| 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 | SC | 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 | SC | 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 | SC | N/A | 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-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. |
| Findings | SC | N/A | N/A | 4 | VISIT | Visit Name | The 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] | 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 | SC | 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 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/A | N/A | The 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. |
| Findings | SC | N/A | N/A | 6 | SCCAT | Category for Subject Characteristic | A grouping of topic-variable values based on user-defined characteristics. | What was the category of the subject characteristics? | [Subject Characteristics Category ]; NULL | Char | O | Record the subject characteristics category, if not pre-printed on the CRF. | SCCAT | 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 "Category" can be included in the column heading. |
| Findings | SC | N/A | N/A | 7 | SCSCAT | Subcategory for Subject Characteristic | A sub-division of the SCCAT values based on user-defined characteristics. | What was the subcategory of the subject characteristics? | [Subject Characteristics Subcategory]; NULL | Char | O | Record the subject characteristics subcategory, if not pre-printed on the CRF. | SCSCAT | 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 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. |
| Findings | SC | N/A | N/A | 8 | SCPERF | SC Assessment Performed | An indication of whether any subject characteristics were collected. | Were subject characteristics collected? | Subject Characteristics Collected | Char | O | Indicate if subject characteristics information was collected. If Yes, record the appropriate details. | SCSTAT | This 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/A | General prompt question to be used as a data management tool to verify that missing results are confirmed missing. |
| Findings | SC | N/A | N/A | 9 | SCSPID | SC 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 collection 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. | SCSPID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Because 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. |
| Findings | SC | N/A | N/A | 10 | SCDAT | Subject Characteristic Collection Date | The date of collection represented in an unambiguous date format (e.g., DD-MON-YYYY). | What was the date the subject characteristics were collected? | Date | Char | R/C | Record the date the subject characteristics were collected using the format (DD-MON-YYYY). | SCDTC | This 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/A | N/A | The date of collection can be determined from a collected date of the visit (VISDAT); in such cases, a date field is not required. |
| Findings | SC | N/A | N/A | 11 | SCTEST | Subject Characteristic | Descriptive name of the subject characteristic of interest. | What is the subject characteristics name? | [Subject Characteristic Test Name] | Char | HR | Record 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/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 in the column header. |
| Findings | SC | N/A | N/A | 12 | SCORRES | SC Result or Finding in Original Units | Result of the subject characteristic as originally received or collected. | What is the subject characteristic? | (Result) | Char | HR | Record the subject characteristic. | SCORRES | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | N/A |
| Findings | SC | 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 | SC | 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 | SC | 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 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. |
| Findings | SC | N/A | Horizontal-Generic | 4 | VISIT | Visit Name | The 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] | Char | R/C | N/A | VISIT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This collection variable is typically collected in all collection domains. However, this collection variable is represented only in the tabulation DM domain. |
| Findings | SC | 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 collection VISDAT/VISTIM components and populating the tabulation variable SCDTC in ISO 8601 format. | N/A | N/A | The 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. |
| Findings | SC | N/A | Horizontal-Generic | 6 | [SCTESTCD]_SCCAT | Category for Subject Characteristic | A grouping of topic-variable values based on user-defined characteristics. | What was the category of the subject characteristics?? | [Subject Characteristics Category]; NULL | Char | O | Record the subject characteristics category, if not pre-printed on the CRF. | SCCAT | 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 "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. |
| Findings | SC | N/A | Horizontal-Generic | 7 | [SCTESTCD]_SCSCAT | Subcategory for Subject Characteristic | A sub-division of the SCCAT values based on user-defined characteristics. | What was the subcategory of the subject characteristics? | [Subject Characteristics Subcategory]; NULL | Char | O | Record the subject characteristics subcategory, if not pre-printed on the CRF. | SCSCAT | 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. 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. |
| Findings | SC | N/A | Horizontal-Generic | 8 | [SCTESTCD]_SCPERF | SC Assessment Performed | An indication of whether any subject characteristics were collected. | Were subject characteristics collected for [SCTESTCD]? | [SCTEST] Collected | Char | O | Indicate if subject characteristics information was collected. If Yes, include the appropriate details where indicated on the CRF. | SCSTAT | This 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/A | General 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. |
| Findings | SC | N/A | Horizontal-Generic | 9 | SCGRPID | Subject Characteristics Group ID | An applicant-defined identifier used to tie together a block of related records in a single domain. | What is the test group identifier? | Test Group ID | Char | O | Record unique group identifier. Applicants may insert additional instructions to ensure each record has a unique group identifier. | SCGRPID | 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 this horizontal record. This field may be populated by the applicant's data collection system. |
| Findings | SC | N/A | Horizontal-Generic | 10 | [SCTESTCD]_SCORRES | SC Result or Finding in Original Units | Result of the subject characteristics as originally received or collected. | What is the subject's [SCTEST]? | [SCTEST] Result | Char | HR | Record the subject characteristic. | SCORRES;SCTEST;SCTESTCD | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | N/A |