...
The SDTM is the foundation for many implementations guides.
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | SDTM-800 |
|---|
|
Implementation implementation guides. Implementation guides include particular domains based on the general observation classes. Domain specification tables describe which variables are included in the domain for a specific implementation guide. Not all variables described in the tables in this document (SDTM tables) are appropriate for all domains in all implementation guides. The SDTM includes information on variables which are not to be used in human clinical trials. Refer to the implementation guides for specific information on any identifier or timing variables that are not allowed in a particular observation class domain
. See Section 1.2, Implementation Advice for this Model.
In the tables in this document, the presence of 2 hyphens before the variable name (e.g., --TRT) is used to indicate the required use of a prefix based on the 2-character domain code. The domain code is used as a variable prefix to minimize the risk of difficulty when merging or joining domains for reporting purposes. The variable with 2 hyphens may be referred to as a "root" variable.
...