related Events.History of Disease/Injury Event;Assessments and Examinations.Physical/Neurological Examination	Assessments and Examinations.Physical/Neurological Examination			Disease/Injury Related Events.History of Disease/Injury Event											Supplemental	Core	Core	Core	Core			Supplemental											GCS Verbal response	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	GlasgowOutcomeScalExtScore	Glasgow Outcome Scale Extended (GOS-E) - Score	Common Data Element		Glasgow Outcome Scale Extended (1-8)	Glasgow Outcome Scale Extended (1-8)	Numeric Values		Single Pre-Defined Value Selected			1;2;3;4;5;6;7;8	Dead;Vegetative State;Lower Severe Disability;Upper Severe Disability;Lower Moderate Disability;Upper Moderate Disability;Lower Good Recovery;Upper Good Recovery	1;2;3;4;5;6;7;8		Scoring: The patient's overall rating is based on the lowest outcome category indicated on the scale. Refer to Wilson (1998) for further information concerning administration and scoring	Glasgow Outcome Scale Extended (GOS-E) - scale	Score	Core_TBI	Wilson JTL, Pettigrew LEL, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the Extended Glasgow Outcome Scale: Guidelines for their use. Journal of Neurotrauma 1998;15: 573-585.		GOSE112	C07194	Adult							Outcomes and End Points.Activities of Daily Living/Performance;Outcomes and End Points.Other Clinical Data	Outcomes and End Points.Global Outcome														Supplemental	Core	Core	Core	Core														Glasgow Outcome Scale Extended	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	InjElapsedTime	Injury elapsed time	Common Data Element		The elapsed time (in minutes) from the time of injury	The elapsed time (in minutes) from the time of injury	Numeric Values		Free-Form Entry	0					Minute	Indicate the time since injury occurred following definition provided per protocol. Note: Accurate determination of time since injury is critical for gauging patient progress and for assessing eligibility for acute phase studies. The need for TBI patients to be transferred from an initial receiving hospital to another hospital may delay definitive care and consequently impact outcome adversely, and longer transport times delay definitive treatment.			Core_TBI	No references available			C17404	Adult and Pediatric							Disease/Injury Related Events.History of Disease/Injury Event	Disease/Injury Related Events.History of Disease/Injury Event														Supplemental	Core	Core	Core	Core														Injury elapsed time	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	InjICDExtCauseCode	Injury ICD external cause code	Common Data Element		Code to classify the external cause of the injury	Code to classify the external cause of the injury	Alphanumeric	255	Free-Form Entry							Record as many as needed; please refer to http: //www.cdc.gov/nchs/icd.htm. Response is obtained from report by subject/participant (if possible), witnesses, first responders, family and/or medical records. The cause of injury is particularly important from an epidemiologic perspective, but may also be related to mechanism of injury and consequently type and extent of brain damage.	The cause of injury is particularly important from an epidemiologic perspective, but may also be related to mechanism of injury and consequently type and extent of brain damage. Data Sharing Instructions: Cause of injury data should be coded using ICD external cause of injury codes prior to aggregation or sharing.	and or ICD 9 CM e codes	Core_TBI	Butcher I, McHugh GS, Lu J, et al. Prognostic value of cause of injury in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2): 281-286. http: //www.icd9data.com			C05421	Adult and Pediatric							Disease/Injury Related Events.History of Disease/Injury Event	Disease/Injury Related Events.History of Disease/Injury Event														Supplemental	Core	Core	Core	Core														Injury ICD-9-CM external cause code	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	LOCDurRang	Loss of consciousness duration range	Common Data Element		The range of duration of loss of consciousness the participant/subject experienced	The range of duration of loss of consciousness the participant/subject experienced	Alphanumeric		Single Pre-Defined Value Selected			1-24 hours;1-29 minutes;14-20 days;1-5 hours;1-7 days;<1 minute;21-28 days;24 hours to 3 days;29-59 days;30-59 minutes;4-6 days;60-89 days;6-24 hours;>7 days;8-13 days;90 or more days;None;No return of consciousness prior to death or discharge;Unknown	1-24 hours;1-29 minutes;14-20 days;1-5 hours;1-7 days;<1 minute;21-28 days;24 hours to 3 days;29-59 days;30-59 minutes;4-6 days;60-89 days;6-24 hours;>7 days;8-13 days;90 or more days;None;No return of consciousness prior to death or discharge;Unknown	1;2;3;4;5;6;7;8;9;10;11;12;13;14;15;16;0;18;999		Choose one. Response is obtained from report by subject/participant or clinician. If clinically monitored, GCS or other assessment tool recommended.		Duration of loss of consciousness	Core_TBI	Menon D.K., Schwab K., Wright D.W., Maas A.I. (2010). Demographics and Clinical Assessment Working Group of the International and Interagency Initiative toward Common Data Elements for Research on Traumatic Brain Injury and Psychological Health. Position statement: definition of traumatic brain injury. Arch Phys Med Rehabil. 91(11): 1637-40. [DOI: 10.1016/j.apmr.2010.05.017] Carroll L. J., Cassidy J. D., Holm L., Kraus J., & Coronado V. G. (2004). Methodological issues and research recommendations for mild traumatic brain injury: the WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. Journal of Rehabilitation Medicine, (Suppl. 43), 113-125. Center for Disease Control and Prevention. (2003). Report to Congress on mild traumatic brain injury in the United States: Steps to prevent a serious public health problem. Atlanta: Centers for Disease Control and Prevention. Department of Veterans Affairs Office of Quality and Performance and Department of Defense Quality Management Directorate, U.S. Army Medical Command. (2009). VA/DoD clinical practice guidelines for management of concussion/mild traumatic brain injury. (www.healthquality.va.gov/mtbi/concussion_mtbi_full_1_0.pdf). Mild Traumatic Brain Injury Committee, A. C. o. R. M., Head Injury Interdisciplinary Special Interest Group. (1993). Definition of mild traumatic brain injury. Journal of Head Trauma Rehabilitation, 8(3): 86-87. American Academy of Pediatrics. (1999). The management of minor closed head injury in children. Pediatrics 104: 1407-1415. World Health Organization. (1992). The ICD-10 classification of mental and behavioral disorders: clinical descriptions and diagnostic guidelines. Geneva: World Health Organization. Yeates K.O. & Taylor H.G. (2005). Neurobehavioural outcomes of mild head injury in children and adolescents. Pediatric Rehabilitation, 8(1): 5-16. Ruff R.M., Iverson G.L., Barth J.T., Bush S.S., Broshek D.K., and the NAN Policy and Planning Committee (2009). Recommendations for Diagnosing a Mild Traumatic Brain Injury: A National Academy of Neuropsychology Education Paper. Archives of Clinical Neuropsychology 24: 3-10.			C01053	Adult and Pediatric							Assessments and Examinations.Physical/Neurological Examination	Assessments and Examinations.Physical/Neurological Examination														Supplemental	Core	Core	Core	Core														Loss of consciousness duration range	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	PGCSEyeRespnsScore	Pediatric Glasgow Coma Scale (PGCS) - eye response score	Common Data Element		Score for the participant's eye response according to the Pediatric Glasgow Coma Scale (PGCS) if the participant is under the age of 18.	Score for the participant's eye response according to the Pediatric Glasgow Coma Scale (PGCS) if the participant is under the age of 18.	Alphanumeric		Single Pre-Defined Value Selected			1;2;3;4;Unknown;Untestable	No eye opening;Eye opening to pain;Eye opening to speech;Eyes open spontaneously;Unknown;Untestable	1;2;3;4;0;555		Choose one. Add date and time stamp for when assessed. GCS should be collected as early as possible following injury. In certain sports studies where this is difficult to collect, investigators should justify why they aren't collecting this CDE.		Best eye response	Core_TBI	Marcin J and Pollack M. (2002). Triage scoring systems, severity of illness measures, and mortality prediction models in pediatric trauma. Crit Care Med. 30: 457-467.			C01020	Pediatric							Assessments and Examinations.Physical/Neurological Examination	Assessments and Examinations.Physical/Neurological Examination														Supplemental	Core	Core	Core	Core														GCS-Pediatric Eye response	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	PGCSMotorRespnsScore	Pediatric Glasgow Coma Scale (PGCS) - motor response score	Common Data Element		Score for the participant's motor response according to the Pediatric Glasgow Coma Scale (PGCS) if the participant is under the age of 18.	Score for the participant's motor response according to the Pediatric Glasgow Coma Scale (PGCS) if the participant is under the age of 18.	Alphanumeric		Single Pre-Defined Value Selected			1;2;3;4;5;6;Unknown;Untestable	No motor response;Extension to pain;Flexion to pain;Withdrawal from pain;Localizing pain;Obeys commands;Unknown;Untestable	1;2;3;4;5;6;999;555		Choose one. Add date and time stamp for when assessed. GCS should be collected as early as possible following injury. In certain sports studies where this is difficult to collect, investigators should justify why they aren't collecting this CDE.		Motor response	Core_TBI	Marcin J and Pollack M. (2002). Triage scoring systems, severity of illness measures, and mortality prediction models in pediatric trauma. Crit Care Med. 30: S457-S467.			C01021	Pediatric							Assessments and Examinations.Physical/Neurological Examination	Disease/Injury Related Events.Classification;Assessments and Examinations.Physical/Neurological Examination														Supplemental	Core	Core	Core	Core														GCS-Pediatric Motor response	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	PGCSTotalScore	Pediatric Glasgow Coma Scale (PGCS) - total score	Common Data Element		Score for the participant's total Pediatric Glasgow Coma Scale (PGCS) score of the 3 tests, eye, motor, and verbal responses. A score of less than 9 would indicate that that participant is in a severe coma while a score of greater than 9 is a mild or no coma at all.	The participant's total Pediatric Glasgow Coma Scale (PGCS) score of 3 tests, eye, motor, and verbal responses. A score of less than 9 would indicate that that participant is in a severe coma; a score of greater than 9 is a mild or no coma at all.	Alphanumeric		Single Pre-Defined Value Selected			10;11;12;13;14;15;3;4;5;6;7;8;9;Unknown;Untestable	10;11;12;13;14;15;3;4;5;6;7;8;9;Unknown;Untestable	10;11;12;13;14;15;3;4;5;6;7;8;9;999;555		3-15 calculated field. Add date and time stamp for when assessed. GCS should be collected as early as possible following injury. In certain sports studies where this is difficult to collect, investigators should justify why they aren't collecting this CDE.		Total score	Core_TBI	Marcin J and Pollack M. (2002). Triage scoring systems, severity of illness measures, and mortality prediction models in pediatric trauma. Crit Care Med. 30: 457-467.			C01017	Pediatric							Assessments and Examinations.Physical/Neurological Examination	Assessments and Examinations.Physical/Neurological Examination														Supplemental	Core	Core	Core	Core														GCS-Pediatric Total score	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	PGCSVerbalRespnsScore	Pediatric Glasgow Coma Scale (PGCS) - verbal response score	Common Data Element		Score for the participant's verbal response according to the Pediatric Glasgow Coma Scale (PGCS) if the participant is under the age of 18.	Score for the participant's verbal response according to the Pediatric Glasgow Coma Scale (PGCS) if the participant is under the age of 18.	Alphanumeric		Single Pre-Defined Value Selected			1;2;3;4;5;Unknown;Untestable	No vocal response;Inconsolable, agitated;Inconsistently consolable, moaning;Cried, but it consolable, inappropriate interactions;Smiles, oriented to sounds, follows objects, interacts;Unknown;Untestable	1;2;3;4;5;999;555		Choose one. Add date and time stamp for when assessed. GCS should be collected as early as possible following injury. In certain sports studies where this is difficult to collect, investigators should justify why they aren't collecting this CDE.		Verbal response	Core_TBI	Marcin J and Pollack M. (2002). Triage scoring systems, severity of illness measures, and mortality prediction models in pediatric trauma. Crit Care Med. 30: S457-S467.			C01022	Pediatric							Assessments and Examinations.Physical/Neurological Examination	Assessments and Examinations.Physical/Neurological Examination														Supplemental	Core	Core	Core	Core														GCS-Pediatric Verbal response	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	PstTraumAmnsDurRang	Post traumatic amnesia duration range	Common Data Element		The range of duration of post-traumatic amnesia the participant/subject experienced	The range of duration of post-traumatic amnesia the participant/subject experienced	Alphanumeric		Single Pre-Defined Value Selected			1-24 hours;1-29 minutes;1-7 days;<1 minute;>24 hours;30-59 minutes;30 minutes to 24 hours;>7 days;N/A;None;Unknown	1-24 hours;1-29 minutes;1-7 days;<1 minute;>24 hours;30-59 minutes;30 minutes to 24 hours;>7 days;N/A (e.g., death);None;Unknown	5;2;7;1;6;3;4;8;777;0;999		Choose one.		Duration of post-traumatic amnesia	Core_TBI	Menon D.K., Schwab K., Wright D.W., Maas A.I. (2010). Demographics and Clinical Assessment Working Group of the International and Interagency Initiative toward Common Data Elements for Research on Traumatic Brain Injury and Psychological Health. Position statement: definition of traumatic brain injury. Arch Phys Med Rehabil. 91(11): 1637-40. [DOI: 10.1016/j.apmr.2010.05.017] Carroll L. J., Cassidy J. D., Holm L., Kraus J., & Coronado V. G. (2004). Methodological issues and research recommendations for mild traumatic brain injury: the WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. Journal of Rehabilitation Medicine, (Suppl. 43), 113-125. Center for Disease Control and Prevention. (2003). Report to Congress on mild traumatic brain injury in the United States: Steps to prevent a serious public health problem. Atlanta: Centers for Disease Control and Prevention. Department of Veterans Affairs Office of Quality and Performance and Department of Defense Quality Management Directorate, U.S. Army Medical Command. (2009). VA/DoD clinical practice guidelines for management of concussion/mild traumatic brain injury. (www.healthquality.va.gov/mtbi/concussion_mtbi_full_1_0.pdf). Mild Traumatic Brain Injury Committee, A. C. o. R. M., Head Injury Interdisciplinary Special Interest Group. (1993). Definition of mild traumatic brain injury. Journal of Head Trauma Rehabilitation, 8(3): 86-87. American Academy of Pediatrics. (1999). The management of minor closed head injury in children. Pediatrics 104: 1407-1415. World Health Organization. (1992). The ICD-10 classification of mental and behavioural disorders: clinical descriptions and diagnostic guidelines. Geneva: World Health Organization. Yeates K.O. & Taylor H.G. (2005). Neurobehavioural outcomes of mild head injury in children and adolescents. Pediatric Rehabilitation, 8(1): 5-16. Ruff R.M., Iverson G.L., Barth J.T., Bush S.S., Broshek D.K., and the NAN Policy and Planning Committee (2009). Recommendations for Diagnosing a Mild Traumatic Brain Injury: A National Academy of Neuropsychology Education Paper. Archives of Clinical Neuropsychology 24: 3-10.			C01055	Adult and Pediatric								Assessments and Examinations.Physical/Neurological Examination															Core	Core	Core	Core														Post traumatic amnesia duration range	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
FITBIR TBI Core	SAHStatus	Subarachnoid hemorrhage indicator	Common Data Element		Indicator of macroscopic blood located between the brain surface and the arachnoid membrane. On CT and MR, the blood in this location will follow the contour of the sulci and cisterns. Acute SAH is hyperdense on CT and hyperintense on FLAIR MR imaging.	Indicator of macroscopic blood located between the brain surface and the arachnoid membrane. On CT and MR, the blood in this location will follow the contour of the sulci and cisterns. Acute SAH is hyperdense on CT and hyperintense on FLAIR MR imaging.	Alphanumeric		Single Pre-Defined Value Selected			Absent;Indeterminate;Premorbid;Present	Absent;Indeterminate;Premorbid (when applicable);Present	2;0;;3		STROKE:Contains data elements collected when an imaging study is performed to measure parenchyma; data recorded attempt to divide the strokes into ischemic or hemorrhagic subtypes, as distinction of hemorrhage versus infarction is the initial critical branch point in acute stroke triage. (Examples of CDEs included: Acute infarcts present; Planimetic acute ischemic lesion volume; and Acute hematoma present) TBI:Choose one.	When date/time data are prepared for aggregation or sharing they should be converted to the format specified by ISO 8601, YYYY-MM-DDThh:mm:ss. ISO 8601 - http://www.iso.org/iso/iso_catalogue.htm	Subarachnoid hemorrhage	Core_TBI	TBI/STROKE:Duhaime AC, Gean AD, Haacke EM, Hicks R, Wintermark M, Mukherjee P, Brody D, Latour L, Riedy G; Common Data Elements Neuroimaging Working Group Members, Pediatric Working Group Members. Common data elements in radiologic imaging of traumatic brain injury. Arch Phys Med Rehabil. 2010 Nov;91(11):1661-6. [DOI: 10.1016/j.apmr.2010.07.238] Haacke, E.M., Duhaime, A.C., Gean, A.D., Riedy, G., Wintermark, M., Mukherjee, P., Brody, D.L., DeGraba, T., Duncan, T.D., and Elovic, E. (2010). Common data elements in radiologic imaging of traumatic brain injury. Journal of Magnetic Resonance Imaging 32, 516-543, DOI:10.1002/jmri.22259			C02469	Adult and Pediatric							Assessments and Examinations.Imaging Diagnostics	Disease/Injury Related Events.Classification;Assessments and Examinations.Imaging Diagnostics			Assessments and Examinations.Imaging Diagnostics											Supplemental	Core	Core	Core	Core			Supplemental											Subarachnoid hemorrhage indicator	NIH/CIT/BRICS	Olga Vovk	olga.vovk@nih.gov	NIH/NINDS	NINDSCDE	NINDSCDE@emmes.com
NTRR v1	AgeYears	Age in years	Common Data Element	1	Value for participant's subject age, calculated as elapsed time since the birth of the participant/subject in years. The subjects age is typically recorded to the nearest full year completed, e.g. 11 years and 6 months should be recorded as 11 years	Value for participant's subject age recorded in years.	Numeric Values		Free-Form Entry	0	150					The subject's age is typically recorded to the nearest full year completed, e.g. 11 years and 6 months should be recorded as 11 years. For subject's which are under 1 year old, use decimal points and use the following convention- record 1 month as 0.083 (1/12), 2 months as 0.166 (2/12), 3 months as 0.25 (3/12), 4 months as 0.333 (4/12), 5 months as 0.416 (5/12), 6 months as 0.5 (6/12), 7 months as 0.583 (7/12), 8 months as 0.666 (8/12), 9 months as 0.75 (9/12), 10 months as 0.833 (10/12), 11 months as 0.916 (11/12) and 12 months as 1 year. For the individuals 90 or older, in order to preserve PII, please submit "150" and make a note this in the "general notes" column.		Subject's age (recorded in years):		No references available				Adult and Pediatric	Participant/Subject Characteristics.Demographics	Core	Core	Core	Core	Core																																			National Trauma Institute			National Trauma Institute			2018-06-21	2018-06-29	Published
NTRR v1	AISBodyRegion	Abbreviated injury scale (AIS) - Body region	Common Data Element	1	The six body regions assessed with the 6 point intermediate ordinal severuty scale	The six body regions assessed with the 6 point intermediate ordinal severuty scale	Alphanumeric		Single Pre-Defined Value Selected			Abdomen;Chest;External;Extremity;Face;Head/Neck	4=Abdomen;3=Chest;6=External;5=Extremity;2=Face;1=Head/Neck	4;3;6;5;2;1		Choose one. For each AISInjurySeverityScore value, select the corresponding ISS body region								Adult and Pediatric	Disease/Injury Related Events.History of Disease/Injury Event	Core	Core	Core	Core	Core																																			National Trauma Institute			NINDS			2018-06-21	2018-06-29	Published
NTRR v1	AISDictionaryVersionTyp	Abbreviated injury scale (AIS) - Dictionary version type	Common Data Element	1	A type/version of the Abbreviated Injury Scale (AIS) dictionary used to assess the injury	A type/version of the Abbreviated Injury Scale (AIS) dictionary used to assess the injury	Alphanumeric		Single Pre-Defined Value Selected			AIS Military;AIS Revision 1990 Update 1998;AIS Revision 2005;AIS Revision 2005 Update 2008;AIS Revision 2015;AIS revison 1990	AIS Military;AIS Revision 1990 Update 1998;AIS Revision 2005;AIS Revision 2005 Update 2008;AIS Revision 2015;AIS Revision 1990	1;5;4;3;2;6		Choose one. Use AIS user manual to find out the version. Recommend using the most recent version. AIS dictionaries developed earlier than 1990 are not recommended for use in this data collection	FITBIR element	Version of Abbreviated injury scale (AIS) dictionary	Injury;AIS;MaxAIS;injury					Adult and Pediatric	Disease/Injury Related Events.History of Disease/Injury Event	Core	Core	Core	Core	Core																																			National Trauma Institute			FITBIR			2018-06-21	2018-06-29	Published
NTRR v1	AISInjuryDesriptionTxt	Abbreviated injury scale (AIS) - injury clinical description text	Common Data Element	1	A clinical description of the subject injury(ies) from the medical documentation, as part of Abbreviated Injury Scale (AIS). The injury should preferably be described in the Abbreviated injury Scale code controlled vocabulary terms.	A clinical description of the subject injury(ies) from the medical documentation, as part of Abbreviated Injury Scale (AIS). The injury should preferably be described in the Abbreviated injury Scale code controlled vocabulary terms.	Alphanumeric	4000	Free-Form Entry							For each combination of values recorded in AISBodyRegionChapterCat-AISInjurySeverityScore,enter the injury description from the medical documentation. This description is used to code the injury in AIS Code and desribes the precise injury. The injury descriptor in AIS code (refer to AISCode CDE) comprises the six digits to the left of the dot; this pre-dot code contains values indicating AIS body region injured captured in AISBodyRegionChapterCat and the rest of information, such as, type of structure injured, specific anatomic structure injured, and level of injury, which should be entered in this DE. The injury is described in the pre-dot vocabulary terms for positions 2-6. Using controlled vocabulary from the corresponding version of AIS dictionary is highly recommended. Refer to AISCode for the corresponding AIS code. Consult the corresponding version of AIS dictionary for legal values		AISCode pre-dot related text for code postions 2-6						Adult and Pediatric	Disease/Injury Related Events.History of Disease/Injury Event	Core	Core	Core	Core	Core																																			National Trauma Institute			NINDS			2018-06-21	2018-06-29	Published
NTRR v1	AISInjurySeverityScore	Abbreviated injury scale (AIS) - Injury severity score	Common Data Element	1	An injury severity score (AIS) code, as part of the Abbreviated injury scale (AIS) code	An injury severity score (AIS) code, as part of the Abbreviated injury scale (AIS) code	Alphanumeric		Single Pre-Defined Value Selected			1;2;3;4;5;6;9	1=Minor;2=Moderate;3=Serious;4=Severe;5=Critical;6=Maximal (currently untreatable);9=Unknown severity	1;2;3;4;5;6;9		For each body region, select the corresponding injury severity score.		AIS Injury Severity						Adult and Pediatric	Disease/Injury Related Events.History of Disease/Injury Event	Core	Core	Core	Core	Core																																			National Trauma Institute			NINDS			2018-06-21	2018-06-29	Published
NTRR v1	AISPreDot	Abbreviated Injury Score (AIS) - Predot	Common Data Element	1	The abbreviated injury scale pre-dot codes that reflect the paitent's injuries	The abbreviated injury scale pre-dot codes that reflect the patient's injuries	Alphanumeric	6	Free-Form Entry							Enter the 6 digit predate code for every patient injury								Adult and Pediatric	Disease/Injury Related Events.Classification	Core	Core	Core	Core	Core																																			National Trauma Institute			AAAM			2018-06-21	2018-06-29	Published
NTRR v1	Comorbidity	Comorbidities	Common Data Element	1		The pre-existing co-morbid factors of the participant/subject	Alphanumeric		Multiple Pre-Defined Values Selected			add/adhd;advanced directive limiting care;alcohol use disorder;angina pectoris;anticoagulant therapy;bleeding disorder;cerebrovascular aneurysm;chronic obstructive pulmonary disease;chronic renal failure;cirrhosis;congenital anomalies;congestive heart failure;currently receiving chemotherapy for cancer;current smoker;dementia;diabetes mellitus;disseminated cancer;functionally dependent health status;hypertension;Mental/personality disorder;myocardial infarction;other;peripheral artery disease;prematurity;steroid use;substance abuse disorder	1=add/adhd;2=advanced directive limiting care;3-alcohol use disorder;4=angina pectoris;5=anticoagulant therapy;6=bleeding disorder;7=cerebrovascular aneurysm;8=chronic obstructive pulmonary disease;9=chronic renal failure;10=cirrhosis;11=congenital anomalies;12=congestive heart failure;13=currently receiving chemotherapy for cancer;14=current smoker;15=dementia;16=diabetes mellitus;17=disseminated cancer;18=functionally dependent health status;19=hypertension;20=mental/personality disorder;21=myocardial infarction;999-other;22=peripheral artery disease;23=prematurity;24=steroid use;25=substance abuse disorder	1;2;3;4;5;6;7;8;9;10;11;12;13;14;15;16;17;18;19;20;21;999;22;23;24;25										Adult and Pediatric	Participant/Subject History and Family History.General Health History	Core	Core	Core	Core	Core																																			National Trauma Institute			NTDS			2018-06-21	2018-06-29	Published
NTRR v1	ComorbidityOTH	Comorbidity Other	Common Data Element	1		Other comorbid conditions not included in list.	Alphanumeric	300	Free-Form Entry															Adult and Pediatric	Participant/Subject History and Family History.General Health History	Core	Core	Core	Core	Core																																			National Trauma Institute			National Trauma Institute			2018-06-21	2018-06-29	Published
NTRR v1	GeneralNotesTxt	General notes text	Common Data Element	1	General notes	General notes	Alphanumeric	4000	Free-Form Entry							Use this field to capture additional information	CDISC variables: COREF, COVAL, COEVAL, COEVALID, CODTC, CODY.	Additional information (if any):		No references available				Adult and Pediatric	Participant/Subject Characteristics.Demographics	Core	Core	Core	Core	Core																																			National Trauma Institute			National Trauma Institute			2018-06-21	2018-06-29	Published
NTRR v1	ICDVersion	International Classification of Disease Version	Common Data Element	1	A version of the International Classification of Disease coding system	A version of the International Classification of Diseases coding system	Alphanumeric		Single Pre-Defined Value Selected			ICD-10;ICD-9-CM	ICD-10;ICD-9-CM	2;1										Adult and Pediatric	Disease/Injury Related Events.History of Disease/Injury Event	Core	Core	Core	Core	Core																																			National Trauma Institute			ICD			2018-06-21	2018-06-29	Published
NTRR v1	InjICDExtCauseCode	Injury ICD external cause code	Common Data Element	1	Code to classify the external cause of injury	Code to classify the external cause of injury	Alphanumeric	255	Free-Form Entry							Record as many as needed; please refer to http: //www.cdc.gov/nchs/icd.htm. Response is obtained from report by subject/participant (if possible), witnesses, first responders, family and/or medical records. The cause of injury is particularly important from an epidemiologic perspective, but may also be related to mechanism of injury and consequently type and extent of brain damage.ÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂ		Code to classify the external cause of the injury						Adult and Pediatric	Disease/Injury Related Events.History of Disease/Injury Event	Core	Core	Core	Core	Core																																			National Trauma Institute			NINDS			2018-06-21	2018-06-29	Published
NTRR v1	InjuryDateTime	Injury Date and Time	Common Data Element	1		Date and time the participant/subject was injured	Date or Date & Time		Free-Form Entry							Record the date and time the patient was injured.		What is the date and time the patient was injured?	Injury;injury					Adult and Pediatric	Participant/Subject Characteristics.Demographics	Core	Core	Core	Core	Core																																			National Trauma Institute			National Trauma Institute			2018-06-21	2018-06-29	Published
NTRR v1	ISS	Injury Severity Score	Common Data Element	1	Score measured by injury severity score (ISS)	Score measured by injury severity score (ISS)	Numeric Values		Free-Form Entry	1	75						NLM KBd7zS0k_fv v3; NINDS C05451 v3	ISS	ISS					Adult and Pediatric	Disease/Injury Related Events.Classification	Core	Core	Core	Core	Core																																			National Trauma Institute			NINDS			2018-06-21	2018-06-29	Published
NTRR v1	Person_Sex	Person Sex	Common Data Element	1	The assemblage of physical properties or qualities by which male is distinguished from female	The assemblage of physical properties or qualities by which male is distinguished from female	Alphanumeric		Single Pre-Defined Value Selected			A;F;M;U	A rare congenital abnormality in which the infant's external genitalia do not have the typical appearance of a male's or female's genitalia.;A person who belongs to the sex that normally produces ova. The term is used to indicate biological sex distinctions, or cultural gender role distinctions, or both.;A person who belongs to the sex that normally produces sperm. The term is used to indicate biological sex distinctions, cultural gender role distinctions, or both.;Not known, not observed, not recorded, or refused.	;;;										Adult and Pediatric	Participant/Subject Characteristics.Demographics	Core																																							National Trauma Institute			NLM			2019-08-07	2019-10-07	Published
NTRR v1	Unique_ID	Unique Identifier	Common Data Element	1	A Unique Identifier created by the NTRR system (Pseudo GUID or GUID)	A Unique Identifier created by the NTRR system (Pseudo GUID or GUID)	GUID		Free-Form Entry							Enter the Unique Identifier created by the NTRR system (Pseudo GUID or GUID)		What is the Unique Identifier created by the NTRR system f(Pseudo GUID or GUID) or this subject?						Adult and Pediatric	Participant/Subject Characteristics.Demographics	Core	Core	Core	Core	Core																																			National Trauma Institute			National Tauma Institute			2019-12-09	2019-12-09	Draft

Download NTRR CDE definitions

There are 20 NTRR v1 Core CDEs that are not a part of the FITBIR Core or FITBIR TBI Core. These CDEs have been mapped to other FITBIR Data Elements – comparator matches are provided in the table below.

NTRR v1 Core CDE			Mapped FITBIR CDE
Variable Name	Title	Definition	Variable Name	Title	Definition
AgeYears	Age in years	Value for participant's subject age, calculated as elapsed time since the birth of the participant/subject in years. The subjects age is typically recorded to the nearest full year completed, e.g. 11 years and 6 months should be recorded as 11 years	AgeYrs	Age in years	Value for participant's subject age recorded in years.
AISBodyRegion	Abbreviated injury scale (AIS) - Body region	The six body regions assessed with the 6 point intermediate ordinal severuty scale	AISBodyRegionChapterCat	Abbreviated injury scale (AIS) - Body region category	Category of body region assessed by Abbreviated Injury Scale (AIS)
AISDictionaryVersionTyp	Abbreviated injury scale (AIS) - Dictionary version type	A type/version of the Abbreviated Injury Scale (AIS) dictionary used to assess the injury	AISDictionaryVersionTyp	Abbreviated injury scale (AIS) - Dictionary version type	A type/version of the Abbreviated Injury Scale (AIS) dictionary used to access the injury
AISInjuryDescriptionTxt	Abbreviated injury scale (AIS) - injury clinical description text	A clinical description of the subject injury(ies) from the medical documentation, as part of Abbreviated Injury Scale (AIS). The injury should preferably be described in the Abbreviated injury Scale code controlled vocabulary terms.	AISInjuryDescriptionTxt	Abbreviated injury scale (AIS) - Injury clinical description text	A clinical description of the subject injury(ies) from the medical documentation, as part of Abbreviated Injury Scale (AIS). The injury should preferably be described in the Abbreviated Injury Scale code controlled vocabulary terms.
AISInjurySeverityScore	Abbreviated injury scale (AIS) - Injury severity score	An injury severity score (AIS) code, as part of the Abbreviated injury scale (AIS) code	AISInjurySeverityScore	Abbreviated injury scale (AIS) - Injury severity score	An injury severity score (AIS code), as part of Abbreviated injury scale (AIS) code
AISPreDot	Abbreviated Injury Score (AIS) - Predot	The abbreviated injury scale pre-dot codes that reflect the patient's injuries	AISCode	Abbreviated injury scale (AIS) - Code	Abbreviated injury scale (AIS) code including pre-dot and post-dot numeric codes as recorded according to the specified version of AIS dictionary (AISDictionaryVersion)
ComorbidityOTH	Comorbidity Other		MedHistCondoOTH	Medical history condition other text	Pre-specified medical condition/disease asked about when collecting the medical histroy from the particpant/subject or found documented in the medical record
GeneralNotesTxt	General notes text	General notes	GeneralNotesTxt	General notes text	General notes
ICDVersion	International Classification of Disease Version	A version of the International Classification of Disease coding system	ICDRevNumber	ICD revision number	Number of the International Classification of Diseases (ICD) used to obtain the code
InjICDExtCauseCode	Injury ICD external cause code	Code to classify the external cause of injury	InjICDExtCauseCode	Injury ICD external cause code	Code to classify the external cause of the injury
InjuryDateTime	Injury Date and Time		InjDateTime	Injury date time	Date (and time, if applicable and known) of injury
ISS	Injury Severity Score	Score measured by injury severity score (ISS)	InjSeverScore	Injury severity score	Score measured by injury severity score (ISS)
Person_Sex	Person Sex	The assemblage of physical properties or qualities by which male is distinguished from female	GenderTyp	Gender Type	Self-reported gender of the participant/subject. Gender is the socially constructed identity of sex.
Person_Sex	Person Sex		NPSEX	Subject's sex	Subject's sex
Unique_ID	Unique Identifier	A Unique Identifier created by the NTRR system (Pseudo GUID or GUID)	GUID	GUID	Global Unique ID which uniquely identifies a subject

An analysis of the data structures for CDEs in NTRR v1 and FITBIR identified differences in attribute collection. The tables below provide the attributes reported for each data dictionary.

Attributes common for both	Domains	Classifications
FITBIR & NTRR	FITBIR	FITBIR
variable name	general (for all diseases)	administrative status
title	traumatic brain injury	acute hospitalized
element type	traumatic brain injury	concussion/mild TBI
version	traumatic brain injury	epidemiology
definition	traumatic brain injury	moderate/severe TBI: rehabilitation
short description	Parkinson's disease	Parkinson's disease
datatype	Friedreich's ataxia	Friedreich's ataxia
maximum character quantity	stroke	stroke
input restriction	amyotrophic lateral sclerosis	amyotrophic lateral sclerosis
minimum value	Huntington's disease	Huntington's disease
maximum value	multiple sclerosis	multiple sclerosis
data element concept identifiers	neuromuscular diseases	neuromuscular diseases
data element concept names	myasthenia gravis	myasthenia gravis
data element terminology sources	spinal muscular atrophy	spinal muscular atrophy
permissible values	Duchenne muscular dystrophy/Becker muscular dystrophy	Duchenne muscular dystrophy/Becker muscular dystrophy
permissible value descriptions	congenital muscular dystrophy	congenital muscular dystrophy
permissible value output codes	spinal cord injury	spinal cord injury
permissible value concept identifiers	headache	headache
permissible value concept names	epilepsy	epilepsy
permissible value terminology sources	NTRR	NTRR
unit of measure	trauma	Epidemiology
guidelines/instructions	trauma	Pre-Hospital
notes	trauma	Acute Hospital
preferred question text	trauma	Rehabilitation/Outcome
keywords
references
population.all
historical notes
Label(s)
see also
submitting organization name
submitting contact name
submitting contact information
effective date
until date
steward organization name
steward contact name
steward contact information
creation date
last change date
administrative status

The National Trauma Research Repository (NTRR) is being integrated with FITBIR, and the platform will be available to investigators for upload of data from your trauma investigations and download of aggregated trauma research data sets for secondary analyses. The Coalition for National Trauma Research (CNTR) is gathering comments and suggestions regarding the Trauma Core Common Data Elements (CDEs) to be required for studies being uploaded into the NTRR and welcomes your input.

Following your review of the current Trauma Core CDEs and their overlap with FITBIR’s Core, please provide your feedback below by January 31, 2024. Thank you for engaging in this process to ensure the NTRR is maximally useful and effective.

https://www.nattrauma.org/coordinating-center/4138-2/