| 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 | VS | N/A | Horizontal-Generic | 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 | VS | N/A | Horizontal-Generic | 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 | VS | N/A | Horizontal-Generic | 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 colelction domains. However, this collection variable is populated only in the tabulation DM domain. |
| Findings | VS | N/A | Horizontal-Generic | 4 | VISIT | Visit Name | The name of a clinical encounter that encompasses planned and unplanned trial 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 | VS | N/A | Horizontal-Generic | 5 | VISDAT | Visit Date | Date the clinical 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 can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable VSDTC in ISO 8601 format. | N/A | N/A | The date the VS measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the VS CRF using the date field (VSDAT). |
| Findings | VS | N/A | Horizontal-Generic | 6 | [VSTESTCD]_VSPERF | Vital Signs Performed | An indication of whether a planned vital signs measurement, series of vital signs measurements, tests, or observations was performed. | Were [vital signs/[VSTEST] performed? | Vital Signs Performed ; [VSTEST] Performed | Char | O | Indicate if the vital signs were collected. If Yes, include the appropriate details where indicated on the CRF. | VSSTAT | This does not map directly to an tabulation variable. May be used to derive a value into the tabulation variable VSSTAT. If VSPERF="N", the value of VSSTAT will be "NOT DONE". If VSPERF="Y", VSSTAT should be null. A combination of tabulation variables (e.g., VSCAT and VSSCAT, VSTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable VSTESTCD would be populated as VSALL and an appropriate test name (VSTEST) provided. | (NY) | N/A | This general prompt question is used as a data management tool to verify that missing results are confirmed missing. This may be implemented for all tests collected on the same horizontal record or for each specific test. When mapped to the tabulation dataset, the value of VSPERF would apply to all tests on the same record. Use the collection variable [VSTESTCD]_VSPERF when implemented on a specific test basis. |
| Findings | VS | N/A | Horizontal-Generic | 7 | [VSTESTCD]_VSDAT | Vital Signs Date | The date of the vital signs measurement, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What was the date of the measurement(s)? | [VSTEST] Date | Char | R/C | Record date of measurements using this format (DD-MON-YYYY). | VSDTC | This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable VSDTC in ISO 8601 format. | N/A | N/A | A single date may be collected for all the vital sign measurements when they are performed on the same date. The date of each measurement can also be collected for each measurement using a collection variable [VSTESTCD]_VSDAT. The date of the measurements may be determined from a collected date of visit; in such cases, a separate measurement date field is not required. |
| Findings | VS | N/A | Horizontal-Generic | 8 | [VSTESTCD]_VSTIM | Vital Signs Time | The time of measurement, represented in an unambiguous time format (e.g., hh:mm:ss). | What was the time of the measurement(s)? | [VSTEST] Time | Char | R/C | Record time of measurement (as complete as possible). | VSDTC | This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable VSDTC in ISO 8601 format. | N/A | N/A | A single collection time (e.g., VSTIM) may be collected for all the measurements when they are performed at the same time. The time of each measurement can also be collected using a collection variable [VSTESTCD]_VSTIM. |
| Findings | VS | N/A | Horizontal-Generic | 9 | VSCAT | Category for Vital Signs | A grouping of topic-variable values based on user-defined characteristics. | What was the category of the vital signs? | [Vital Signs Category]; NULL | Char | O | Record the vital signs category, if not pre-printed on the CRF. | VSCAT | 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, not a question to which the site would provide an answer. If a question is asked, the response would typically be from 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. |
| Findings | VS | N/A | Horizontal-Generic | 10 | VSSCAT | Subcategory for Vital Signs | A sub-division of the VSCAT values based on user-defined characteristics. | What was the subcategory of the vital signs? | [Vital Signs Subcategory]; NULL | Char | O | Record the vital signs subcategory, if not pre-printed on the CRF. | VSSCAT | 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, 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 "Subcategory" can be included in the column header. VSSCAT can only be used if there is a VSCAT, and it must be a subcategorization of VSCAT. |
| Findings | VS | N/A | Horizontal-Generic | 11 | VSGRPID | Vital Signs Group ID | An applicant-defined identifier used to tie a block of related records in a single domain. | What is the vital signs group identifier? | Test Group ID | Char | O | Record unique group identifier. The applicant may insert additional instructions to ensure each record has a unique group identifier. | VSGRPID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | It can be beneficial to use an identifier in a data query to communicate clearly to the site the specific record in question. This group identifier ties together all the tests collected on the same horizontal record. This field may be populated by the applicant's data collection system. |
| Findings | VS | N/A | Horizontal-Generic | 12 | [VSTESTCD]_VSTPT | Vital Signs Planned Time Point Name | A text description of planned time points when measurements should be taken, as defined in the protocol. | What is the planned time point for this vital signs measurement? | [Planned Time Point Name] | Char | R/C | Record the planned time-point labels for vital signs, if not pre-printed on the CRF. | VSTPT | Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation time-point anchors VSTPTREF (text description) and VSRFTDTC (date/time) may be needed, as well as tabulation variables VSTPTNUM, VSELTM. | 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. The planned time point of each measurement can also be collected using the collection variable [VSTESTCD]_VSTPT. |
| Findings | VS | N/A | Horizontal-Generic | 13 | [VSTESTCD]_VSSTAT | Vital Signs Completion Status | This variable is used to indicate that data are not available, by having the site recording the value as "Not Done". | Indicate if the [VSTEST] measurement was not done. | Not Done | Char | O | Indicate if the vital signs measurement was not done. | VSSTAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (ND) | N/A | A single "Not Done" can be collected once for all tests on the same horizontal record using VSSTAT. The value of VSSTAT applies to all measurements on that record when mapped to the tabulation dataset. If needed, for each test "NOT DONE" may be collected using the collection variable [VSTESTCD]_VSSTAT. |
| Findings | VS | N/A | Horizontal-Generic | 14 | [VSTESTCD]_VSORRES | VS Result or Finding in Original Units | Result of the vital signs measurement as originally received or collected. | What was the result of the [VSTEST] measurement? | [VSTEST] (Result) | Char | HR | Record the vital sign results. | VSORRES; VSTEST; VSTESTCD | Maps directly to the tabulation variable listed in the Tabulation Target column. In addition to the tabulation variable VSORRES, create VSTESTCD from the collection variable name and determine the value of VSTEST from VSTESTCD. The prompt may also contain the VSTEST. Use appropriate CDISC Controlled Terminology for the test and test code. | N/A | N/A | Each test may be collected using the collection variable [TESTCD] e.g., SYSBP or [TESTCD]_VSORRES where TESTCD is the appropriate CT for the VS test code e.g., SYSBP_VSORRES. This is an examples of the types of collection variable names that can be used in a denormalized data structure. |
| Findings | VS | N/A | Horizontal-Generic | 15 | [VSTESTCD]_VSORRESU | VS Original Units | The unit of the result as originally received or collected. | What was the unit of the [VSTEST] measurement? | [VSTEST] Unit | Char | R/C | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | VSORRESU | Maps directly to the tabulation variable listed in the Tabulation Target column. | (UNIT) | N/A | A single Unit field can be collected once for all measurements collected on the same horizontal record using VSUNIT. The value of VSUNIT applies to all measurements on that record when mapped to the tabulation dataset. If needed for each measurement, unit may be collected using the collection variable [VSTESTCD]_VSORRESU. Should be pre-printed on the CRF (or enterable from a picklist) with the associated test when possible, rather than collected as free-text. |
| Findings | VS | N/A | Horizontal-Generic | 16 | [VSTESTCD]_VSCLSIG | Vital Signs Clinical Significance | An indication of whether the vital signs results were clinically significant. | Was the [VSTEST] result clinically significant? | [VSTEST] Clinically Significant | Char | O | Record whether the vital sign result was clinically significant. | SUPPVS.QVAL | This does not map directly to an tabulation variable. This information could be represented in a SUPPVS dataset as the value of SUPPVS.QVAL where SUPPVS.QNAM = "VSCLSIG" and SUPPVS.QLABEL="Clinically Significant". | (NY) | N/A | In horizontal data collection, a collection variable [VSTESTCD]_VSCLSIG may be created for each VSTESTCD and added to the CRF if needed. |
| Findings | VS | N/A | Horizontal-Generic | 17 | [VSTESTCD]_VSPOS | Vital Signs Position of Subject | The position of the subject during a measurement or examination. | What was the position of the subject during the [VSTEST] measurement? | [VSTEST] Position | Char | R/C | Record the position of subject at time of test (e.g. SITTING). | VSPOS | Maps directly to the tabulation variable listed in the Tabulation Target column. | (POSITION) | (VSPOS) | Results may be affected by whether conditions for vital signs as specified in the protocol were properly met. One common condition is the subject's position. If the protocol requires this type of information, then a collection variable [VSTESTCD]_VSPOS may be created for each VSTESTCD and added to the CRF, if needed. |
| Findings | VS | N/A | Horizontal-Generic | 18 | [VSTESTCD]_VSLOC | Location of Vital Signs Measurement | A description of the anatomical location of the subject, relevant to the collection of vital signs measurements. | What was the anatomical location where the [VSTEST] measurement was taken? | [VSTEST] Anatomical Location | Char | O | Record or select location on body where measurement was performed, if not pre-printed on CRF. | VSLOC | Maps directly to the tabulation variable listed in the Tabulation Target column. | (LOC) | N/A | Collected or pre-printed on the CRF when the applicant needs to identify the specific anatomical location (e.g., ARM for blood pressure). Applicants may collect the data using a subset list of controlled terminology on the CRF. In horizontal data collection, a collection variable [VSTESTCD]_VSLOC may be created for each VSTESTCD and added to the CRF, if needed. LAT, DIR, and PORTOT are used to further describe the anatomical location. |
| Findings | VS | N/A | Horizontal-Generic | 19 | [VSTESTCD]_VSLAT | Vital Signs Laterality | Qualifier for anatomical location, further detailing the side of the body. | What was the side of the anatomical location of the [VSTEST] measurement? | Side | Char | O | Record the side of the anatomical location of the vital signs measurement. | VSLAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (LAT) | N/A | May be pre-printed or collected when the applicant needs to identify the specific side of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF. |
| Findings | VS | N/A | 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 | VS | N/A | 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 | VS | N/A | N/A | 3 | SUBJID | Subject Identifier for the Study | A unique subject identifier within a site and a study. | What is the subject identifier? | Subject | 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 provided to the site using a pre-populated list in the system. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain. |
| Findings | VS | N/A | N/A | 4 | VISIT | Visit Name | The name of a clinical encounter that encompasses planned and unplanned trial 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 | VS | N/A | N/A | 5 | VISDAT | Visit Date | Date the clinical 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 an tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable VSDTC in ISO 8601 format. | N/A | N/A | The date the VS measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the VS CRF using the Vital Signs Date (VSDAT) field. |
| Findings | VS | N/A | N/A | 6 | VSPERF | Vital Signs Performed | An indication of whether a planned vital signs measurement, series of vital signs measurements, tests, or observations was performed. | Were vital signs performed? | Vital Signs Performed | Char | O | Indicate if vital signs were collected. If Yes, include the appropriate details where indicated on the CRF. | VSSTAT | This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable VSSTAT. If VSPERF="N", the value of VSSTAT will be "NOT DONE". If VSPERF="Y", VSSTAT should be null. A combination of tabulation variables (e.g., VSCAT and VSSCAT, VSTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable VSTESTCD would be populated as VSALL and an appropriate test name VSTEST provided. | (NY) | N/A | This general prompt question is used as a data management tool to verify that missing results are confirmed missing. |
| Findings | VS | N/A | N/A | 7 | VSDAT | Vital Signs Date | The date of the vital signs measurement, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What was the date of the vital signs measurement? | Date | Char | R/C | Record date of measurements using this format (DD-MON-YYYY). | VSDTC | This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable VSDTC in ISO 8601 format. | N/A | N/A | The date of measurement can be determined from a collected date of visit (VISDAT); in such cases, a separate measurement date field is not required. |
| Findings | VS | N/A | N/A | 8 | VSTIM | Vital Signs Time | The time of measurement, represented in an unambiguous time format (e.g., hh:mm:ss). | What was the time of the vital signs measurement? | Time | Char | R/C | Record time of measurement (as complete as possible). | VSDTC | This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable VSDTC in ISO 8601 format. | N/A | N/A | Collect time if it is relevant for the analysis. |
| Findings | VS | N/A | N/A | 9 | VSSPID | Vital Signs Applicant-Defined Identifier | An applicant-defined identifier. This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined identifier field. | [Applicant-defined question] | [Applicant defined] | Char | O | If collected on the CRF, the applicant may insert instructions to ensure each record has a unique identifier. | VSSPID | 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 | Because SPID is an applicant-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the applicant's data collection system. |
| Findings | VS | N/A | N/A | 10 | VSTPT | Vital Signs Planned Time Point Name | A text description of planned time points when measurements should be taken, as defined in the protocol. | What is the planned time point for this vital signs measurement? | [Planned Time Point Name] | Char | R/C | Record the planned time-point labels for vital signs, if not pre-printed on the CRF. | VSTPT | Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation time-point anchors VSTPTREF (text description) and VSRFTDTC (date/time) may be needed, as well as tabulation variables VSTPTNUM, VSELTM. | 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 | VS | N/A | N/A | 11 | VSCAT | Category for Vital Signs | A grouping of topic-variable values based on user-defined characteristics. | What was the category of the vital signs? | [Vital Signs Category]; NULL | Char | O | Record the vital signs category, if not pre-printed on the CRF. | VSCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be from a applicant-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included in the column heading. |
| Findings | VS | N/A | N/A | 12 | VSSCAT | Subcategory for Vital Signs | A sub-division of the VSCAT values based on user-defined characteristics. | What was the subcategory of the vital signs? | [Vital Signs Subcategory]; NULL | Char | O | Record the vital signs subcategory, if not pre-printed on the CRF. | VSSCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a applicant-defined codelist. If the form is laid out as a grid, then words such as "Subcategory" can be included in the column heading. VSSCAT can only be used if there is a VSCAT, and it must be a subcategorization of VSCAT. |
| Findings | VS | N/A | N/A | 13 | VSREPNUM | Vital Signs Repetition Number | The instance number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a time point, within a visit). | What was the repetition number within the time point for this measurement? | Repetition Number | Char | O | Record the repetition number of the measurement within the time point. | SUPPVS.QVAL | This does not map directly to an tabulation variable. This information could be represented in a SUPPVS dataset as the value of SUPPVS.QVAL where SUPPVS.QNAM= "VSREPNUM" and SUPPVS.QLABEL= "Repetition Number within time point". | N/A | N/A | The repetition number of the test/measurement within the time point may be pre-printed on the CRF (e.g., multiple measurements of blood pressure, multiple analyses of a sample). |
| Findings | VS | N/A | N/A | 14 | VSTEST | Vital Signs Test Name | Descriptive name of the test or examination used to obtain the measurement or finding. | What is the vital sign test name? | [Vital Signs Test Name] | Char | HR | Record the name of the vital sign test 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. | VSTEST; VSTESTCD | Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable VSTESTCD may be determined from the value collected in VSTEST. Both VSTESTCD and VSTEST are required in the tabulation datasets. Use appropriate CDISC Controlled Terminology for the test and test code. | (VSTEST) | N/A | Required to identify which test the result is for. It is recommended that 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 in the column heading. |
| Findings | VS | N/A | N/A | 15 | VSSTAT | Vital Signs Completion Status | This variable is used to indicate that data are not available, by having the site recording the value as "Not Done". | Indicate if the vital signs measurement was not done | Not Done | Char | O | Indicate if the vital sign measurement was not done. | VSSTAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (ND) | N/A | A Not Done checkbox, which indicates the test was NOT DONE. Typically, there would be 1 checkbox for each measurement. This field can be useful on individual VS tests to confirm that a blank result field is meant to be blank. |
| Findings | VS | N/A | N/A | 16 | VSORRES | VS Result or Finding in Original Units | Result of the vital signs measurement as originally received or collected. | What was the result of the measurement? | (Result) | Char | HR | Record the vital sign result. | VSORRES | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | N/A |
| Findings | VS | N/A | N/A | 17 | VSORRESU | VS Original Units | The unit of the result as originally received or collected. | What was the unit of the measurement? | Unit | Char | R/C | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | VSORRESU | Maps directly to the tabulation variable listed in the Tabulation Target column. | (UNIT) | N/A | This should be pre-printed on the CRF (or enterable from a picklist) with the associated test when possible, rather than collected as free-text. |
| Findings | VS | N/A | N/A | 18 | VSCLSIG | Vital Signs Clinical Significance | An indication whether the vital sign result was clinically significant. | Was the result clinically significant? | Clinically Significant | Char | O | Record whether the vital sign result was clinically significant. | SUPPVS.QVAL | This does not map directly to an tabulation variable. This information could be represented in a SUPPVS dataset as the value of SUPPVS.QVAL where SUPPVS.QNAM = "VSCLSIG" and SUPPVS.QLABEL="Clinically Significant". | (NY) | N/A | N/A |
| Findings | VS | N/A | N/A | 19 | VSLOC | Location of Vital Signs Measurement | A description of the anatomical location of the subject, relevant to the collection of vital signs measurements. | What was the anatomical location where the measurement was taken? | Anatomical Location | Char | O | Record or select location on body where measurement was performed, if not pre-printed on CRF. | VSLOC | Maps directly to the tabulation variable listed in the Tabulation Target column. | (LOC) | N/A | Collected or pre-printed when the applicant needs to identify the specific anatomical location (e.g., ARM for blood pressure). Applicants may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, and PORTOT are used to further describe the anatomical location. |
| Findings | VS | N/A | N/A | 20 | VSPOS | Vital Signs Position of Subject | The position of the subject during a measurement or examination. | What was the position of the subject during the measurement? | Position | Char | R/C | Record the position of subject at time of test (e.g., SITTING). | VSPOS | Maps directly to the tabulation variable listed in the Tabulation Target column. | (POSITION) | (VSPOS) | Results may be affected by whether conditions for vital signs, as specified in the protocol, were properly met. One common condition is the subject's position. |
| Findings | VS | N/A | N/A | 21 | VSDIR | Vital Signs Directionality | Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen. | What was the directionality of the anatomical location of the measurement? | Directionality | Char | O | Record the directionality. | VSDIR | Maps directly to the tabulation variable listed in the Tabulation Target column. | (DIR) | N/A | May be pre-printed or collected when the applicant needs to identify the directionality of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF. |
| Findings | VS | N/A | N/A | 22 | VSLAT | Vital Signs Laterality | Qualifier for anatomical location, further detailing the side of the body. | What was the side of the anatomical location of the vital signs measurement? | Side | Char | O | Record the side of the anatomical location of the vital signs measurement. | VSLAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (LAT) | N/A | May be pre-printed or collected when the applicant needs to identify the specific side of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF. |