| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
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 Detail Assessment Short Name |
Char |
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. Examples:
"PRCDTH", "SECDTH". |
Req |
| DDTEST |
Death Detail Assessment Name |
Char |
Synonym Qualifier |
Long name for DDTESTCD. The value in DDTEST cannot be longer
than 40 characters. Examples: "Primary Cause of Death", "Secondary
Cause of Death". |
Req |
| DDORRES |
Result or Finding as Collected |
Char |
Result Qualifier |
Result of the test defined in DDTEST, as originally received
or collected. |
Exp |
| DDSTRESC |
Character Result/Finding in Std Format |
Char |
Result Qualifier |
Contains the result or finding copied or derived from
DDORRES in a standard format. |
Exp |
| DDRESCAT |
Result Category |
Char |
Variable Qualifier |
Used to categorize the result of a finding. Examples:
"TREATMENT RELATED", "NONTREATMENT RELATED", "UNDETERMINED",
"ACCIDENTAL". |
Perm |
| DDEVAL |
Evaluator |
Char |
Record Qualifier |
Role of the person who provided the evaluation. |
Perm |
| DDDTC |
Date/Time of Collection |
Char |
Timing |
Date/time of collection of the diagnosis or other death
assessment data in ISO 8601 format. This is not necessarily the date
of death. |
Exp |
| DDDY |
Study Day of Collection |
Num |
Timing |
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. |
Perm |