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Description
Laboratory Test Data (LB) is a findings domain that 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 or pharmacokinetic data, which is represented in separate domains (PC and PP, respectively).
This section describes 3 different data collection scenarios for laboratory test results. It is up to the applicant 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 applicant 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 an applicant'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 applicant. 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 applicant 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 Class | Domain | Data Collection Scenario | Implementation Options | Order Number | Collection Variable | Collection Variable Label | DRAFT Collection Definition | Question Text | Prompt | Data Type | Collection Core | Case Report Form Completion Instructions | Tabulation Target | Mapping Instructions | Controlled Terminology Codelist Name | Subset Controlled Terminology/CDASH Codelist Name | Implementation Notes |
| Findings | LB | Central Processing | N/A | 1 | STUDYID | Study Identifier | A unique identifier for a study. | What is the study identifier? | [Protocol/Study] | Char | HR | N/A | STUDYID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Although 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. |
| Findings | LB | Central Processing | N/A | 2 | SITEID | Study Site Identifier | A unique identifier for a site within a study. | What is the site identifier? | Site (Identifier) | Char | HR | N/A | DM.SITEID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/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. |
| Findings | LB | Central Processing | N/A | 3 | SUBJID | Subject Identifier for the Study | A unique subject identifier within a site and a study. | What [is/was] the (study) [subject/participant] identifier? | [Subject/Participant] (Identifier) | Char | HR | Record the identifier for the subject. | DM.SUBJID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/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. |
| Findings | LB | Central Processing | N/A | 4 | VISIT | Visit Name | The 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] | Char | R/C | N/A | VISIT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | The 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. |
| Findings | LB | Central Processing | N/A | 5 | VISDAT | Visit Date | Date the encounter occurred (or started). | What [is/was] the date of the visit? | (Visit) Date | Char | R/C | Record the [date/start date] of the visit using DD-MON-YYYY format. | N/A | This 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/A | N/A | The 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. |
| Findings | LB | Central Processing | N/A | 6 | LBPERF | Lab Performed | An 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 Collected | Char | HR | Indicate whether or not lab specimen was collected or measurement performed. | LBSTAT | This 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/A | This 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. |
| Findings | LB | Central Processing | N/A | 7 | LBDAT | Specimen Collection Date | The 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) Date | Char | R/C | Record the (start) date when specimen collection was done using this format (DD-MON-YYYY). | LBDTC | This 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/A | N/A | A 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. |
| Findings | LB | Central Processing | N/A | 8 | LBTIM | Specimen Collection Time | The 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) Time | Char | R/C | Record the (start) time of collection (as complete as possible). | LBDTC | This 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/A | N/A | May 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. |
| Findings | LB | Central Processing | N/A | 9 | LBCAT | Category for Lab Test | A grouping of topic-variable values based on user-defined characteristics. | What was the name of the lab panel? | [Lab Panel Name]; NULL | Char | R/C | Record the lab test category, if not pre-printed on the CRF. | LBCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-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). |
| Findings | LB | Central Processing | N/A | 10 | LBSCAT | Subcategory for Lab Test | A sub-division of the LBCAT values based on user-defined characteristics. | What was the name of the lab sub-panel? | [Lab Sub-Panel Name]; NULL | Char | R/C | Record the lab test subcategory, if not pre-printed on the CRF. | LBSCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-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. |
| Findings | LB | Central Processing | N/A | 11 | LBTPT | Lab Planned Time Point Name | A 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] | Char | R/C | Record the planned time point labels for the lab test, if not pre-printed on the CRF. | LBTPT | Maps 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/A | N/A | Planned 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. |
| Findings | LB | Central Processing | N/A | 12 | LBCOND | Lab Test Condition Met | Indication whether the testing conditions defined in the protocol were met (e.g., low-fat diet). | Were the protocol-defined testing conditions met? | Test Condition Met | Char | R/C | Record whether protocol defined testing conditions were met. | SUPPLB.QVAL | This 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/A | This 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. |
| Findings | LB | Central Processing | N/A | 13 | LBFAST | 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? | Fasting | Char | R/C | Record whether the subject was fasting prior to the test being performed. | LBFAST | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | Results may be affected by whether the subject was fasting. This may not be relevant for all tests. |
| Findings | LB | Central Processing | N/A | 14 | LBREFID | Lab Specimen ID | An internal or external identifier (e.g., specimen identifier). | What was the (laboratory test) [reference identifier/accession number]? | (Laboratory) [Reference identifier/Accession Number] | Char | R/C | Record the specimen or accession number assigned. | LBREFID | Maps 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/A | N/A | This 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). |
| Findings | LB | Central Processing with CS | N/A | 1 | STUDYID | Study Identifier | A unique identifier for a study. | What is the study identifier? | [Protocol/Study] | Char | HR | N/A | STUDYID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Although 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. |
| Findings | LB | Central Processing with CS | N/A | 2 | SITEID | Study Site Identifier | A unique identifier for a site within a study. | What is the site identifier? | Site (Identifier) | Char | HR | N/A | DM.SITEID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/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. |
| Findings | LB | Central Processing with CS | N/A | 3 | SUBJID | Subject Identifier for the Study | A unique subject identifier within a site and a study. | What [is/was] the (study) [subject/participant] identifier? | [Subject/Participant] (Identifier) | Char | HR | Record the identifier for the subject. | DM.SUBJID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/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. |
| Findings | LB | Central Processing with CS | N/A | 4 | VISIT | Visit Name | The 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] | Char | R/C | N/A | VISIT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | The 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. |
| Findings | LB | Central Processing with CS | N/A | 5 | VISDAT | Visit Date | Date the encounter occurred (or started). | What [is/was] the date of the visit? | (Visit) Date | Char | R/C | Record the [date/start date] of the visit using DD-MON-YYYY format. | N/A | This 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/A | N/A | The 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 |
| Findings | LB | Central Processing with CS | N/A | 6 | LBPERF | Lab Performed | An 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 Collected | Char | HR | Indicate whether or not lab specimen was collected or measurement performed. | LBSTAT | This 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/A | This 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. |
| Findings | LB | Central Processing with CS | N/A | 7 | LBDAT | Specimen Collection Date | The 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) Date | Char | R/C | Record the (start) date when the specimen collection was done using this format (DD-MON-YYYY). | LBDTC | This 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/A | N/A | A 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. |
| Findings | LB | Central Processing with CS | N/A | 8 | LBTIM | Specimen Collection Time | The 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) Time | Char | R/C | Record the (start) time of collection (as complete as possible). | LBDTC | This 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/A | N/A | May 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. |
| Findings | LB | Central Processing with CS | N/A | 9 | LBCAT | Category for Lab Test | A grouping of topic-variable values based on user-defined characteristics. | What was the name of the lab panel? | [Lab Panel Name]; NULL | Char | R/C | Record the lab test category, if not pre-printed on the CRF. | LBCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-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). |
| Findings | LB | Central Processing with CS | N/A | 10 | LBSCAT | Subcategory for Lab Test | A sub-division of the LBCAT values based on user-defined characteristics. | What was the name of the lab sub-panel? | [Lab Sub-Panel Name]; NULL | Char | R/C | Record the lab test subcategory, if not pre-printed on the CRF. | LBSCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-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. |
| Findings | LB | Central Processing with CS | N/A | 11 | LBTPT | Lab Planned Time Point Name | A 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] | Char | R/C | Record the planned time-point labels for the lab test, if not pre-printed on the CRF. | LBTPT | Maps 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/A | N/A | Planned 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. |
| Findings | LB | Central Processing with CS | N/A | 12 | LBCOND | Lab Test Condition Met | Indication 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 Met | Char | O | Record whether protocol-defined testing conditions were met. | SUPPLB.QVAL | This 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/A | This 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. |
| Findings | LB | Central Processing with CS | N/A | 13 | LBFAST | Lab Fasting Status | An indication that the subject has abstained from food/water for the specified amount of time. | Was the subject fasting? | Fasting | Char | R/C | Record whether the subject was fasting prior to the test being performed. | LBFAST | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | Results may be affected by whether the subject was fasting. This may not be relevant for all tests. |
| Findings | LB | Central Processing with CS | N/A | 14 | LBTEST | Lab Test or Examination Name | Descriptive 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] | Char | HR | Record 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; LBTESTCD | Maps 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/A | Required 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. |
| Findings | LB | Central Processing with CS | N/A | 15 | LBORRES | Lab Result or Finding in Original Units | Result of the measurement or finding as originally received or collected. | What was the result of the lab test? | (Result) | Char | HR | Record the laboratory test result. | LBORRES | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Optional if already provided from central lab. |
| Findings | LB | Central Processing with CS | N/A | 16 | LBORRESU | Lab Original Units | The unit of the result as originally received or collected. | What was the unit of the lab result? | Unit | Char | O | Record or select the original unit in which these data were collected. | LBORRESU | Maps directly to the tabulation variable listed in the Tabulation Target column. | (UNIT) | N/A | Optional if already provided from central lab or an applicant stores units separately. |
| Findings | LB | Central Processing with CS | N/A | 17 | LBCLSIG | Lab Clinical Significance | An indication whether lab test results were clinically significant. | Was this result clinically significant? | Clinically Significant | Char | HR | Record whether laboratory test results were clinically significant. | SUPPLB.QVAL | This 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/A | Key data collected in this scenario. |
| Findings | LB | Central Processing with CS | N/A | 18 | LBREFID | Lab Specimen ID | An internal or external identifier (e.g., specimen identifier). | What was the (laboratory test) [reference identifier/accession number]? | (Laboratory test) [Reference identifier/Accession Number] | Char | R/C | Record the specimen or accession number assigned. | LBREFID | Maps 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/A | N/A | This 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). |
| Findings | LB | Central Processing with CS | N/A | 19 | LBMETHOD | Lab Method of Test or Examination | Method of the test or examination. | What was the method used for the lab test or examination? | Method of Test or Examination | Char | O | Record the method of test or examination. | LBMETHOD | Maps directly to the tabulation variable listed in the Tabulation Target column. | (METHOD) | N/A | This information may be collected when more than 1 method is possible, and collecting the method used is necessary. |
| Findings | LB | Local Processing | N/A | 1 | STUDYID | Study Identifier | A unique identifier for a study. | What is the study identifier? | [Protocol/Study] | Char | HR | N/A | STUDYID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Although 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. |
| Findings | LB | Local Processing | N/A | 2 | SITEID | Study Site Identifier | A unique identifier for a site within a study. | What is the site identifier? | Site (Identifier) | Char | HR | N/A | DM.SITEID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/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. |
| Findings | LB | Local Processing | N/A | 3 | SUBJID | Subject Identifier for the Study | A unique subject identifier within a site and a study. | What [is/was] the (study) [subject/participant] identifier? | [Subject/Participant] (Identifier) | Char | HR | Record the identifier for the subject. | DM.SUBJID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/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. |
| Findings | LB | Local Processing | N/A | 4 | VISIT | Visit Name | The 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] | Char | R/C | N/A | VISIT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | The 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. |
| Findings | LB | Local Processing | N/A | 5 | VISDAT | Visit Date | Date the encounter occurred (or started). | What [is/was] the date of the visit? | (Visit) Date | Char | R/C | Record the [date/start date] of the visit using this format (DD-MON-YYYY). | N/A | This 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/A | N/A | The 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. |
| Findings | LB | Local Processing | N/A | 6 | LBPERF | Lab Performed | An 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 Performed | Char | HR | Indicate whether or not lab specimen was collected or measurement performed. | LBSTAT | This 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/A | This 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. |
| Findings | LB | Local Processing | N/A | 7 | LBDAT | Specimen Collection Date | The 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) Date | Char | R/C | Record the (start) date of specimen collection using this format (DD-MON-YYYY). | LBDTC | This 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/A | N/A | A 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. |
| Findings | LB | Local Processing | N/A | 8 | LBTIM | Specimen Collection Time | The 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) Time | Char | R/C | Record the (start) time of collection (as complete as possible) | LBDTC | This 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/A | N/A | May 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. |
| Findings | LB | Local Processing | N/A | 9 | LBCAT | Category for Lab Test | A grouping of topic-variable values based on user-defined characteristics. | What was the name of the lab panel? | [Lab Panel Name]; NULL | Char | R/C | Record the lab test category, if not pre-printed on the CRF. | LBCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-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). |
| Findings | LB | Local Processing | N/A | 10 | LBSCAT | Subcategory for Lab Test | A sub-division of the LBCAT values based on user defined characteristics. | What was the name of the lab sub-panel? | [Lab Sub-Panel Name]; NULL | Char | R/C | Record the lab test subcategory, if not pre-printed on the CRF. | LBSCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-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. |
| Findings | LB | Local Processing | N/A | 11 | LBTPT | Lab Planned Time Point Name | A 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] | Char | R/C | Record the planned time-point labels for the lab test, if not pre-printed on the CRF. | LBTPT | Maps 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/A | N/A | Planned 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. |
| Findings | LB | Local Processing | N/A | 12 | LBFAST | Lab Fasting Status | An indication that the subject has abstained from food/water for the specified amount of time. | Was the subject fasting? | Fasting | Char | R/C | Record whether the subject was fasting prior to the test being performed. | LBFAST | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | Results may be affected by whether the subject was fasting. This may not be relevant for all tests. |
| Findings | LB | Local Processing | N/A | 13 | LBCOND | Lab Test Condition Met | Indication of whether the testing conditions defined in the protocol were met | Were the protocol-defined testing conditions met? | Test Condition Met | Char | R/C | Record whether protocol-defined testing conditions were met. | SUPPLB.QVAL | This 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/A | This 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. |
| Findings | LB | Local Processing | N/A | 14 | LBSPCCND | Lab Specimen Condition | Description of the condition of the specimen. | What was the condition of the specimen? | Specimen Condition | Char | O | Record the condition of specimen. | LBSPCCND | Maps directly to the tabulation variable listed in the Tabulation Target column. | (SPECCOND) | N/A | May 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. |
| Findings | LB | Local Processing | N/A | 15 | LBTEST | Lab Test or Examination Name | Descriptive 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] | Char | HR | Record 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; LBTESTCD | Maps 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/A | Required 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. |
| Findings | LB | Local Processing | N/A | 16 | LBORRES | Lab Result or Finding in Original Units | Result of the measurement or finding as originally received or collected. | What was the result of the lab test? | (Result) | Char | HR | Record the laboratory test result. | LBORRES | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Both quantitative results and interpretive findings or summaries may be recorded here. |
| Findings | LB | Local Processing | N/A | 17 | LBMETHOD | Lab Method of Test or Examination | Method of the test or examination. | What was the method used for the lab test or examination? | Method of [Test/Examination] | Char | O | Record the method of test or examination. | LBMETHOD | Maps directly to the tabulation variable listed in the Tabulation Target column. | (METHOD) | N/A | This information may be collected when more than 1 method is possible, and collecting the method used is necessary. |
| Findings | LB | Local Processing | N/A | 18 | LBORRESU | Lab Original Units | The unit of the result as originally received or collected. | What was the unit of the lab result? | Unit | Char | R/C | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | LBORRESU | Maps directly to the tabulation variable listed in the Tabulation Target column. | (UNIT) | N/A | Should 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). |
| Findings | LB | Local Processing | N/A | 19 | LBCRESU | Lab Collected Non-Standard Unit | The unit of the result as originally received if it were collected as a non-standard unit. | What was the unit of the lab result? | Unit | Char | O | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | SUPPLB.QVAL | This does not map directly to a tabulation variable. The collected, nonstandard unit(s) may be submitted in a supplemental qualifier dataset. | N/A | N/A | The collected, nonstandard unit(s) should be reported as an equivalent standard unit in LBORRESU. |
| Findings | LB | Local Processing | N/A | 20 | LBTOXGR | Lab Standard Toxicity Grade | The toxicity grade, using a standard toxicity scale (e.g., NCI CTCAE). | What is the toxicity grade? | Toxicity Grade | Char | O | Record the toxicity grade. | LBTOXGR | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This is commonly used in oncology studies, but applicants may not collect these toxicity grades on CRFs. Terminology codeslists (TOXGRV3, TOXGRV4) are available for use. |
| Findings | LB | Local Processing | N/A | 21 | LBTOX | Lab Toxicity | A description of toxicity quantified by LBTOXGR (e.g., NCI CTCAE Short Name). | What is the description of the toxicity? | Toxicity | Char | O | Record the description of the toxicity. | LBTOX | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This would typically be the text description quantified by LBTOXGR (e.g., HYPERCALCEMIA, HYPOCALCEMIA) |
| Findings | LB | Local Processing | N/A | 22 | LBORNRLO | Lab Ref Range Lower Limit in Orig Unit | The 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 Limit | Char | R/C | Record the lower limit of the reference range of the lab test. | LBORNRLO | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | LBORNRLO 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. |
| Findings | LB | Local Processing | N/A | 23 | LBORNRHI | Lab Ref Range Upper Limit in Orig Unit | The 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 Limit | Char | R/C | Record the upper limit of the reference range of the lab test. | LBORNRHI | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | LBORNRLO 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. |
| Findings | LB | Local Processing | N/A | 24 | LBNRIND | Lab Reference Range Indicator | An 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] Range | Char | R/C | Record where the lab result fell with respect to the reference range (e.g. HIGH, LOW, ABNORMAL). | LBNRIND | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NRIND) | N/A | Reference 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. |
| Findings | LB | Local Processing | N/A | 25 | LBCLSIG | Lab Clinical Significance | An indication whether lab test results were clinically significant. | Was this result clinically significant? | Clinically Significant | Char | O | Record whether lab results were clinically significant. | SUPPLB.QVAL | This 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/A | May be included if required by the protocol. |
| Findings | LB | Local Processing | N/A | 26 | LBNAM | Vendor Name | The name or identifier of the vendor (e.g., laboratory) that provided the test results. | What was the name of the laboratory used? | Laboratory Name | Char | R/C | Record the laboratory name. | LBNAM | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Recommended 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
- 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.
- Applicants should decide which scenario is appropriate for each protocol.
- As required or defined by the study protocol, clinically significant results may need to be reported on the Medical History or Adverse Event CRF.
- As required or defined by the study protocol, changes that are worsening may need to be reported on the AE CRF.
- This is a specimen-based domain. LBDTC is the date the specimen was collected.
- 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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