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Description/Overview

The CDASHIG LB domain contains laboratory test data, for tests and measurements performed on collected biological specimens. The LB domain includes but is not limited to hematology, clinical chemistry, and urinalysis data. The LB domain does not include microbiology or pharmacokinetic data, which are represented in separate domains (MB and PP, respectively). CDASH does not specify the actual lab parameters that should be collected.

This section describes 3 different data collection scenarios for laboratory test results. It is up to the sponsor to determine which data collection scenario best meets the study needs.

Scenario 1: Central Processing 

In this scenario, subject specimens are taken at the site and sent out for processing. Results are provided in an electronic file; the sponsor has chosen to collect reconciliation data (e.g., LBDAT, LBTIM, VISITNUM, LBREFID) on the CRF. This scenario may also apply if the central lab results are imported into a sponsor's electronic data collection (EDC) system. The fields for test results are not defined here, as these data are not part of the CRF.

Scenario 2: Central Processing with Investigator Assessment of Clinical Significance Assessment for Abnormal Values 

In this scenario, subject specimens are taken at the site and sent to a central lab for processing. The results are provided in an electronic file to the sponsor. In addition, the results are provided to the investigator for assessment of clinical significance for any abnormal values, and that information is provided to the sponsor on the CRF.

Scenario 3: Local Processing 

In this scenario, subject specimens are taken and analyzed, and then the results are recorded directly on the CRF.

Specification

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Observation ClassDomainData Collection ScenarioImplementation OptionsOrder NumberCollection VariableCollection Variable LabelDRAFT Collection DefinitionQuestion TextPromptData TypeCollection CoreCase Report Form Completion InstructionsTabulation TargetMapping InstructionsControlled Terminology Codelist NameSubset Controlled Terminology/CDASH Codelist NameImplementation Notes
FindingsLBCentral ProcessingN/A1STUDYIDStudy IdentifierA unique identifier for a study.What is the study identifier?[Protocol/Study]CharHRN/ASTUDYIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AAlthough this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.
FindingsLBCentral ProcessingN/A2SITEIDStudy Site IdentifierA unique identifier for a site within a study.What is the site identifier?Site (Identifier)CharHRN/ADM.SITEIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/A

Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site.

EDC: This should be pre-populated.

FindingsLBCentral ProcessingN/A3SUBJIDSubject Identifier for the StudyA unique subject identifier within a site and a study.What [is/was] the (study) [subject/participant] identifier?[Subject/Participant] (Identifier)CharHRRecord the identifier for the subject.DM.SUBJIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/A

Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.

FindingsLBCentral ProcessingN/A4VISITVisit NameThe name of an encounter that encompasses planned and unplanned study interventions, procedures, and assessments that may be performed on a subject.What is the visit name?[Visit]CharR/CN/AVISITMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThe name of the clinical encounter is typically pre-printed on the CRF or displayed in the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.
FindingsLBCentral ProcessingN/A5VISDATVisit DateDate the encounter occurred (or started).What [is/was] the date of the visit?(Visit) DateCharR/CRecord the [date/start date] of the visit using DD-MON-YYYY format.N/AThis field is not a tabulation variable. The date of a measurement, test, observation, or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable LBDTC in ISO 8601 format.N/AN/AThe date the laboratory specimens were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the laboratory tests at that visit, or the specimen collection date can be collected on the Laboratory CRF using the date (LBDAT) field.
FindingsLBCentral ProcessingN/A6LBPERFLab PerformedAn indication of whether a planned lab measurement, series of lab measurements, tests, observations or was performed or specimens collected.Was the sample collected?; Was the lab performed?Lab Performed; Sample CollectedCharHRIndicate whether or not lab specimen was collected or measurement performed.LBSTATThis does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable LBSTAT. If the collection variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null. A combination of tabulation variables ( e.g., LBCAT and LBSCAT, LBTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable LBTESTCD would be populated as LBALL and an appropriate test name (LBTEST) provided.(NY)N/AThis may be implemented for an entire lab panel, or a specific lab test. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.
FindingsLBCentral ProcessingN/A7LBDATSpecimen Collection DateThe date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).What was the (start) date of the lab specimen collection?Specimen Collection (Start) DateCharR/CRecord the (start) date when specimen collection was done using this format (DD-MON-YYYY).LBDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable LBDTC in ISO 8601 format.N/AN/AA complete date is expected. The date of specimen collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required. The tabulation LBDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.
FindingsLBCentral ProcessingN/A8LBTIMSpecimen Collection TimeThe time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).What was the (start) time of the lab specimen collection?Specimen Collection (Start) TimeCharR/CRecord the (start) time of collection (as complete as possible).LBDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable LBDTC in ISO 8601 format.N/AN/AMay be required when multiple assessments are done on 1 day or when the timing in relationship to study product is required for analysis or a specimen is collected over an extended time period.
FindingsLBCentral ProcessingN/A9LBCATCategory for Lab TestA grouping of topic-variable values based on user-defined characteristics.What was the name of the lab panel?[Lab Panel Name]; NULLCharR/CRecord the lab test category, if not pre-printed on the CRF.LBCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included in the column heading. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBCAT and or LBSCAT should be included if lab status (NOT DONE) is collected for each lab category/subcategory (e.g., HEMATOLOGY, CHEMISTRY, URINALYSIS).
FindingsLBCentral ProcessingN/A10LBSCATSubcategory for Lab TestA sub-division of the LBCAT values based on user-defined characteristics.

What was the name of the lab sub-panel?

[Lab Sub-Panel Name]; NULLCharR/CRecord the lab test subcategory, if not pre-printed on the CRF.LBSCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-defined controlled terminology (e.g. electrolytes, liver function). This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBSCAT can only be used if there is an LBCAT, and it must be a subcategorization of LBCAT.
FindingsLBCentral ProcessingN/A11LBTPTLab Planned Time Point NameA text description of planned time point when measurements should be taken, as defined in the protocol.What was the planned time point of the lab?[Planned Time Point Name]CharR/CRecord the planned time point labels for the lab test, if not pre-printed on the CRF.LBTPTMaps directly to the tabulation variable listed in the Tabulation Target column. Tabulation time-point anchors LBTPTREF (text description) and LBRFTDTC (date/time) may be needed, as well as tabulation variables LBTPTNUM, LBELTM.N/AN/APlanned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Planned Time Point" can be included in the column heading.
FindingsLBCentral ProcessingN/A12LBCONDLab Test Condition MetIndication whether the testing conditions defined in the protocol were met (e.g., low-fat diet).Were the protocol-defined testing conditions met?Test Condition MetCharR/CRecord whether protocol defined testing conditions were met.SUPPLB.QVALThis does not map directly to a tabulation variable. This information could be submitted in a SUPPLB dataset as the value of SUPPLB.QVAL where SUPPLB.QNAM ="LBCOND" and SUPPLB.LABEL="Test Condition Met".(NY)N/AThis information is collected when the laboratory test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF. This may not be relevant for all tests.
FindingsLBCentral ProcessingN/A13LBFAST

Lab Fasting Status TOBA-198 - Getting issue details... STATUS

An indication that the subject has abstained from food/water for the specified amount of time.Was the subject fasting?FastingCharR/CRecord whether the subject was fasting prior to the test being performed.LBFASTMaps directly to the tabulation variable listed in the Tabulation Target column.(NY)N/AResults may be affected by whether the subject was fasting. This may not be relevant for all tests.
FindingsLBCentral ProcessingN/A14LBREFIDLab Specimen IDAn internal or external identifier (e.g., specimen identifier).What was the (laboratory test) [reference identifier/accession number]?(Laboratory) [Reference identifier/Accession Number]CharR/CRecord the specimen or accession number assigned.LBREFIDMaps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.N/AN/AThis can be used to confirm that the appropriate data record is present in the electronic transfer. May be included for linking back to specimens (e.g., Specimen ID).
FindingsLBCentral Processing with CSN/A1STUDYIDStudy IdentifierA unique identifier for a study.What is the study identifier?[Protocol/Study]CharHRN/ASTUDYIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AAlthough this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation before submission.
FindingsLBCentral Processing with CSN/A2SITEIDStudy Site IdentifierA unique identifier for a site within a study.What is the site identifier?Site (Identifier)CharHRN/ADM.SITEIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/A

Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site.

EDC: This should be pre-populated.

FindingsLBCentral Processing with CSN/A3SUBJIDSubject Identifier for the StudyA unique subject identifier within a site and a study.What [is/was] the (study) [subject/participant] identifier?[Subject/Participant] (Identifier)CharHRRecord the identifier for the subject.DM.SUBJIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/A

Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.

FindingsLBCentral Processing with CSN/A4VISITVisit NameThe name of an encounter that encompasses planned and unplanned study interventions, procedures, and assessments that may be performed on a subject.What is the visit name?[Visit]CharR/CN/AVISITMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThe name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.
FindingsLBCentral Processing with CSN/A5VISDATVisit DateDate the encounter occurred (or started).What [is/was] the date of the visit?(Visit) DateCharR/CRecord the [date/start date] of the visit using DD-MON-YYYY format.N/AThis field is not a tabulation variable. The date of a measurement, test, observation, or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable LBDTC in ISO 8601 format.N/AN/AThe date of the laboratory specimens were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the laboratory tests at that visit, or the collection date can be collected on the Laboratory CRF using the date (LBDAT) field
FindingsLBCentral Processing with CSN/A6LBPERFLab PerformedAn indication of whether a planned lab measurement, series of lab measurements, test, or observation was performed or specimens collected.Was the sample collected?; Was the lab performed?Lab Performed; Sample CollectedCharHRIndicate whether or not lab specimen was collected or measurement performed.LBSTATThis does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable LBSTAT. If the collection variable LBPERF="N", the value of LBSTAT will be "NOT DONE". If LBPERF="Y", LBSTAT should be null. A combination of tabulation variables (e.g., LBCAT and LBSCAT, LBTPT ) is used to indicate that multiple tests were not done. In this situation, the tabulation variable LBTESTCD would be populated as LBALL and an appropriate test name (LBTEST) provided.(NY)N/AThis may be implemented for an entire lab panel, or a specific lab test. This general prompt question is used as a data management tool to verify that missing results are confirmed missing.
FindingsLBCentral Processing with CSN/A7LBDATSpecimen Collection DateThe date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).What was the (start) date of the lab specimen collectionSpecimen Collection (Start) DateCharR/CRecord the (start) date when the specimen collection was done using this format (DD-MON-YYYY).LBDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable LBDTC in ISO 8601 format.N/AN/AA complete date is expected. The date of specimen collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required. The tabulation LBDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.
FindingsLBCentral Processing with CSN/A8LBTIMSpecimen Collection TimeThe time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).What was the (start) time of the lab specimen collection?Specimen Collection (Start) TimeCharR/CRecord the (start) time of collection (as complete as possible).LBDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable LBDTC in ISO 8601 format.N/AN/AMay be required when multiple assessments are done on 1 day or when the timing in relationship to study product is required for analysis or a specimen is collected over an extended time period.
FindingsLBCentral Processing with CSN/A9LBCATCategory for Lab TestA grouping of topic-variable values based on user-defined characteristics.What was the name of the lab panel?[Lab Panel Name]; NULLCharR/CRecord the lab test category, if not pre-printed on the CRF.LBCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included as the column heading. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBCAT and or LBSCAT should be included if lab status (NOT DONE) is collected for each lab category (e.g., HEMATOLOGY, CHEMISTRY, URINALYSIS).
FindingsLBCentral Processing with CSN/A10LBSCATSubcategory for Lab TestA sub-division of the LBCAT values based on user-defined characteristics.What was the name of the lab sub-panel?[Lab Sub-Panel Name]; NULLCharR/CRecord the lab test subcategory, if not pre-printed on the CRF.LBSCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-defined controlled terminology (e.g. electrolytes, liver function). This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBSCAT can only be used if there is an LBCAT, and it must be a subcategorization of LBCAT.
FindingsLBCentral Processing with CSN/A11LBTPTLab Planned Time Point NameA text description of planned time point when measurements should be taken, as defined in the protocol.What was the planned time point of the lab?[Planned Time Point Name]CharR/CRecord the planned time-point labels for the lab test, if not pre-printed on the CRF.LBTPTMaps directly to the tabulation variable listed in the Tabulation Target column. Tabulation time-point anchors LBTPTREF (text description) and LBRFTDTC (date/time) may be needed, as well as tabulation variables LBTPTNUM, LBELTM.N/AN/APlanned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Planned Time Point" can be included in the column heading.
FindingsLBCentral Processing with CSN/A12LBCONDLab Test Condition MetIndication of whether the testing conditions defined in the protocol were met (e.g., low-fat diet).Were the protocol-defined testing conditions met?Test Condition MetCharORecord whether protocol-defined testing conditions were met.SUPPLB.QVALThis does not map directly to a tabulation variable. This information could be submitted in a SUPPLB dataset as the value of SUPPLB.QVAL where SUPPLB.QNAM ="LBCOND" and SUPPLB.LABEL="Test Condition Met".(NY)N/AThis information is collected when the laboratory test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF (e.g., "Did subject meet diet requirements?"). This may not be relevant for all tests.
FindingsLBCentral Processing with CSN/A13LBFASTLab Fasting StatusAn indication that the subject has abstained from food/water for the specified amount of time.Was the subject fasting?FastingCharR/CRecord whether the subject was fasting prior to the test being performed.LBFASTMaps directly to the tabulation variable listed in the Tabulation Target column.(NY)N/AResults may be affected by whether the subject was fasting. This may not be relevant for all tests.
FindingsLBCentral Processing with CSN/A14LBTESTLab Test or Examination NameDescriptive name of the lab test or examination used to obtain the measurement or finding. Any test normally performed by a clinical laboratory is considered a lab test.What was the lab test name?[Laboratory Test Name]CharHRRecord the name of the lab measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.LBTEST; LBTESTCDMaps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable LBTESTCD may be determined from the value collected in LBTEST. The tabulation variables LBTESTCD and LBTEST are required in the tabulation datasets. Use appropriate CDISC Controlled Terminology for the test and test code.(LBTEST)N/ARequired to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Test" can be included as the column heading.
FindingsLBCentral Processing with CSN/A15

LBORRES

Lab Result or Finding in Original UnitsResult of the measurement or finding as originally received or collected.What was the result of the lab test?(Result)CharHRRecord the laboratory test result.LBORRESMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AOptional if already provided from central lab.
FindingsLBCentral Processing with CSN/A16LBORRESULab Original UnitsThe unit of the result as originally received or collected.What was the unit of the lab result?UnitCharORecord or select the original unit in which these data were collected.LBORRESUMaps directly to the tabulation variable listed in the Tabulation Target column.(UNIT)N/AOptional if already provided from central lab or an applicant stores units separately.
FindingsLBCentral Processing with CSN/A17LBCLSIG

Lab Clinical Significance

An indication whether lab test results were clinically significant.Was this result clinically significant?Clinically SignificantCharHRRecord whether laboratory test results were clinically significant.SUPPLB.QVALThis does not map directly to a tabulation variable. This information could be submitted in a SUPPLB dataset as the value of SUPPLB.QVAL where SUPPLB.QNAM ="LBCLSIG" and SUPPLB.QLABEL="Clinically Significant".(NY)N/AKey data collected in this scenario.
FindingsLBCentral Processing with CSN/A18LBREFIDLab Specimen IDAn internal or external identifier (e.g., specimen identifier).What was the (laboratory test) [reference identifier/accession number]?(Laboratory test) [Reference identifier/Accession Number]CharR/CRecord the specimen or accession number assigned.LBREFIDMaps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.N/AN/AThis can be used to confirm that the appropriate data record is present in the electronic transfer. May be included for linking back to specimens (e.g., Specimen ID).
FindingsLBCentral Processing with CSN/A19LBMETHODLab Method of Test or ExaminationMethod of the test or examination.What was the method used for the lab test or examination?Method of Test or ExaminationCharORecord the method of test or examination.LBMETHODMaps directly to the tabulation variable listed in the Tabulation Target column.(METHOD)N/AThis information may be collected when more than 1 method is possible, and collecting the method used is necessary.
FindingsLBLocal ProcessingN/A1STUDYIDStudy IdentifierA unique identifier for a study.What is the study identifier?[Protocol/Study]CharHRN/ASTUDYIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AAlthough this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during tabulation dataset creation.
FindingsLBLocal ProcessingN/A2SITEIDStudy Site IdentifierA unique identifier for a site within a study.What is the site identifier?Site (Identifier)CharHRN/ADM.SITEIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/A

Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site.

EDC: This should be pre-populated.

FindingsLBLocal ProcessingN/A3SUBJIDSubject Identifier for the StudyA unique subject identifier within a site and a study.What [is/was] the (study) [subject/participant] identifier?[Subject/Participant] (Identifier)CharHRRecord the identifier for the subject.DM.SUBJIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/A

Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.

FindingsLBLocal ProcessingN/A4VISITVisit NameThe name of an encounter that encompasses planned and unplanned study interventions, procedures, and assessments that may be performed on a subject.What is the visit name?[Visit]CharR/CN/AVISITMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThe name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.
FindingsLBLocal ProcessingN/A5VISDATVisit DateDate the encounter occurred (or started).What [is/was] the date of the visit?(Visit) DateCharR/CRecord the [date/start date] of the visit using this format (DD-MON-YYYY).N/AThis field is not a tabulation variable. The date of a measurement, test, observation, or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable LBDTC in ISO 8601 format.N/AN/AThe date of the laboratory specimens were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the laboratory tests at that visit, or the collection date can be collected on the Laboratory CRF using the date (LBDAT) field.
FindingsLBLocal ProcessingN/A6LBPERFLab PerformedAn indication of whether a planned lab measurement, series of lab measurements, test, or observation was performed or specimens collected.Was the sample collected?; Was the lab performed?Sample Collected; Lab PerformedCharHRIndicate whether or not lab specimen was collected or measurement performed.LBSTATThis does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable LBSTAT. If the collection variable LBPERF = "N", the value of LBSTAT will be "NOT DONE". If LBPERF = "Y", LBSTAT should be null. A combination of tabulation variables (e.g., LBCAT and LBSCAT, LBTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable LBTESTCD would be populated as LBALL and an appropriate test name (LBTEST) provided.(NY)N/AThis may be implemented for an entire panel, or on a specific test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.
FindingsLBLocal ProcessingN/A7LBDATSpecimen Collection DateThe date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).What was the (start) date of the lab specimen collection?Specimen Collection (Start) DateCharR/CRecord the (start) date of specimen collection using this format (DD-MON-YYYY).LBDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable LBDTC in ISO 8601 format.N/AN/AA complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required. The tabulation LBDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.
FindingsLBLocal ProcessingN/A8LBTIMSpecimen Collection TimeThe time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).What was the (start) time of the lab specimen collection?Specimen Collection (Start) TimeCharR/CRecord the (start) time of collection (as complete as possible)LBDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable LBDTC in ISO 8601 format.N/AN/AMay be required when multiple assessments are done on 1 day or when the timing in relationship to study product is required for analysis or a specimen is collected over an extended time period.
FindingsLBLocal ProcessingN/A9LBCATCategory for Lab TestA grouping of topic-variable values based on user-defined characteristics.What was the name of the lab panel?[Lab Panel Name]; NULLCharR/CRecord the lab test category, if not pre-printed on the CRF.LBCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included as the column heading. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBCAT and or LBSCAT should be included if lab status (NOT DONE) is collected for each lab category (e.g., HEMATOLOGY, CHEMISTRY, URINALYSIS).
FindingsLBLocal ProcessingN/A10LBSCATSubcategory for Lab TestA sub-division of the LBCAT values based on user defined characteristics.What was the name of the lab sub-panel?[Lab Sub-Panel Name]; NULLCharR/CRecord the lab test subcategory, if not pre-printed on the CRF.LBSCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be applicant-defined codelist. If the form is laid out as a grid, then words such as "Subcategory" can be included as the column heading. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBSCAT can only be used if there is an LBCAT, and it must be a subcategorization of LBCAT.
FindingsLBLocal ProcessingN/A11LBTPTLab Planned Time Point NameA text description of planned time point when measurements should be taken as defined in the protocol.What was the planned time point of the lab?[Planned Time Point Name]CharR/CRecord the planned time-point labels for the lab test, if not pre-printed on the CRF.LBTPTMaps directly to the tabulation variable listed in the Tabulation Target column. Tabulation time-point anchors LBTPTREF (text description) and LBRFTDTC (date/time) may be needed, as well as tabulation variables LBTPTNUM, LBELTM.N/AN/APlanned time points are needed to differentiate multiple sequential assessments. It is recommended that time points be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Planned Time Point" can be included as the column heading.
FindingsLBLocal ProcessingN/A12LBFASTLab Fasting StatusAn indication that the subject has abstained from food/water for the specified amount of time.Was the subject fasting?FastingCharR/CRecord whether the subject was fasting prior to the test being performed.LBFASTMaps directly to the tabulation variable listed in the Tabulation Target column.(NY)N/AResults may be affected by whether the subject was fasting. This may not be relevant for all tests.
FindingsLBLocal ProcessingN/A13LBCONDLab Test Condition MetIndication of whether the testing conditions defined in the protocol were metWere the protocol-defined testing conditions met?Test Condition MetCharR/CRecord whether protocol-defined testing conditions were met.SUPPLB.QVALThis does not map directly to a tabulation variable. This information could be submitted in a SUPPLB dataset as the value of SUPPLB.QVAL where SUPPLB.QNAM = "LBCOND" and SUPPLB.LABEL="Test Condition Met".(NY)N/AThis information is collected when the laboratory test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF This may not be relevant for all tests.
FindingsLBLocal ProcessingN/A14LBSPCCNDLab Specimen ConditionDescription of the condition of the specimen.What was the condition of the specimen?Specimen ConditionCharORecord the condition of specimen.LBSPCCNDMaps directly to the tabulation variable listed in the Tabulation Target column.(SPECCOND)N/AMay be collected using free or standardized text. Results may be affected by whether conditions for specimen were properly met. When local processing is used, applicants may not routinely collect specimen condition.
FindingsLBLocal ProcessingN/A15LBTESTLab Test or Examination NameDescriptive name of the lab test or examination used to obtain the measurement or finding. Any test normally performed by a clinical laboratory is considered a lab test.What was the lab test name?[Laboratory Test Name]CharHRRecord the name of the lab measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.LBTEST; LBTESTCDMaps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable LBTESTCD may be determined from the value collected in LBTEST. The tabulation variables LBTESTCD and LBTEST are required in the tabulation datasets. Use appropriate CDISC Controlled Terminology for the test and test code.(LBTEST)N/ARequired to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field that requires the site to enter text. If the form is laid out as a grid, then words such as "Test" can be included as the column heading.
FindingsLBLocal ProcessingN/A16

LBORRES

Lab Result or Finding in Original UnitsResult of the measurement or finding as originally received or collected.What was the result of the lab test?(Result)CharHRRecord the laboratory test result.LBORRESMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/ABoth quantitative results and interpretive findings or summaries may be recorded here.
FindingsLBLocal ProcessingN/A17LBMETHODLab Method of Test or ExaminationMethod of the test or examination.What was the method used for the lab test or examination?Method of [Test/Examination]CharORecord the method of test or examination.LBMETHODMaps directly to the tabulation variable listed in the Tabulation Target column.(METHOD)N/AThis information may be collected when more than 1 method is possible, and collecting the method used is necessary.
FindingsLBLocal ProcessingN/A18LBORRESULab Original UnitsThe unit of the result as originally received or collected.What was the unit of the lab result?UnitCharR/CRecord or select the original unit in which these data were collected, if not pre-printed on CRF.LBORRESUMaps directly to the tabulation variable listed in the Tabulation Target column.(UNIT)N/AShould be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. Should be included if applicable and not available elsewhere. For some lab tests the units may not be applicable (e.g., urine color).
FindingsLBLocal ProcessingN/A19LBCRESULab Collected Non-Standard UnitThe unit of the result as originally received if it were collected as a non-standard unit.What was the unit of the lab result?UnitCharORecord or select the original unit in which these data were collected, if not pre-printed on CRF.SUPPLB.QVALThis does not map directly to a tabulation variable. The collected, nonstandard unit(s) may be submitted in a supplemental qualifier dataset.N/AN/AThe collected, nonstandard unit(s) should be reported as an equivalent standard unit in LBORRESU.
FindingsLBLocal ProcessingN/A20LBTOXGRLab Standard Toxicity GradeThe toxicity grade, using a standard toxicity scale (e.g., NCI CTCAE).What is the toxicity grade?Toxicity GradeCharORecord the toxicity grade.LBTOXGRMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis is commonly used in oncology studies, but applicants may not collect these toxicity grades on CRFs. Terminology codeslists (TOXGRV3, TOXGRV4) are available for use.
FindingsLBLocal ProcessingN/A21LBTOXLab ToxicityA description of toxicity quantified by LBTOXGR (e.g., NCI CTCAE Short Name).What is the description of the toxicity?ToxicityCharORecord the description of the toxicity.LBTOXMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis would typically be the text description quantified by LBTOXGR (e.g., HYPERCALCEMIA, HYPOCALCEMIA)
FindingsLBLocal ProcessingN/A22

LBORNRLO

Lab Ref Range Lower Limit in Orig UnitThe lower end of normal range or reference range for continuous results stored in LBORRES.What was the lower limit of the reference range for this lab test?Normal Range Lower LimitCharR/CRecord the lower limit of the reference range of the lab test.LBORNRLOMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/ALBORNRLO and LBORNRHI should be populated only for continuous results; LBSTNRC should be populated only for non-continuous results. These data may be obtained from the lab or the electronic equipment. These data could be determined from a site or lab specific set of normal ranges stored in a look-up table.
FindingsLBLocal ProcessingN/A23LBORNRHILab Ref Range Upper Limit in Orig UnitThe upper end of normal range or reference range for continuous results stored in LBORRES.What was the high limit of the reference range for this lab test?Normal Range Upper LimitCharR/CRecord the upper limit of the reference range of the lab test.LBORNRHIMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/ALBORNRLO and LBORNRHI should be populated only for continuous results; LBSTNRC should be populated only for non-continuous results. These data may be obtained from the lab or the electronic equipment. These data could be determined from a site or lab specific set of normal ranges stored in a look-up table.
FindingsLBLocal ProcessingN/A24LBNRINDLab Reference Range IndicatorAn indication or description of how the value compares to the normal range or reference range.How [did/do] the reported values compare within the [reference/normal/expected] range?Comparison to [Reference/Expected/Normal] RangeCharR/CRecord where the lab result fell with respect to the reference range (e.g. HIGH, LOW, ABNORMAL).LBNRINDMaps directly to the tabulation variable listed in the Tabulation Target column.(NRIND)N/AReference ranges may be defined by LBORNRLO and LBORNRHI or other objective criteria. Typically for local processing, "Reference Range Indicator" may be derived or determined programmatically and is not collected on the CRF. Should not be used to indicate clinical significance.
FindingsLBLocal ProcessingN/A25LBCLSIG

Lab Clinical Significance

An indication whether lab test results were clinically significant.Was this result clinically significant?Clinically SignificantCharORecord whether lab results were clinically significant.SUPPLB.QVALThis does not map directly to a tabulation variable. This information could be submitted in a SUPPLB dataset as the value of SUPPLB.QVAL where SUPPLB.QNAM= "LBCLSIG" and SUPPLB.QLABEL="Clinically Significant".(NY)N/AMay be included if required by the protocol.
FindingsLBLocal ProcessingN/A26LBNAMVendor NameThe name or identifier of the vendor (e.g., laboratory) that provided the test results.What was the name of the laboratory used?Laboratory NameCharR/CRecord the laboratory name.LBNAMMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/ARecommended to collect on the CRF if lab name was not collected at the site/study level or if multiple labs are used by a site.

Assumptions

  1. The lab parameters that should be collected are not specified by the TIG, as this is a medical and scientific decision that is based on the needs of the protocol and regulatory requirements.
  2. Applicants should decide which scenario is appropriate for each protocol.
  3. As required or defined by the study protocol, clinically significant results may need to be reported on the Medical History or Adverse Event CRF.
  4. As required or defined by the study protocol, changes that are worsening may need to be reported on the AE CRF.
  5. This is a specimen-based domain. LBDTC is the date the specimen was collected.
  6. LOINC code should not be applied to local lab data by the applicant. LOINC codes are optional and are intended to come directly from the central laboratory.

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