| Shareqc_send4tig10_ds |
|---|
| | Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req | | DOMAIN | Domain Abbreviation | Char | DD | Identifier | Two-character abbreviation for the domain. | Req | | USUBJID | Unique Subject Identifier | Char |
| Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | | DDSEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | | DDTESTCD | Death Diagnosis Short Name | Char | (DDTESTCD) | Topic | Short name of the measurement, test, or examination described in DDTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in DDTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). DDTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | | DDTEST | Death Diagnosis Name | Char | (DDTEST) | Synonym Qualifier | Long name for DDTESTCD. The value in DDTEST cannot be longer than 40 characters. | Req | | DDORRES | Result or Findings as Collected | Char |
| Result Qualifier | Result of the diagnosis of the subject's cause of death, as originally received or collected. | Req | | DDSTRESC | Standardized Result in Character Format | Char |
| Result Qualifier | Contains the diagnosis information, copied or derived from DDORRES in a standard format. Examples: UNKNOWN, GAVAGE ERROR. | Exp | | DDRESCAT | Result Category | Char |
| Variable Qualifier | Used to categorize the result of a finding. Examples: |
TREATMENT NONTREATMENT | NON-EXPOSURE RELATED, UNDETERMINED, ACCIDENTAL, etc. | Perm | | DDEVAL | Evaluator | Char |
| Record Qualifier | Role of the person who provided the evaluation. Examples: TOX PATHOLOGIST, PEER REVIEW, |
SPONSOR, | VETERINARIAN. | Perm | | DDDTC | Date/Time | Char | ISO 8601 datetime or interval | Timing | The date/time of subject disposition, in ISO 8601 format. | Perm | | DDDY | Study Day | Num |
| Timing | Study day of subject disposition, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
|
|