SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. 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 "SM". | ||||
| 3 | USUBJID | Unique Subject Identifier | Char | Identifier | C69256 | A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product. | |||||
| 4 | SMSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records. Should be assigned to be consistent with chronological order. | ||||||
| 5 | MIDS | Disease Milestone Instance Name | Char | Topic | Name of the specific disease milestone. For disease milestones that can occur multiple times, the name will end with a sequence number. | "HYPO1" | |||||
| 6 | MIDSTYPE | Disease Milestone Type | Char | Record Qualifier | | | The type of disease milestone. | "HYPOGLYCEMIC EVENT" | ||||
| 7 | SMSTDTC | Start Date/Time of Milestone | Char | ISO 8601 datetime or interval | Timing | Start date or start date and time of milestone instance (if milestone is an intervention or event), or date of milestone if the milestone is a finding. | |||||
| 8 | SMENDTC | End Date/Time of Milestone | Char | ISO 8601 datetime or interval | Timing | End date/time of disease milestone Instance. | |||||
| 9 | SMSTDY | Study Day of Start of Milestone | Num | Timing | Study day of start of disease milestone instance, relative to the sponsor-defined RFSTDTC. | ||||||
| 10 | SMENDY | Study Day of End of Milestone | Num | Timing | Study day of end of disease milestone instance, relative to the sponsor-defined RFSTDTC. |
Metadata Checks Findings
SDTM & Related IG Metadata Check User Macros FAQ
- Content: For variable MIDSTYPE, Definition does not have an ending period
SDTM v2.0 Metadata Check for Class and Dataset Specification Table 1.4.0
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 "SM". | ||||
| 3 | USUBJID | Unique Subject Identifier | Char | Identifier | C69256 | A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product. | |||||
| 4 | SMSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records. Should be assigned to be consistent with chronological order. | ||||||
| 5 | MIDS | Disease Milestone Instance Name | Char | Topic | Name of the specific disease milestone. For disease milestones that can occur multiple times, the name will end with a sequence number. | "HYPO1" | |||||
| 6 | MIDSTYPE | Disease Milestone Type | Char | Record Qualifier | The type of disease milestone. | "HYPOGLYCEMIC EVENT" | |||||
| 7 | SMSTDTC | Start Date/Time of Milestone | Char | ISO 8601 datetime or interval | Timing | Start date or start date and time of milestone instance (if milestone is an intervention or event), or date of milestone if the milestone is a finding. | |||||
| 8 | SMENDTC | End Date/Time of Milestone | Char | ISO 8601 datetime or interval | Timing | End date/time of disease milestone Instance. | |||||
| 9 | SMSTDY | Study Day of Start of Milestone | Num | Timing | Study day of start of disease milestone instance, relative to the sponsor-defined RFSTDTC. | ||||||
| 10 | SMENDY | Study Day of End of Milestone | Num | Timing | Study day of end of disease milestone instance, relative to the sponsor-defined RFSTDTC. |
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