|
SDTMIG 3.3 |
SC |
1 |
STUDYID |
Study Identifier |
Char |
|
Identifier |
Unique identifier for a study. |
Req |
|
SDTMIG 3.3 |
SC |
2 |
DOMAIN |
Domain Abbreviation |
Char |
SC |
Identifier |
Two-character abbreviation for the domain. |
Req |
|
SDTMIG 3.3 |
SC |
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 |
SC |
4 |
SCSEQ |
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 |
SC |
5 |
SCGRPID |
Group ID |
Char |
|
Identifier |
Used to tie together a block of related records in a single domain for a subject. |
Perm |
|
SDTMIG 3.3 |
SC |
6 |
SCSPID |
Sponsor-Defined Identifier |
Char |
|
Identifier |
Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. |
Perm |
|
SDTMIG 3.3 |
SC |
7 |
SCTESTCD |
Subject Characteristic Short Name |
Char |
(SCTESTCD) |
Topic |
Short name of the measurement, test, or examination described in SCTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in SCTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). SCTESTCD cannot contain characters other than letters, numbers, or underscores. Example: "MARISTAT", "NATORIG". |
Req |
|
SDTMIG 3.3 |
SC |
8 |
SCTEST |
Subject Characteristic |
Char |
(SCTEST) |
Synonym Qualifier |
Verbatim name of the test or examination used to obtain the measurement or finding. The value in SCTEST cannot be longer than 40 characters. Examples: "Marital Status", "National Origin". |
Req |
|
SDTMIG 3.3 |
SC |
9 |
SCCAT |
Category for Subject Characteristic |
Char |
|
Grouping Qualifier |
Used to define a category of related records. |
Perm |
|
SDTMIG 3.3 |
SC |
10 |
SCSCAT |
Subcategory for Subject Characteristic |
Char |
|
Grouping Qualifier |
A further categorization of the subject characteristic. |
Perm |
|
SDTMIG 3.3 |
SC |
11 |
SCORRES |
Result or Finding in Original Units |
Char |
|
Result Qualifier |
Result of the subject characteristic as originally received or collected. |
Exp |
|
SDTMIG 3.3 |
SC |
12 |
SCORRESU |
Original Units |
Char |
(UNIT) |
Variable Qualifier |
Original unit in which the data were collected. The unit for SCORRES. |
Perm |
|
SDTMIG 3.3 |
SC |
13 |
SCSTRESC |
Character Result/Finding in Std Format |
Char |
|
Result Qualifier |
Contains the result value for all findings, copied or derived from SCORRES in a standard format or standard units. SCSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in SCSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in SCORRES, and these results effectively have the same meaning, they could be represented in standard format in SCSTRESC as "NEGATIVE". |
Exp |
|
SDTMIG 3.3 |
SC |
14 |
SCSTRESN |
Numeric Result/Finding in Standard Units |
Num |
|
Result Qualifier |
Used for continuous or numeric results or findings in standard format; copied in numeric format from SCSTRESC. SCSTRESN should store all numeric test results or findings. |
Perm |
|
SDTMIG 3.3 |
SC |
15 |
SCSTRESU |
Standard Units |
Char |
(UNIT) |
Variable Qualifier |
Standardized unit used for SCSTRESC or SCSTRESN. |
Perm |
|
SDTMIG 3.3 |
SC |
16 |
SCSTAT |
Completion Status |
Char |
(ND) |
Record Qualifier |
Used to indicate that the measurement was not done. Should be null if a result exists in SCORRES. |
Perm |
|
SDTMIG 3.3 |
SC |
17 |
SCREASND |
Reason Not Performed |
Char |
|
Record Qualifier |
Describes why the observation has no result. Example: "Subject refused". Used in conjunction with SCSTAT when value is "NOT DONE". |
Perm |
|
SDTMIG 3.3 |
SC |
18 |
TAETORD |
Planned Order of Element within Arm |
Num |
|
Timing |
Number that gives the planned order of the Element within the Arm. |
Perm |
|
SDTMIG 3.3 |
SC |
19 |
EPOCH |
Epoch |
Char |
(EPOCH) |
Timing |
Epoch associated with the start date/time at which the assessment was made. |
Perm |
|
SDTMIG 3.3 |
SC |
20 |
SCDTC |
Date/Time of Collection |
Char |
ISO 8601 |
Timing |
Collection date and time of the subject characteristic represented in ISO 8601 character format. |
Perm |
|
SDTMIG 3.3 |
SC |
21 |
SCDY |
Study Day of Examination |
Num |
|
Timing |
1. Study day of collection, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. |
Perm |