Trial Disease Milestones is used to describe observations or activities expected to occur in the course of the disease under study, the timing of which is of interest for the study.
Trial Disease Milestones—One Record per Disease Milestone Type
SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes
| # | Variable Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STUDYID | Study Identifier | Char | Identifier | C83082 | A sequence of characters used by the sponsor to uniquely identify the study. | |||||
| 2 | DOMAIN | Domain Abbreviation | Char | Identifier | C49558 | An abbreviation for a collection of observations, with a topic-specific commonality. | 2-character abbreviation, which must be "TM". | ||||
| 3 | MIDSTYPE | Disease Milestone Type | Char | Topic | The type of disease milestone. | "HYPOGLYCEMIC EVENT" | |||||
| 4 | TMDEF | Disease Milestone Definition | Char | Variable Qualifier | MIDSTYPE | Definition of the disease milestone. | |||||
| 5 | TMRPT | Disease Milestone Repetition Indicator | Char | Record Qualifier | Indicates whether this is a disease milestone that can occur only once ("N") or one that can occur multiple times ("Y"). |
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