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Form Structure: FITBIR Medical History Form

This form structure is an organized set of data definitions for a form that has not been copyrighted
Title:
FITBIR Medical History Form
Short Name:
MedHx_FITBIR
Description:
Medical history for FITBIR. Includes general medical history information, use of medications - concomitant and prior, history of illicit drugs used (if any), and history of TBI (if any). References: National Institute of Neurological Disorders and Stroke (NINDS) CDE project, Traumatic Brain Injury (TBI) CDEs (v2), https://www.commondataelements.ninds.nih.gov/TBI.aspx#tab=Data_Standards John K. Yue, Mary J. Vassar, Hester F. Lingsma, Shelly R. Cooper, David O. Okonkwo, Alex B. Valadka, Wayne A. Gordon, Andrew I. R. Maas, Pratik Mukherjee, Esther L. Yuh, Ava M. Puccio, David M. Schnyer, Geoffrey T. Manley and TRACK-TBI Investigators including:, Scott S. Casey, Maxwell Cheong, Kristen Dams-O'Connor, Allison J. Hricik, Emily E. Knight, Edwin S. Kulubya, David K. Menon, Diane J. Morabito, Jennifer L. Pacheco, and Tuhin K. Sinha. Journal of Neurotrauma. October 2013, 30(22): 1831-1844. doi:10.1089/neu.2013.2970.
Disease:
Traumatic Brain Injury
Organization:
FITBIR
Required Program Form:
Yes
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Publication Date:
2017-09-08
Version:
1.0
Date Created:
2015-11-29
Owner:
Number of Data Elements:
219
eForms:
N
Logically grouped data elements with defined frequency at which they repeat.

# Title Short Description Variable Name Required? Type
1 GUID   Global Unique ID which uniquely identifies a subject GUID Required CDE
2 Subject identifier number   An identification number assigned to the participant/subject within a given protocol or a study. SubjectIDNum Optional CDE
3 Age in years   Value for participant's subject age recorded in years. AgeYrs Recommended CDE
4 Vital status   Status of participant/subject as alive or dead VitStatus Optional CDE
5 Visit date   Actual interview or visit date VisitDate Recommended CDE
6 Site name   The name of the site for the study SiteName Recommended CDE
7 Days since baseline   The number of days since baseline DaysSinceBaseline Optional CDE
8 Case control indicator   Indicator of whether subject is in the case or control arm of the study. CaseContrlInd Optional CDE
9 General notes text   General notes GeneralNotesTxt Optional CDE

Additional Element Groups

Listed below are your additional element groups.

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Form Administration (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Language form administration ISO code  Code (ISO 639-2) for the language that was used for CRF/instrument/scale/etc. administration LangCRFAdministratISOCode Recommended CDE
2 Language form administration ISO code other text  The free-text field related to 'Language used for CRF/instrument/scale/etc. administration ISO code' specifying other text. LangCRFAdministratISOCodeOTH Recommended CDE
3 Context type  The context to which the questions were answered ContextType Recommended CDE
4 Context type other text  The free-text related to ContextType specifying other text ContextTypeOTH Recommended CDE
5 Data source  Source of the data provided on the case report form DataSource Recommended CDE
6 Data source other text  The free-text field related to Data source specifying other text. Source of the data provided on the case report form DataSourceOTH Recommended CDE

Birth History (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Born prematurely indicator  Indicator of whether the participant/subject was informed by a physician or parent/guardian that he/she was born prematurely BornPrematurInd Recommended CDE
2 Gestational age value  Time elapsed in weeks between the first day of the last normal menstrual period and the day of delivery of the participant/subject. GestatnlAgeVal Optional CDE
3 APGAR one minute score  Score of a newborn recorded at one minute from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsiveness. APGAR1MinScore Recommended CDE
4 APGAR five minute score  Score of a newborn recorded at five minutes from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsiveness. APGARFiveMinuteScore Recommended CDE
5 APGAR ten minute score  Score of a newborn recorded at ten minutes from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsiveness. APGARTenMinuteScore Recommended CDE
6 Birth weight value  Birth weight according to the participant's/subject's medical report or reported by the parent or legal guardian BirthWgtVal Recommended CDE
7 Perinatal neurologic event type  Type of perinatal neurologic injury (if any). PerinatlNeurolEventTyp Recommended CDE
8 Perinatal neurologic event other text  The free-text field related to 'Perinatal neurologic event type' specifying other text. Type of perinatal neurologic injury PerinatlNeurolEventOTH Recommended CDE
9 Neonatal problems indicator  Whether the participant/subject has a history of problems as an infant during the first month after birth NeonatProblemInd Recommended CDE
10 Neonatal problem other text  Specify in text the problems other than those listed that occurred during the neonatal period NeonatalProblemOtherText Recommended CDE
11 Neonatal intensive care unit stay indicator  Indicator whether the participant/subject had to stay in the neonatal intensive care unit (NICU) NICUStayInd Recommended CDE
12 Neonatal intensive care unit stay duration  Duration of the participant/subject's stay in the neonatal intensive care unit (NICU) NICUStayDur Recommended CDE
13 Postnatal age value  Time elapsed after birth of the participant/subject PostnatalAgeVal Optional CDE

Past Medical History Global Assessment (Appears Up To 23 Times)

# Title Short Description Variable Name Required? Type
1 Medical history for body system indicator  Indicator of whether the participant/subject has a history of medical problems/conditions for the specific body system. MedclHistBodySysInd Recommended CDE
2 Body system category  Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. BodySysCat Recommended CDE
3 Body system category other text  Free-text related to "Body System category" CDE used in the comprehensive assessment of a participant/subject.. BodySysOTH Recommended CDE
4 Medical history taken date and time  Date (and time, if applicable and known) the participant/subject's medical history was taken MedclHistTakenDateTime Recommended CDE
5 Medical history condition start date and time  Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history MedclHistCondStrtDateTime Recommended CDE
6 Medical history condition end date and time  Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history MedclHistCondEndDateTime Recommended CDE
7 Medical history condition SNOMED CT code  Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject MedclHistCondSNOMEDCTCode Recommended CDE
8 Medical history condition text  Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history MedclHistCondTxt Recommended CDE

Ongoing Medical History Global Assessment (Appears Up To 23 Times)

# Title Short Description Variable Name Required? Type
1 Medical history for body system indicator  Indicator of whether the participant/subject has a history of medical problems/conditions for the specific body system. MedclHistBodySysInd Recommended CDE
2 Body system category  Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. BodySysCat Recommended CDE
3 Body system category other text  Free-text related to "Body System category" CDE used in the comprehensive assessment of a participant/subject.. BodySysOTH Recommended CDE
4 Medical history taken date and time  Date (and time, if applicable and known) the participant/subject's medical history was taken MedclHistTakenDateTime Recommended CDE
5 Medical history condition start date and time  Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history MedclHistCondStrtDateTime Recommended CDE
6 Medical history condition end date and time  Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history MedclHistCondEndDateTime Recommended CDE
7 Medical history condition SNOMED CT code  Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject MedclHistCondSNOMEDCTCode Recommended CDE
8 Medical history condition text  Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history MedclHistCondTxt Recommended CDE

Hospitalizations (Appears Up To 2 Times)

# Title Short Description Variable Name Required? Type
1 Hospitalizations indicator  Have you ever been hospitalized? HospitalizationsInd Recommended CDE
2 Hospitalization non-surgical elective indicator  Indicator of whether the enumerated non-surgical hospitalization was elective HosptlizatnNonSurgElectvInd Optional CDE
3 Alcohol use related to hospitalization indicator  Indicator of whether the participant/subject has been hospitalized for an alcohol-related problem (i.e., esophageal varices, delirium tremens (DTs), cirrhosis and others) AlcUseRelatedHospInd Optional CDE
4 Hospitalization reason  Reason why the participant/subject was hospitalized, excluding all surgeries HospitRsn Optional CDE
5 Hospitalization past year count  Count of all hospitalizations the participant had within the past year for any reason HospitPastYrCt Optional CDE
6 Hospitalization other text  The free-text field related to 'Hospitalization reason' specifying other text. Reason why the participant/subject was hospitalized, excluding all surgeries HospitOTH Optional CDE
7 Hospitalization non surgical number  Number used to identify the non-surgical hospitalization being described HosptlizatnNonSurgNum Optional CDE
8 Surgical or therapeutic procedure performed indicator  Indicator whether the participant/subject has undergone a surgical or other therapeutic procedure SurgTherProcedurPerfInd Optional CDE

History of TBIs (Appears Up To 4 Times)

# Title Short Description Variable Name Required? Type
1 Prior traumatic injury indicator  Indicator of prior traumatic injury found either historically, previous emergency department visits, radiographic findings, or signs or symptoms at time of presentation. PriorTraumInjryInd Recommended CDE
2 Prior traumatic injury type  General location of traumatic injury, if evidence of prior traumatic injury PriorTraumInjryType Recommended CDE
3 Medical history condition text  Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history MedclHistCondTxt Optional CDE
4 Concussion prior number  Number of prior concussions ConcussionPriorNum Recommended CDE
5 Head injury prior number  Number of prior head injuries, if previous TBI history HeadInjPriorNum Recommended CDE

Headaches Migraines History (Appears Up To 15 Times)

# Title Short Description Variable Name Required? Type
1 Context type  The context to which the questions were answered ContextType Recommended CDE
2 Context type other text  The free-text related to ContextType specifying other text ContextTypeOTH Recommended CDE
3 Headache history indicator  Indicates whether participant/subject suffers from headaches HeadachHistInd Recommended CDE
4 Headache migraine diagnosis indicator  Indicator of whether the participant/subject has been diagnosed with the type of headache or migraine HeadachMigranDiagnsInd Recommended CDE
5 Headache migraine type  Type of headache or migraine HeadachMigranTyp Recommended CDE
6 Additional comment text  Text describing any additional information about the participant or the participant's family history AddtnalCommntTxt Optional CDE
7 Headache affect activity level indicator  Indicates whether the headache changes activity level (i.e., stop playing) HeadachAffctActvtyLvlInd Optional CDE
8 Headache average days per month count  Actual number of headache days per month the participant/subject had in the past 3 months HeadachAveDayMonthCt Optional CDE
9 Headache frequency  Frequency with which headache occurs HeadachFreq Optional CDE
10 Headache typical severity type  The participant's/subject's typical headache pain severity HeadachTypclSevertyTyp Optional CDE
11 Headache frequency change indicator  Indicator of whether 3 month headache frequency represents a change compared to the prior 3 months HeadachFreqChngInd Optional CDE
12 Headache frequency change type  Frequency change description HeadachFreqChngTyp Optional CDE
13 Headache typical associate symptom type  Type of symptoms the participant/subject experiences when he/she has a headache HeadachTypclAssctSymptmTyp Optional CDE
14 Headache typical level activities affected result  Result of onset of headache in usually daily activities HeadachTypclLvlActvtyAffctRslt Optional CDE
15 Headache typical pain intensity rating scale  Rating scale for the pain of this headache on a scale of 0 -10 HeadacheTypPainIntstyRateScale Optional CDE

Study Medications (Appears Up To 32 Times)

# Title Short Description Variable Name Required? Type
1 Medication supplement use indicator  Indicator of whether the participant/subject has ever taken physician prescribed medications, investigational medications or supplements MedctnSupplUseInd Recommended CDE
2 Medication study ongoing use indicator  Indicator of or description that the study medication usage is ongoing. MedicationStudyOngoingInd Recommended CDE
3 Medication study name  Name of the study medication or drug administered. MedicationStudyName Recommended CDE
4 Study drug start date and time  Date (and time, if applicable and known) on which the study drug usage begins StdyDrugStrtDateTime Recommended CDE
5 Study drug end date and time  Date (and time, if applicable and known) the administration of the study drug ended StdyDrugEndDateTime Recommended CDE
6 Medication study reason for administration text  Text describing reason for administration of a study agent or measure. This is not the pharmacologic classification of an agent (antibiotic, analgesic, etc.), but the reason for its administration to the participant/subject. MedicationStudyReasonTxt Recommended CDE
7 Study drug dose  Dose of study drug taken per administration StdyDrugDose Recommended CDE
8 Study drug dose unit of measure  Unit of measure of the study drug dosage administered StdyDrugDoseUoM Recommended CDE
9 Study drug dose unit of measure UCUM code  Code that represents the dosage unit of measure of the study drug administered StdyDrugDoseUoMUCUMCd Recommended CDE
10 Study drug dose frequency  Frequency of use of study drug StdyDrugDoseFreq Recommended CDE
11 Medication study route type  Type of access route for the administration of the study medication. MedicationStudyRteTyp Optional CDE
12 Medication study route other text  The free-text field related to 'Medication study route type' specifying other text. Type of access route for the administration of the study medication. MedicationStudyRteTypOTH Optional CDE
13 Medication study description response text  Description of the response to the study medication. MedicationStudyResponseTxt Optional CDE
14 Study drug dosage form text  Text of dosage form used to administer study drug StdyDrugDosageFormTxt Recommended CDE
15 Medication study PRN average monthly frequency  Average frequency per month for any study medications. MedicationStudyPRNAMonthFreq Optional CDE
16 Medication study RXNorm code  Code for name of the study medication or agent (drug) administered. MedicationStudyRxNormCode Optional CDE
17 Medication study discontinuation reason  Reason the participant/subject discontinued taking the study medication. MedicationStudyDiscontRsnTxt Optional CDE

Medications Concomitant (Appears Up To 32 Times)

# Title Short Description Variable Name Required? Type
1 Medication supplement use indicator  Indicator of whether the participant/subject has ever taken physician prescribed medications, investigational medications or supplements MedctnSupplUseInd Recommended CDE
2 Medication supplement name  Name of the medication or supplement administered MedctnSupplName Recommended CDE
3 Medication prior or concomitant use indicator  Indicator of whether the participant/subject reported taking any medications during the time period relevant to the study protocol MedctnPriorConcomUseInd Recommended CDE
4 Medication prior or concomitant name  Name of the prior/concomitant agent or drug administered. MedctnPriorConcomName Recommended CDE
5 Medication prior or concomitant RXNorm code  Code for name of the prior/concomitant agent or drug administered. MedctnPriorConcomRxNormCode Optional CDE
6 Medication prior or concomitant indication text  Text describing reason for administration of a prior/concomitant (no study) agent or measure. This is not the pharmacologic classification of an agent (antibiotic, analgesic, etc.), but the reason for its administration to the participant/subject. MedctnPriorConcomIndTxt Optional CDE
7 Medication prior or concomitant ongoing indicator  Indicator of or description that the prior/concomitant medication usage is ongoing. MedctPrConcomOngoingInd Recommended CDE
8 Medication prior or concomitant start date and time  The date (and time, if applicable and known) on which the prior/concomitant medication usage began. MedctnPriorConcomStrtDateTime Optional CDE
9 Medication prior or concomitant end date and time  The date (and time, if applicable and known) the administration of the prior/concomitant medication ended. MedctnPriorConcomEndDateTime Optional CDE
10 Medication prior or concomitant dose  Dose of prior/concomitant medication taken per administration. MedctnPriorConcomDose Optional CDE
11 Medication prior or concomitant dose unit of measure  Dosage unit of measure of the prior or concomitant medication administered. MedctnPriorConcomDoseUo Optional CDE
12 Medication prior or concomitant dose unit of measure other text  The free-text field related to 'Medication prior or concomitant dose unit of measure' specifying other text. Dosage unit of measure of the prior or concomitant medication administered. MedctnPriorConcomDoseUoMOTH Optional CDE
13 Medication prior or concomitant dose unit of measure UCUM code  Code that represents the dosage unit of measure of the prior or concomitant medication administered. Unified Code for Units of Measure (UCUM). MedctnPriorConcomDoseUoMUCUMCd Optional CDE
14 Medication prior or concomitant dose frequency  Frequency of use of a prior/concomitant medication. MedctnPriorConcmtntDoseFreq Optional CDE
15 Medication prior or concomitant dose frequency other text  Frequency of use of a prior/concomitant medication other text MedctnPriorConcmtntDoseFreqOTH Optional CDE
16 Medication prior or concomitant route type  Type of access route for the administration of the prior/concomitant medication. MedctnPriorConcomRteTy Optional CDE
17 Medication prior or concomitant route other text  The free-text field related to 'Medication prior or concomitant route type' specifying other text. Type of access route for the administration of the prior/concomitant medication. MedctnPriorConcomRteOTH Optional CDE
18 Adverse event track number  The adverse tracking number that is associated with a particular medication listed. AdverseEventTrackNum Optional CDE

Medications Prior (Appears Up To 32 Times)

# Title Short Description Variable Name Required? Type
1 Medication supplement name  Name of the medication or supplement administered MedctnSupplName Recommended CDE
2 Medication supplement use indicator  Indicator of whether the participant/subject has ever taken physician prescribed medications, investigational medications or supplements MedctnSupplUseInd Recommended CDE
3 Medication prior or concomitant use indicator  Indicator of whether the participant/subject reported taking any medications during the time period relevant to the study protocol MedctnPriorConcomUseInd Recommended CDE
4 Medication prior or concomitant name  Name of the prior/concomitant agent or drug administered. MedctnPriorConcomName Recommended CDE
5 Medication prior or concomitant RXNorm code  Code for name of the prior/concomitant agent or drug administered. MedctnPriorConcomRxNormCode Optional CDE
6 Medication prior or concomitant indication text  Text describing reason for administration of a prior/concomitant (no study) agent or measure. This is not the pharmacologic classification of an agent (antibiotic, analgesic, etc.), but the reason for its administration to the participant/subject. MedctnPriorConcomIndTxt Optional CDE
7 Medication prior or concomitant ongoing indicator  Indicator of or description that the prior/concomitant medication usage is ongoing. MedctPrConcomOngoingInd Optional CDE
8 Medication prior or concomitant start date and time  The date (and time, if applicable and known) on which the prior/concomitant medication usage began. MedctnPriorConcomStrtDateTime Optional CDE
9 Medication prior or concomitant end date and time  The date (and time, if applicable and known) the administration of the prior/concomitant medication ended. MedctnPriorConcomEndDateTime Optional CDE
10 Medication prior or concomitant dose  Dose of prior/concomitant medication taken per administration. MedctnPriorConcomDose Optional CDE
11 Medication prior or concomitant dose unit of measure  Dosage unit of measure of the prior or concomitant medication administered. MedctnPriorConcomDoseUo Optional CDE
12 Medication prior or concomitant dose unit of measure other text  The free-text field related to 'Medication prior or concomitant dose unit of measure' specifying other text. Dosage unit of measure of the prior or concomitant medication administered. MedctnPriorConcomDoseUoMOTH Optional CDE
13 Medication prior or concomitant dose unit of measure UCUM code  Code that represents the dosage unit of measure of the prior or concomitant medication administered. Unified Code for Units of Measure (UCUM). MedctnPriorConcomDoseUoMUCUMCd Optional CDE
14 Medication prior or concomitant dose frequency  Frequency of use of a prior/concomitant medication. MedctnPriorConcmtntDoseFreq Optional CDE
15 Medication prior or concomitant dose frequency other text  Frequency of use of a prior/concomitant medication other text MedctnPriorConcmtntDoseFreqOTH Optional CDE
16 Medication prior or concomitant route type  Type of access route for the administration of the prior/concomitant medication. MedctnPriorConcomRteTy Optional CDE
17 Medication prior or concomitant route other text  The free-text field related to 'Medication prior or concomitant route type' specifying other text. Type of access route for the administration of the prior/concomitant medication. MedctnPriorConcomRteOTH Optional CDE
18 Adverse event track number  The adverse tracking number that is associated with a particular medication listed. AdverseEventTrackNum Optional CDE

Allergies (Appears Up To 30 Times)

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

Behavioral History (Appears Up To 15 Times)

# Title Short Description Variable Name Required? Type
1 Context type  The context to which the questions were answered ContextType Recommended CDE
2 Context type other text  The free-text related to ContextType specifying other text ContextTypeOTH Recommended CDE
3 Alcohol current use indicator  Indicator of whether the participant/subject consumed at least one alcoholic drink within the past 12 months AlcCurntUseInd Recommended CDE
4 Alcohol prior use indicator  Indicator of the participant's/subject's alcohol consumption prior to the past 12 months AlcPriorUseInd Recommended CDE
5 Alcohol use duration  Duration in years participant/subject has used alcohol (ingesting of alcoholic beverages, including social drinking) AlcoholUseDuratn Optional CDE
6 Alcohol use last month days drank number  During the past 30 days, how many days per month did you have at least one drink of any alcoholic beverage such as beer, wine, a malt beverage or liquor? AlcoholUseLastMoDayDrnkNum Optional CDE
7 Alcohol use last month drinking day average drinks number  During the past 30 days, on the days when you drank, about how many drinks did you drink on the average? NOTE: One drink is equivalent to a 12-ounce beer, a 5-ounce glass of wine, or a drink with one shot of liquor. AlchlUseLstMoDrnkDyAvgDrnksNum Optional CDE
8 Alcohol use last month consumed more than four or five drinks days number  Considering all types of alcoholic beverages, how many times during the past 30 days did you have X [X = 5 for men, X = 4 for women] or more drinks on an occasion? AlcohlLstMoConsmOvr5DrnkDayNum Optional CDE
9 Alcohol use started age value  Age in years when participant/subject started ingesting alcoholic beverages, including social drinking AlcUseStrtAgeVal Optional CDE
10 Alcohol use stopped age value  Age in years when participant/subject stopped ingesting alcoholic beverages, including social drinking AlcUseStopAgeVal Optional CDE
11 Drug or substance prior illicit use indicator  Indicator of participant's/subjects use of illegal drugs, prescription or over-the-counter drugs prior to the past 12 months for purposes other than those for which they are meant to be used, or in large amounts DrugSubstncPriorIllictUseInd Recommended CDE
12 Drug or substance current illicit use indicator  Indicator of participant's/subject's use of illegal drugs, prescription or over-the-counter drugs in the past year for purposes other than those for which they are meant to be used, or in large amounts DrgSubstCurrntIllicitUseCat Recommended CDE
13 Drug or substance illicit use duration  Duration, in years, the participant/subject has used an unprescribed, controlled psychoactive drugs or substances used by the participant/subject. DrgSubsIllctUseDur Optional CDE
14 Drug or substance illicitly used category  Category of illegal drugs, prescription, or over-the-counter drugs the participant/subject used for purposes other than those for which they are meant to be used, or in large amounts DrgSubIllctUseCat Optional CDE
15 Tobacco current use indicator  Indicator for whether the participant/subject regularly uses tobacco products (e.g. cigarettes, cigars, chewing tobacco or pipe) at the present time. TobcoUseCurntInd Recommended CDE
16 Tobacco prior use indicator  Indicator of the participant's/subject's past regular tobacco (e.g. cigarettes, cigars, chewing tobacco or pipe) use prior to the past 12 months TobcoPriorUseInd Recommended CDE
17 Tobacco use duration  Duration in years participant/subject has used tobacco products (e.g. cigarettes, cigars, chewing tobacco or pipe) TobcoUseDur Optional CDE
18 Tobacco product used type  Type of tobacco product (e.g. cigarettes, cigars, chewing tobacco or pipe) used by the participant/subject TobcoProdctUsedTyp Optional CDE
19 Tobacco product used other text  The free-text field related to 'Tobacco product used type' specifying other text. Type of tobacco product (e.g. cigarettes, cigars, chewing tobacco or pipe) used by the participant/subject TobcoProdctUsedOTH Recommended CDE

Drug Screen Test (Appears Up To 50 Times)

# Title Short Description Variable Name Required? Type
1 Drug screen indicator  Indicator of whether a drug screen was performed DrugScreenInd Recommended CDE
2 Drug screen qualitative result  Overall result of toxic drug screen DrgScrnQualReslt Optional CDE
3 Drug screen sample type  Type of sample used to perform the toxic drug screen DrgScrnSamplTyp Optional CDE
4 Drug screen sample other text  The free-text field related to 'Drug screen sample type' specifying other text. Type of sample used to perform the toxic drug screen DrgScrnSamplOTH Optional CDE
5 Drug screen positive substance type  Type of substance(s) found positive in overall toxic drug screen DrgScrnPosSubstncTyp Optional CDE
6 Drug screen positive substance other text  The free-text field related to 'Drug screen positive substance type' specifying other text. Type of substance(s) found positive in overall toxic drug screen DrgScrnPosSubstncOTH Optional CDE

Reasonable Accommodations (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Reasonable accommodations requirement indicator  Indicator for reasonable accommodations requirement ReasonAccommodRequiredInd Optional CDE
2 Reasonable accommodations type  Type of reasonable accommodations ReasonAccommodTyp Optional CDE
3 Reasonable accommodations type other text  The free-text related to 'Reasonable accommodations type' specifying other text ReasonAccommodTypOTH Optional CDE
4 Reasonable accommodations accessibility type  Type of reasonable accommodations accessibility ReasonAccommodAccessTyp Optional CDE
5 Reasonable accommodations accessibility type other text  The free-text related to 'Reasonable accommodations accessibility type' specifying other text ReasonAccommodAccessTypOTH Optional CDE

Past Medical History Codes (Appears Up To 1 Time)

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

Ongoing Medical History Codes (Appears Up To 1 Time)

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

Change History