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| Metadataspec |
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| Num | Field Category | Target Tabulation Variable | Implementation |
|---|
| 1 | Data cleaning | NA | The field --YN with Question Text "Were there any [interventions/events/findings]?" can be used for this purpose. Replace the 2 dashes (--) with the 2-character domain code and create the question text or prompt using generic question text or prompts from the CDASH Model as a base. Always create custom data-cleaning/operational variables using consistent naming conventions. | | 2 | Direct mapping | Yes | If a value can be collected exactly as it will be reported in the tabulation dataset (i.e., same value, same data type, same meaning, same controlled terminology), the tabulation variable name will be used as the data collection variable name in the operational database to streamline the mapping process. Characters may be appended to the data collection variable name | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-412 |
|---|
|
if needed to create a unique variable name in the collection database. Any collection variable whose meaning is the same as tabulation variable will align with tabulation variable and the meaning will not be modified for data collection. | | 3 | No direct mapping
| Yes | If a value cannot be collected in alignment with the tabulation dataset variable (e.g., collected data type is different from the data type in the corresponding tabulation variable) or if the tabulation variable is derived from the collected value, then the operational database should use a collection variable with a different name from tabulation variable into which it will be mapped. | No | If a field does not align with a tabulation variable, a unique name should be assigned based on applicant business rules using CDASH naming fragments (e.g., --DAT, --TIM) as appropriate and CDISC variable naming fragments, found in the CDISC NSV Registry | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-413 |
|---|
|
, where possible. |
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If data to be collected are not in scope for a domain in this guide, a custom domain can be used. An existing domain may help in selecting the fields and terminology needed for the custom domain. The custom domain must be based on one of the SDTM general observation classes. See Section 2.8.3 How to Create New Specifications for further information.
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