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The library below contains all common data elements and unique data elements. This includes published and approved data elements that have been created from FITBIR's data dictionary as well as the final version of the NINDS TBI Common Data Elements.
The library below contains all Published, Awaiting Publication, and Shared Draft form structures. Form structures in the Archived or Draft state require a FITBIR account.
NINDS CDE project defined a set of Core CDEs to collect an essential information applicable to any study.
Examples of the General Core CDEs and forms include basic demographic information and basic enrollment data collected from all study participants.
Examples of disease-specific Core CDEs for Traumatic Brain Injury studies include CDEs for the Glasgow Outcome Scale.
| variable name | title | element type | 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.LOINC | external ID.SNOMED | external ID.caDSR | external ID.CDISC | external ID.NINDS | population.all | 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.congenital 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.congenital muscular dystrophy | classification.spinal cord injury | classification.headache | classification.epilepsy | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 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 | |||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||
| GenderTyp | Sex type | Common Data Element | Self-reported sex of the participant/subject. Consistent with Executive Order 14168. | Self-reported sex of the participant/subject. | 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. | BRICS disclaimer: Consistent with Executive Order 14168. | What is the subject's sex | 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 | |||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||
| ImgBrainAssessmtReslt | Imaging brain assessment result | Common Data Element | Result of the global assessment of brain imaging | Result of the global assessment of brain imaging | Alphanumeric | Single Pre-Defined Value Selected | Abnormal;Normal;Not assessed;Unknown | Abnormal;Normal;Not assessed;Unknown | 10;20;555;999 | Choose one. | Brain imaging result (choose one) | Core_TBI | 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 | C02500 | Adult and Pediatric | Assessments and Examinations.Imaging Diagnostics | Assessments and Examinations.Imaging Diagnostics | Supplemental | Core | Core | Core | Core | Brain imaging result | NIH/CIT/BRICS | Olga Vovk | olga.vovk@nih.gov | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | |||||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||
| 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 | |||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||||
| 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 subject’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 | |||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||
| TBITyp | TBI type | Common Data Element | Broad classification of the type of traumatic brain injury experienced by participant/subject | Indicator of the type of traumatic brain injury experienced by participant/subject | Alphanumeric | Multiple Pre-Defined Values Selected | Blast;Closed;Crush;Penetrating;Unknown | Blast;Closed;Crush;Penetrating;Unknown | 1;2;3;4;999 | TBI: Choose all that apply. | Different pathophysiologic mechanisms occur in different types of injury. Pediatric-specific notes: Blast injuries (any form of TBI occurring in association with a blast explosion) are a negligible cause of pediatric TBI outside of combat theaters | Type of TBI | 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. | C05420 | Adult and Pediatric | Disease/Injury Related Events.History of Disease/Injury Event | Core | Core | Core | Core | TBI type | NIH/NINDS | NINDSCDE | NINDSCDE@EMMES.COM | NIH/NINDS | NINDSCDE | NINDSCDE@EMMES.COM |
| variable name | title | element type | 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 | population.all | 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.congenital 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.congenital muscular dystrophy | classification.spinal cord injury | classification.headache | classification.epilepsy | 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 | |||||
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | No references available | 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/NINDS | NINDSCDE | NINDSCDE@emmes.com | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | |||||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 subject's race (as defined by OMB)? | TRACK_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. | 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/NINDS | NINDSCDE | NINDSCDE@emmes.com | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | |||||||||||||||||||||||||
| RaceCat | Race category | Common Data Element | Category of race(s) or region(s) the participant/subject most closely identifies with | Category of race(s) or region(s) the participant/subject most closely identifies with | Alphanumeric | Multiple Pre-Defined Values Selected | Alaskan Native;Black African;Black African American;Black Afro Carribean;Far Eastern Asian;Hawaiian;Inuit;North American Indian;Not reported;Other;Pacific Islander;South Asian;South/Central American Indian;Unknown;Western Asian;White African;White Australian;White European;White Middle Eastern;White North American;White South American | Alaskan Native (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);Black African (for OMB purposes, this value is considered to be part of Black or African-American);Black African American (for OMB purposes, this value is considered to be part of Black or African-American);Black Afro Carribean (for OMB purposes, this value is considered to be part of Black or African-American);Far Eastern Asian (e.g., China, Japan, Korea, etc.) (for OMB purposes, this value is considered to be part of Asian);Hawaiian (for OMB purposes, this value is considered to be part of Native Hawaiian or Other Pacific Islander);Inuit (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);North American Indian (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);Not reported;Other;Pacific Islander (for OMB purposes, this value is considered to be part of Native Hawaiian or Other Pacific Islander);South Asian (Indian subcontinent) (for OMB purposes, this value is considered to be part of Asian);South/Central American Indian (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);Unknown;Western Asian (e.g., Pakistan, Iraq, Iran) (for OMB purposes, this value is considered to be part of Asian);White African (for OMB purposes, this value is considered to be part of White);White Australian (for OMB purposes, this value is considered to be part of White);White European (for OMB purposes, this value is considered to be part of White);White Middle Eastern (for OMB purposes, this value is considered to be part of White);White North American (for OMB purposes, this value is considered to be part of White);White South American (for OMB purposes, this value is considered to be part of White) | 1;2;3;4;5;6;7;8;9;444;11;12;13;999;15;16;17;18;19;20;21 | 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 subject's enrolled on an annual basis using the racial categories listed. | What is the subject's race (expanded categories)? | TRACK_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. | Adult and Pediatric | 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 | Supplemental | Core | Core | Race expanded category | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | ||||||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Injury_History;TRACK_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. | 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/NINDS | NINDSCDE | NINDSCDE@emmes.com | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | ||||||||||||||||||||||||||||||||||||||||||
| 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 also coded using SNOMED CT codes prior to aggregation or sharing. Refer to MedclHistCondSNOMEDCTCode Core CDE. | Medical history condition text | Medical_History | ALS/DMD/GENERAL/MG/NMD/SCI/SMA/STROKE/TBI: SNOMED CT Codes (https://www.nlm.nih.gov/healthit/snomedct/) | 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. C00322. | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | |||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||
| GenderTyp | Sex type | Common Data Element | Self-reported sex of the participant/subject. Consistent with Executive Order 14168. | Self-reported sex of the participant/subject. | 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. | BRICS disclaimer: Consistent with Executive Order 14168. | What is the subject's sex | 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 | |||||||||||||||
| 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. | 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 | Medical_History | SNOMED CT Codes (https://www.nlm.nih.gov/healthit/snomedct/) | 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. C00313. | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | |||||||||||||||||||||||
| 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 ethnic background? | TRACK_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. | 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/NINDS | NINDSCDE | NINDSCDE@emmes.com | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | |||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||
| 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? | 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 | 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 | 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 | Core | Core | Core | Core | Supplemental | Core | Core | Core | Core | Core | Core | Core | Birth date | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | |||||||||||||||||||||
| 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? | Demographics | National Health and Nutrition Examination Survey (http: //www.cdc.gov/nchs/nhanes.htm) | 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 | ||||||||||||||||||||||||||||||||||||||
| 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? | No references available | 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 | Sex participant or subject type | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | ||||||||||||||||||||||||||||||||||||||
| 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 | No references available | 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 | Supplemental | Supplemental | Supplemental | Supplemental | Supplemental | Supplemental | Supplemental | Supplemental | Supplemental | Core | Supplemental | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | |||||||||||||||||||||||||||||
| 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/NMD/SMA/EPILEPSY/MS/ STROKE: National Health and Nutrition Examination Survey (http://www.cdc.gov/nchs/nhanes.htm) 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 | EPILEPSY?FA/GENERAL/HEADASHE/MS/NMD/SMA/STROKE: National Health and Nutrition Examination Survey (http://www.cdc.gov/nchs/nhanes.htm) | 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 | Supplemental | Supplemental | Supplemental | Supplemental | Supplemental | Supplemental | Supplemental | Supplemental | Supplemental | Core | Supplemental | NIH/NINDS | NINDSCDE | NINDSCDE@emmes.com | NIH/CIT/BRICS | NINDSCDE | NINDSCDE@emmes.com | |||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||||||
| 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 |
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