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Metadataspec
Shareqc_cdash4tig10_ds
ClassFindings
PurposeFindings
DomainSC
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
FindingsSCN/AN/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.
FindingsSCN/AN/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.

FindingsSCN/AN/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-generatedprovided 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.

FindingsSCN/AN/A4VISITVisit NameThe name of a clinical 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.
FindingsSCN/AN/A5VISDATVisit DateDate the clinical 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 can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the collection VISDAT/VISTIM components and populating the tabulation variable SCDTC in ISO 8601 format.N/AN/AThe date the subject characteristics were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the subject characteristics at that visit, or the collection date can be included on the SC CRF using the date (SCDAT) field.
FindingsSCN/AN/A6SCCATCategory for Subject CharacteristicA grouping of topic-variable values based on user-defined characteristics.What was the category of the subject characteristics?[Subject Characteristics Category ]; NULLCharORecord the subject characteristics category, if not pre-printed on the CRF.SCCATMaps 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, 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.
FindingsSCN/AN/A7SCSCATSubcategory for Subject CharacteristicA sub-division of the SCCAT values based on user-defined characteristics.What was the subcategory of the subject characteristics?[Subject Characteristics Subcategory]; NULLCharORecord the subject characteristics subcategory, if not pre-printed on the CRF.SCSCATMaps 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, 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. SCSCAT can only be used if there is an SCCAT, and it must be a subcategorization of SCCAT.
FindingsSCN/AN/A8SCPERFSC Assessment PerformedAn indication of whether any subject characteristics were collected.Were subject characteristics collected?Subject Characteristics CollectedCharOIndicate if subject characteristics information was collected. If Yes, record the appropriate details.SCSTATThis does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable SCSTAT. If SCPERF="N", the value of SCSTAT will be "NOT DONE" . If SCPERF="Y", SCSTAT should be null. A combination of tabulation variables (e.g., SCCAT and SCSCAT, SCTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable SCTESTCD would be populated as SCALL and an appropriate test name (SCTEST) provided. (NY)N/AGeneral prompt question to be used as a data management tool to verify that missing results are confirmed missing.
FindingsSCN/AN/A9SCSPIDSC Applicant-Defined IdentifierAn 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 collection identifier field.

[Applicant-defined question]

[Applicant defined]CharOIf collected on the CRF, the applicant may insert instructions to ensure each record has a unique identifier.SCSPIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/ABecause SPID is a 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.
FindingsSCN/AN/A10SCDATSubject Characteristic Collection DateThe date of collection represented in an unambiguous date format (e.g., DD-MON-YYYY).What was the date the subject characteristics were collected?DateCharR/CRecord the date the subject characteristics were collected using the format (DD-MON-YYYY).SCDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected collection DATE and TIME components and populate the tabulation variable SCDTC in ISO 8601 format.N/AN/AThe date of collection can be determined from a collected date of the visit (VISDAT); in such cases, a date field is not required.
FindingsSCN/AN/A11SCTESTSubject CharacteristicDescriptive name of the subject characteristic of interest.What is the subject characteristics name?[Subject Characteristic Test Name]CharHRRecord the name of the subject characteristics 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.SCTEST; SCTESTCD

Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable SCTESTCD may be determined from the value collected in SCTEST. Use appropriate CDISC Controlled Terminology for the test and test code.

(SCTEST)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 in the column header.
FindingsSCN/AN/A12SCORRESSC Result or Finding in Original UnitsResult of the subject characteristic as originally received or collected.What is the subject characteristic?(Result)CharHRRecord the subject characteristic.SCORRESMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AN/A
FindingsSCN/AHorizontal-Generic1STUDYIDStudy IdentifierA unique identifier for a studyWhat 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.
FindingsSCN/AHorizontal-Generic2SITEIDStudy 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.

FindingsSCN/AHorizontal-Generic3SUBJIDSubject 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 provided to the site using a pre-populated list in the systemsystem-generated. This colelction collection variable is typically collected in all collection domains. However, this collection variable is populated only in the Tabulation tabulation DM domain. 

FindingsSCN/AHorizontal-Generic4VISITVisit NameThe name of a clinical 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/AThis collection variable is typically collected in all collection domains. However, this collection variable is represented only in the tabulation DM domain. 
FindingsSCN/AHorizontal-Generic5VISDATVisit DateDate the clinical 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 can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the collection VISDAT/VISTIM components and populating the tabulation variable SCDTC in ISO 8601 format.N/AN/AThe date the subject characteristics were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the subject characteristics at that visit, or the collection date can be included on the SC CRF using the date (SCDAT) field.
FindingsSCN/AHorizontal-Generic6[SCTESTCD]_SCCATCategory for Subject CharacteristicA grouping of topic-variable values based on user-defined characteristics.What was the category of the subject characteristics??[Subject Characteristics Category]; NULLCharORecord the subject characteristics category, if not pre-printed on the CRF.SCCATMaps 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, 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. This is an example of the types of collection variable names that can be used in a denormalized data structure.
FindingsSCN/AHorizontal-Generic7[SCTESTCD]_SCSCATSubcategory for Subject CharacteristicA sub-division of the SCCAT values based on user-defined characteristics.What was the subcategory of the subject characteristics?[Subject Characteristics Subcategory]; NULLCharORecord the subject characteristics subcategory, if not pre-printed on the CRF.SCSCATMaps 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, 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. SCSCAT can only be used if there is an SCCAT, and it must be a subcategorization of SCCAT. This is an example of the types of collection variable names that can be used in a denormalized data structure.
FindingsSCN/AHorizontal-Generic8[SCTESTCD]_SCPERFSC Assessment PerformedAn indication of whether any subject characteristics were collected.Were subject characteristics collected for [SCTESTCD]?[SCTEST] CollectedCharOIndicate if subject characteristics information was collected. If Yes, include the appropriate details where indicated on the CRF.SCSTATThis does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable SCSTAT. If [SCTESTCD]_SCPERF ="N", the value of SCSTAT will be "NOT DONE". If [SCTESTCD]_SCPERF ="Y", SCSTAT should be null. A combination of tabulation variables (e.g., SCCAT and SCSCAT, SCTPT ) is used to indicate that multiple tests were not done. In this situation, the tabulation variable SCTESTCD would be assigned SCALL and an appropriate test name ( SCTEST) provided. (NY)N/AGeneral prompt question to be 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 the tabulation datasets are created, the value of SCPERF would apply to all tests on the same record. Use the collection variable [SCTESTCD]_SCPERF when implemented on a specific test basis. This is an example of the types of collection variable names that can be used in a denormalized data structure.
FindingsSCN/AHorizontal-Generic9SCGRPIDSubject Characteristics Group IDAn applicant-defined identifier used to tie together a block of related records in a single domain.What is the test group identifier?Test Group IDCharORecord unique group identifier. Applicants may insert additional instructions to ensure each record has a unique group identifier.SCGRPIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AIt 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 this horizontal record. This field may be populated by the applicant's data collection system.
FindingsSCN/AHorizontal-Generic10[SCTESTCD]_SCORRESSC Result or Finding in Original UnitsResult of the subject characteristics as originally received or collected.What is the subject's [SCTEST]?[SCTEST] ResultCharHRRecord the subject characteristic.SCORRES;SCTEST;SCTESTCDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AN/A