This form structure is an organized set of data definitions for a form that has not been copyrighted

 General Details

Title:
FITBIR Laboratory Test Form
Short Name:
LabTestExtended_FITBIR
Description:
FITBIR form for laboratory tests. References:4. National Institute of Neurological Disorders and Stroke (NINDS) CDE project, TBICDEs, Laboratory Tests form(F0320_Laboratory_Tests) https://www.commondataelements.ninds.nih.gov/TBI.aspx#tab=Data_Standards
Disease:
Traumatic Brain Injury
Organization:
FITBIR
Required Program Form:
No
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Version:
1.0
Date Created:
2016-03-25
Owner:
Number of Data Elements:
155
eForms:
N

 Documentation


 Groups & Attached Data Elements

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.

Form Administation (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
7 Assessment completion status  Status of completion of an assessment, such as a case report from (CRF), instrument, scale, computer assessment, etc. AssessmentCompletionStat Recommended CDE
8 Assessment completion status text  A free text related to "Assessment completion status" specifying completion details. This data element should be used along with AssessmenttCompletionStat to further describe the status of assessment completion AssessmentCompletionStatTxt Optional CDE
9 BRICS data completeness index  Index reflecting the completeness of data in BRICS calculated for a given row as % of missing variables. Calculated in % BRICSDataCompletIndex Optional CDE
10 Data captured by type  Type of an individual (or a device) who captured the subject data and/or filled out the case report form (CRF), questionnaire, assessment form, computerized test, etc., including eFORMs and automatic sensors DataCapturedByTyp Recommended CDE
11 Data captured by other text  The free-text field related to "Data captured by whom type" specifying other text DataCapturedByTypOTH Optional CDE

Laboratory Tests (Repeat Infinitely)

# Title Short Description Variable Name Required? Type
1 Lab test performed indicator  Indicator of whether the lab test has been performed on the participant/subject LabTestPerfInd Optional CDE
2 Lab test LOINC code  Identifier name given to a test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. LabTestLOINCCode Recommended CDE
3 Lab test date and time  Date or Date and Time,if available and known, when the lab test was performed. LabTestDateTime Recommended CDE
4 Lab test date and time record type  Whether the lab test date and time is accurately recorded or estimated LabTestDateTimeRecTyp Recommended CDE
5 Lab test date and time record is unknown or estimated reason  Reason why of whether the lab test date and time is unknown or estimated. LabTestDateTimeUnknownRsn Optional CDE
6 Lab specimen collection date and time  Date (and time if applicable and known) when the specimen was collected LabSpecmnCollDateTime Recommended CDE
7 Lab specimen type  Type of specimen collected for the laboratory test LabSpecmnTyp Recommended CDE
8 Lab specimen other text  The free-text field related to 'Lab specimen type' specifying other text. Type of specimen collected for the laboratory test LabSpecmnOTH Optional CDE
9 Lab test name  Name representing the lab test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. LabTestName Recommended CDE
10 Lab test other text  Free-text for 'Lab test name'. Name representing the lab test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. LabTestOTH Optional CDE
11 Lab test result value  Result of the laboratory test LabTestResltVal Optional CDE
12 Lab test result unit of measure  Unit of measure for the laboratory test result LabTestResltUoM Optional CDE
13 Lab test result unit of measure UCUM code  Unified Code for Units of Measure (UCUM) unit code for the result of the lab test being performed on the specimen LabTestResltUoMUCUMCode Optional CDE
14 Laboratory test medication indicator  Indicator of medication present during lab test LabTestMedctnInd Recommended CDE
15 Laboratory test medication name  Name of medication(s) present during lab test LabTestMedctnName Optional CDE
16 Laboratory test lowest range value  Lowest possible value in the range of the lab test LabTestLowRangeVal Optional UDE
17 Laboratory test highest range value  Highest possible value in the range of the lab test LabTestHighRangeVal Optional UDE
18 Lab test result status  Status of the laboratory test result, usually based upon the comparison of the test result to the normal range for the lab test performed LabTestResltStatus Recommended CDE
19 Lab test abnormality significance type  Indicator as to whether or not the abnormal lab result for the associated test was considered clinically significant for the participant/subject. LabTestAbnrmlySignfcnceTyp Optional CDE
20 Lab test antibody result  Result of the antibody laboratory test LabTestAntibodyReslt Optional CDE
21 Fasting prior to sample collection indicator  Indicator whether participant/subject was fasting prior to collection of the sample on which the lab test being reported was performed FastBeforeLabTestInd Optional CDE
22 Data acquisition location type  Type of location where subject data were taken DataAcquisitionLocationTyp Optional CDE
23 Data acquisition location type other text  The free-text field related to Data acquisition location type, specifying other text. Type of location where the subject data were taken DataAcquisitionLocationOTH Optional CDE
24 Lab test comment  Comments on the laboratory test LabTestComment Optional UDE
25 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
26 Medication prior or concomitant name  Name of the prior/concomitant agent or drug administered. MedctnPriorConcomName Recommended CDE
27 Medication prior or concomitant ongoing indicator  Indicator of or description that the prior/concomitant medication usage is ongoing. MedctPrConcomOngoingInd Recommended CDE

Bloody Typing (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Lab test performed indicator  Indicator of whether the lab test has been performed on the participant/subject LabTestPerfInd Recommended CDE
2 Lab test LOINC code  Identifier name given to a test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. LabTestLOINCCode Recommended CDE
3 Lab test date and time  Date or Date and Time,if available and known, when the lab test was performed. LabTestDateTime Recommended CDE
4 Lab test date and time record type  Whether the lab test date and time is accurately recorded or estimated LabTestDateTimeRecTyp Recommended CDE
5 Lab test date and time record is unknown or estimated reason  Reason why of whether the lab test date and time is unknown or estimated. LabTestDateTimeUnknownRsn Optional CDE
6 Lab specimen collection date and time  Date (and time if applicable and known) when the specimen was collected LabSpecmnCollDateTime Recommended CDE
7 Lab specimen type  Type of specimen collected for the laboratory test LabSpecmnTyp Recommended CDE
8 Lab specimen other text  The free-text field related to 'Lab specimen type' specifying other text. Type of specimen collected for the laboratory test LabSpecmnOTH Optional CDE
9 Blood type  The blood type BloodTyp Recommended CDE
10 RhD factor type  The RhD factor type RhDFactorTyp Recommended CDE
11 Data acquisition location type  Type of location where subject data were taken DataAcquisitionLocationTyp Optional CDE
12 Data acquisition location type other text  The free-text field related to Data acquisition location type, specifying other text. Type of location where the subject data were taken DataAcquisitionLocationOTH Optional CDE
13 Lab test comment  Comments on the laboratory test LabTestComment Optional UDE

Pregnancy Test (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Pregnancy test performed indicator  Indicator as to whether or not a pregnancy test was performed on the participant/subject PregTestPerfInd Recommended CDE
2 Pregnancy test not applicable reason  Reason that performance of a pregnancy test was not applicable to the participant/subject PregTestNotApplcblRsn Optional CDE
3 Lab test LOINC code  Identifier name given to a test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. LabTestLOINCCode Recommended CDE
4 Pregnancy test date and time  The date (and time if applicable and known) when the pregnancy test was performed PregTestDateTime Recommended CDE
5 Lab test date and time record type  Whether the lab test date and time is accurately recorded or estimated LabTestDateTimeRecTyp Recommended CDE
6 Lab test date and time record is unknown or estimated reason  Reason why of whether the lab test date and time is unknown or estimated. LabTestDateTimeUnknownRsn Optional CDE
7 Lab specimen collection date and time  Date (and time if applicable and known) when the specimen was collected LabSpecmnCollDateTime Recommended CDE
8 Pregnancy test specimen type  Type of specimen collected to perform the pregnancy test PregTestSpecmnTyp Recommended CDE
9 Pregnancy test qualitative result value  Result of the pregnancy test PregTestQualResltVal Recommended CDE
10 Data acquisition location type  Type of location where subject data were taken DataAcquisitionLocationTyp Optional CDE
11 Data acquisition location type other text  The free-text field related to Data acquisition location type, specifying other text. Type of location where the subject data were taken DataAcquisitionLocationOTH Optional CDE
12 Lab test comment  Comments on the laboratory test LabTestComment Optional UDE

HIV test (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Lab test performed indicator  Indicator of whether the lab test has been performed on the participant/subject LabTestPerfInd Recommended CDE
2 Lab test LOINC code  Identifier name given to a test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. LabTestLOINCCode Recommended CDE
3 Lab test date and time  Date or Date and Time,if available and known, when the lab test was performed. LabTestDateTime Recommended CDE
4 Lab test date and time record type  Whether the lab test date and time is accurately recorded or estimated LabTestDateTimeRecTyp Recommended CDE
5 Lab test date and time record is unknown or estimated reason  Reason why of whether the lab test date and time is unknown or estimated. LabTestDateTimeUnknownRsn Optional CDE
6 Lab specimen collection date and time  Date (and time if applicable and known) when the specimen was collected LabSpecmnCollDateTime Recommended CDE
7 Lab specimen type  Type of specimen collected for the laboratory test LabSpecmnTyp Recommended CDE
8 Lab specimen other text  The free-text field related to 'Lab specimen type' specifying other text. Type of specimen collected for the laboratory test LabSpecmnOTH Optional CDE
9 HIV Test Qualitative Result Value  The value of the qualitative result for a performed HIV test. HIVTestResultVal Recommended CDE
10 Data acquisition location type  Type of location where subject data were taken DataAcquisitionLocationTyp Optional CDE
11 Data acquisition location type other text  The free-text field related to Data acquisition location type, specifying other text. Type of location where the subject data were taken DataAcquisitionLocationOTH Optional CDE
12 Lab test comment  Comments on the laboratory test LabTestComment Optional UDE

Hepatitis test (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Lab test performed indicator  Indicator of whether the lab test has been performed on the participant/subject LabTestPerfInd Recommended CDE
2 Lab test LOINC code  Identifier name given to a test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. LabTestLOINCCode Recommended CDE
3 Lab test date and time  Date or Date and Time,if available and known, when the lab test was performed. LabTestDateTime Recommended CDE
4 Lab test date and time record type  Whether the lab test date and time is accurately recorded or estimated LabTestDateTimeRecTyp Recommended CDE
5 Lab test date and time record is unknown or estimated reason  Reason why of whether the lab test date and time is unknown or estimated. LabTestDateTimeUnknownRsn Optional CDE
6 Lab specimen collection date and time  Date (and time if applicable and known) when the specimen was collected LabSpecmnCollDateTime Recommended CDE
7 Lab specimen type  Type of specimen collected for the laboratory test LabSpecmnTyp Recommended CDE
8 Lab specimen other text  The free-text field related to 'Lab specimen type' specifying other text. Type of specimen collected for the laboratory test LabSpecmnOTH Optional CDE
9 Hepatitis lab test name  Name representing the hepatitis lab test(s) performed on body fluid(s). HepatitisLabTestName Recommended CDE
10 Hepatitis lab test qualitative result value  The value of the qualitative result for a performed hepatitis lab test HepatitisLabTestResultVal Recommended CDE
11 Data acquisition location type  Type of location where subject data were taken DataAcquisitionLocationTyp Optional CDE
12 Data acquisition location type other text  The free-text field related to Data acquisition location type, specifying other text. Type of location where the subject data were taken DataAcquisitionLocationOTH Optional CDE
13 Lab test comment  Comments on the laboratory test LabTestComment Optional UDE

UTI test (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Lab test performed indicator  Indicator of whether the lab test has been performed on the participant/subject LabTestPerfInd Recommended CDE
2 Lab test LOINC code  Identifier name given to a test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. LabTestLOINCCode Recommended CDE
3 Lab test date and time  Date or Date and Time,if available and known, when the lab test was performed. LabTestDateTime Recommended CDE
4 Lab test date and time record type  Whether the lab test date and time is accurately recorded or estimated LabTestDateTimeRecTyp Recommended CDE
5 Lab test date and time record is unknown or estimated reason  Reason why of whether the lab test date and time is unknown or estimated. LabTestDateTimeUnknownRsn Optional CDE
6 Lab specimen collection date and time  Date (and time if applicable and known) when the specimen was collected LabSpecmnCollDateTime Recommended CDE
7 Lab specimen type  Type of specimen collected for the laboratory test LabSpecmnTyp Recommended CDE
8 Lab specimen other text  The free-text field related to 'Lab specimen type' specifying other text. Type of specimen collected for the laboratory test LabSpecmnOTH Optional CDE
9 Urinary tract infection symptom duration  Duration of symptoms associated with a bacterial infectious process affecting any part of the urinary tract, most commonly the bladder and the urethra. UTISymptmDur Recommended CDE
10 Urinary tract infection symptom type  Type of sign(s)/symptom(s) associated with a bacterial infectious process affecting any part of the urinary tract, most commonly the bladder and the urethra. UTISymptmTyp Recommended CDE
11 Urinary tract infection symptom other text  Text field to specify a symptom (other than those pre-defined) associated with a bacterial infectious process affecting any part of the urinary tract, most commonly the bladder and the urethra. UTISymptmOthrTxt Optional CDE
12 Urinary culture species text  Text to name a bacteria species in urine culture sample UrCultSpecTxt Recommended CDE
13 Urinary culture status  Status of urine culture result UrCultStatus Recommended CDE
14 Urine dipstick test leukocyte esterase status  Status of leukocyte esterase presence in urine dipstick test which indicates the presence of white blood cells in a urine sample. UrDipstckTstLeukEstrseStatus Recommended CDE
15 Urine dipstick test nitrite status  Status of nitrite presence in urine dipstick test UrDipstckTstNitrStatus Recommended CDE
16 Urinary culture sequence number  Number for the sequence of a particular bacteria species for drug-resistant test UrCultSeqNum Recommended CDE
17 Urinary culture resistance pattern type  Type of resistance pattern of a particular bacteria species in the urine culture sample UrCultResistPattrnTyp Recommended CDE
18 Urinary culture colony form unity measurement value  Value of colony forming associated with a bacterial species measured in Colony Forming Units (CFU)/mL UrCultCFUMeasrVal Recommended CDE
19 Data acquisition location type  Type of location where subject data were taken DataAcquisitionLocationTyp Optional CDE
20 Data acquisition location type other text  The free-text field related to Data acquisition location type, specifying other text. Type of location where the subject data were taken DataAcquisitionLocationOTH Optional CDE
21 Lab test comment  Comments on the laboratory test LabTestComment Optional UDE

Bacterial Culture(s) Test (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Lab test performed indicator  Indicator of whether the lab test has been performed on the participant/subject LabTestPerfInd Recommended CDE
2 Lab test LOINC code  Identifier name given to a test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. LabTestLOINCCode Recommended CDE
3 Lab test date and time  Date or Date and Time,if available and known, when the lab test was performed. LabTestDateTime Recommended CDE
4 Lab test date and time record type  Whether the lab test date and time is accurately recorded or estimated LabTestDateTimeRecTyp Recommended CDE
5 Lab test date and time record is unknown or estimated reason  Reason why of whether the lab test date and time is unknown or estimated. LabTestDateTimeUnknownRsn Optional CDE
6 Injury elapsed time  The elapsed time (in minutes) from the time of injury InjElapsedTime Recommended CDE
7 Lab specimen collection date and time  Date (and time if applicable and known) when the specimen was collected LabSpecmnCollDateTime Recommended CDE
8 Lab specimen type  Type of specimen collected for the laboratory test LabSpecmnTyp Recommended CDE
9 Lab specimen other text  The free-text field related to 'Lab specimen type' specifying other text. Type of specimen collected for the laboratory test LabSpecmnOTH Optional CDE
10 Bacterial culture species name  Name of a bacterial species in urine culture sample BacterialCulSpecName Recommended CDE
11 Bacterial culture species growth indicator  Indicator of whether the bacterial culture species on which lab test was performed grow BacterialCulSpecGrowthInd Recommended CDE
12 Bacterial culture result status  Status of bacterial culture result BacterialCulResultStatus Recommended CDE
13 Bacterial culture colony form unity measurement value  Value of colony forming associated with a bacterial species measured in Colony Forming Units (CFU)/mL BacterialCulSpecCFUMeasrVal Recommended CDE
14 Bacterial culture sequence number  Number for the sequence of a particular bacteria species for drug-resistant test BacterialCulSpecSeqNum Recommended CDE
15 Data acquisition location type  Type of location where subject data were taken DataAcquisitionLocationTyp Optional CDE
16 Data acquisition location type other text  The free-text field related to Data acquisition location type, specifying other text. Type of location where the subject data were taken DataAcquisitionLocationOTH Optional CDE
17 Lab test comment  Comments on the laboratory test LabTestComment Optional UDE

Substance Tests (Appears Up To 2 Times)

# Title Short Description Variable Name Required? Type
1 Lab test performed indicator  Indicator of whether the lab test has been performed on the participant/subject LabTestPerfInd Recommended CDE
2 Lab test LOINC code  Identifier name given to a test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. LabTestLOINCCode Recommended CDE
3 Lab test date and time  Date or Date and Time,if available and known, when the lab test was performed. LabTestDateTime Recommended CDE
4 Lab test date and time record type  Whether the lab test date and time is accurately recorded or estimated LabTestDateTimeRecTyp Recommended CDE
5 Lab test date and time record is unknown or estimated reason  Reason why of whether the lab test date and time is unknown or estimated. LabTestDateTimeUnknownRsn Recommended CDE
6 Lab specimen collection date and time  Date (and time if applicable and known) when the specimen was collected LabSpecmnCollDateTime Recommended CDE
7 Drug screen sample type  Type of sample used to perform the toxic drug screen DrgScrnSamplTyp Recommended CDE
8 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
9 Drug screen qualitative result  Overall result of toxic drug screen DrgScrnQualReslt Recommended CDE
10 Drug screen positive substance type  Type of substance(s) found positive in overall toxic drug screen DrgScrnPosSubstncTyp Recommended CDE
11 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
12 Alcohol blood test performed indicator  Indicator of whether blood alcohol test was performed AlchBldTstPerformInd Recommended CDE
13 Alcohol blood level measurement  Measurement of blood alcohol content (mg/100 ml blood) AlchBldLvlMeasr Recommended CDE
14 Data acquisition location type  Type of location where subject data were taken DataAcquisitionLocationTyp Optional CDE
15 Data acquisition location type other text  The free-text field related to Data acquisition location type, specifying other text. Type of location where the subject data were taken DataAcquisitionLocationOTH Optional CDE
16 Lab test comment  Comments on the laboratory test LabTestComment Optional UDE

LabPanel (Appears Up To 4 Times)

# Title Short Description Variable Name Required? Type
1 Lab panel category  Category or panel of lab tests, often logically grouped according to type of testing (Hematology, Chemistry, Urinalysis) or specimen type (Blood, Urine, CSF) LabPanelCat Optional CDE
2 Lab panel other text  The free-text field related to 'Lab panel category' specifying other text. Category or panel of lab tests, often logically grouped according to type of testing (Hematology, Chemistry, Urinalysis) or specimen type (Blood, Urine, CSF) LabPanelOTH Optional CDE
3 Data collected date and time  Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination, report, or the procedure performed. DataCollDateTime Optional CDE
4 Specimen accession number  Number with which the specimen taken for the tests being reported was accessioned to the record storage facility SpecmnAcssnNum Optional CDE

 Change History

 Administrative Change History