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- CRF and System Design to guide development of the CRF(s) and the underlying database structure in conformance with the standard.
- Tabulation Dataset Programming to guide the development of programs to generate tabulation datasets from compliant data.
- Data Collection FieldsField Implementation to guide implementation use of fields and facilitate creation of study-level documentation to support expected field completion fields.
for the , mapping of collected data in tabulation datasets, as well as guidance for individuals involved in data collection.
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| Num | Column | Purpose | Description | | 1 | Observation Class | Tabulation Dataset Programming | Specifies the SDTM class for the domain. | | 2 | Domain | Tabulation Dataset Programming | Specifies the 2-letter domain code. | | 3 | Data Collection Scenario | Data Collection FieldsField Implementation | Indicates when a collection field should be used based on a specific context. Values in this column should be used with values in TIG Core to determine when a field should be present on a CRF. Values in this column are: - A short description of the context in which the collection field should be present.
- N/A for when no specific context for use applies to the collection field.
| 4 | Implementation Options | Data Collection FieldsField Implementation | Indicates Specifies how to read/implement. When this column contains "Horizontal-Generic," a sampling of the CDASHIG metadata is provided as a template for the metadata of the CRF in a denormalized structure. Is this applicable to TIG specifications? | | 5 | Order Number | Data Collection FieldsField Implementation | Provides a suggested order of fields to be displayed on a CRF. | | 6 | Data Collection Variable | Tabulation Dataset Programming | Provides the data collection variable name. | | 7 | Data Collection Variable Label | Tabulation Dataset Programming | Provides the data collection variable label. | | 8 | DRAFT CDASHIG Definition | CRF and System Design | Provides a draft definition of the CDASHIG variable for understanding and proper usage | | 9 | Question Text | CRF and System Design | Provides full sentence/question forms to prompt for data. Values in this column are: - Without text in brackets or parentheses to be used as-is.
- With text in brackets to be replaced with protocol-specified verbiage.
- With text in parentheses indicating optional text.
- With text separated with a forward slash indicating optional wording.
- In Findings domains, values from the relevant CDISC CT lists must also be used to create appropriate Question Text, Prompts, and/or variable names. For example, if the question is about the subject's height, incorporate the value of "Height" from the VSTEST codelist as the prompt on the CRF, and incorporate "HEIGHT" from VSTESTCD in the variable name.
| 10 | Prompt | CRF and System Design | Provides short phrases, suitable as column headers, to prompt for data. Values in this column are phrases: - Without text in brackets or parentheses to be used as-is
- With text in brackets to be replaced with protocol-specified verbiage.
- With text in parentheses indicating optional text.
- With text with NULL indicating the prompt is not required on a CRF screen/page if not needed.
| | 11 | Data Type | Tabulation Dataset Programming | Specifies the data type of the variable. Values for in this column are: - Num for numeric data
- Char for character or alphanumeric date
| 12 | TIG Core | CRF and System Design | Specifies expectations for inclusion of fields on a CRF. Values in this column should be used with values in Data Collection Scenario to determine when a field should be present on a CRF. Values in this column are: - HR for fields which are Highly Recommended and for which a data collection field should always be on the CRF.
- R/C for fields which are Recommended/Conditional and for which a data collection field that should be on a CRF based on certain conditions.
- O for fields which are Optional and for which a data collection field is available for use.
| | 13 | Case Report Form Completion Instructions | Data Collection FieldsField Implementation | Provides recommended example instructions to support authoring of study-level documentation for instructing sites how to complete CRF fields. | | 14 | Tabulation Target | Tabulation Dataset Programming | This column provides the suggested mapping to the tabulation dataset variable. Values in this column are: - The name of the tabulation dataset variable to which the value of the data collection variable will be mapped.
- N/A for when no direct mapping to a tabulation dataset variable is available.
- SUPP–.QNAM for when a value represented in the field will be mapped to as a Supplemental Qualifier.
| | 15 | Mapping Instructions | Tabulation Dataset Programming | Provides information on the suggested mapping of the collection variable to the tabulation variable. | | 16 | Controlled Terminology Codelist Name | CRF and System Design | Specifies controlled terminology applicable to the field. Values in this column are: - Names of controlled terminology codelists with allowable terms to populate the variable. Codelist names are specified in paratheses. Multiple codelist names indicate the variable is subject to one or more of the codelists.
| | 17 | Subset Controlled Terminology/CDASH Codelist Name: | CRF and System Design | This column contains the CDISC CT or CDASH subset codelist name that may be used for that specific variable (e.g., EXDOSFRM). Link back to CT section. | 18 | Implementation Notes | CRF and System Design | Provides additional context for implementation of CRF data collection fields and mapping to tabulation datasets content may include: - Rationale
- Implementation instructions
- A description of condition(s) when the value of TIG CORE is R/C
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