|
SDTMIG 3.3 |
DD |
1 |
STUDYID |
Study Identifier |
Char |
|
Identifier |
Unique identifier for a study. |
Req |
|
SDTMIG 3.3 |
DD |
2 |
DOMAIN |
Domain Abbreviation |
Char |
DD |
Identifier |
Two-character abbreviation for the domain. |
Req |
|
SDTMIG 3.3 |
DD |
3 |
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 |
|
SDTMIG 3.3 |
DD |
4 |
DDSEQ |
Sequence Number |
Num |
|
Identifier |
Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. |
Req |
|
SDTMIG 3.3 |
DD |
5 |
DDTESTCD |
Death Detail Assessment Short Name |
Char |
(DTHDXCD) |
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 |
|
SDTMIG 3.3 |
DD |
6 |
DDTEST |
Death Detail Assessment Name |
Char |
(DTHDX) |
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 |
|
SDTMIG 3.3 |
DD |
7 |
DDORRES |
Result or Finding as Collected |
Char |
|
Result Qualifier |
Result of the test defined in DDTEST, as originally received or collected. |
Exp |
|
SDTMIG 3.3 |
DD |
8 |
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 |
|
SDTMIG 3.3 |
DD |
9 |
DDRESCAT |
Result Category |
Char |
|
Variable Qualifier |
Used to categorize the result of a finding. Examples: "TREATMENT RELATED", "NONTREATMENT RELATED", "UNDETERMINED", "ACCIDENTAL". |
Perm |
|
SDTMIG 3.3 |
DD |
10 |
DDEVAL |
Evaluator |
Char |
(EVAL) |
Record Qualifier |
Role of the person who provided the evaluation. |
Perm |
|
SDTMIG 3.3 |
DD |
11 |
DDDTC |
Date/Time of Collection |
Char |
ISO 8601 |
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 |
|
SDTMIG 3.3 |
DD |
12 |
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 |