1 | DD | STUDYID | Study Identifier | Char | | Identifier | Req | Unique identifier for a study. |
2 | DD | DOMAIN | Domain Abbreviation | Char | | Identifier | Req | Two-character abbreviation for the domain. |
3 | DD | USUBJID | Unique Subject Identifier | Char | | Identifier | Req | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. |
4 | DD | DDSEQ | Sequence Number | Num | | Identifier | Req | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. |
5 | DD | DDTESTCD | Death Detail Assessment Short Name | Char | | Topic | Req | 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. Examples: DIAGPRIM, DIAGSEC, DTHWIT |
6 | DD | DDTEST | Death Detail Assessment Name | Char | | Synonym Qualifier | Req | Long name for DDTESTCD. The value in DDTEST cannot be longer than 40 characters. Examples: Primary Diagnosis, Secondary Diagnosis, Was Death Witnessed? |
7 | DD | DDORRES | Result or Finding as Collected | Char | | Result Qualifier | Exp | Result of the test defined in DDTEST, as originally received or collected. |
8 | DD | DDSTRESC | Character Result/Finding in Std Format | Char | | Result Qualifier | Exp | Contains the result or finding copied or derived from DDORRES in a standard format. |
9 | DD | DDRESCAT | Result Category | Char | | Variable Qualifier | Perm | Used to categorize the result of a finding. Examples: TREATMENT RELATED, NONTREATMENT RELATED, UNDETERMINED, ACCIDENTAL |
10 | DD | DDEVAL | Evaluator | Char | C78735 | Record Qualifier | Perm | Role of the person who provided the evaluation. |
11 | DD | DDDTC | Date/Time of Collection | Char | ISO 8601 | Timing | Exp | Date/time of collection of the diagnosis or other death assessment data in ISO 8601 format. This is not necessarily the date of death. |
12 | DD | DDDY | Study Day of Collection | Num | | Timing | Perm | Study day of the collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. |