| 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 |
| SSSEQ |
Sequence Number |
Num |
Identifier |
Sequence Number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| SSGRPID |
Group ID |
Char |
Identifier |
Used to tie together a block of related records in a
single domain for a subject. |
Perm |
| SSSPID | Sponsor-Defined Identifier | Char | Identifier | Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number from the procedure or test page. | Perm |
| SSTESTCD |
Status Short Name |
Char |
Topic |
Short name of the status assessment described in SSTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in SSTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., “1TEST”). SSTESTCD cannot contain characters other than letters, numbers, or underscores. Example: SURVSTAT |
Req |
| SSTEST | Status Name | Char | Synonym Qualifier | Verbatim name of the status assessment used to obtain the finding. The value in SSTEST cannot be longer than 40 characters. Example: Survival Status | Req |
| SSCAT |
Category for Assessment |
Char |
Grouping Qualifier |
Used to categorize observations across subjects. |
Perm |
| SSSCAT |
Subcategory for Assessment |
Char |
Grouping Qualifier |
A further categorization. |
Perm |
| SSORRES |
Result or Finding Original Result |
Char |
Result Qualifier |
Result of the status assessment finding as originally
received or collected. |
Exp |
| SSSTRESC |
Character Result/Finding in Std Format |
Char |
Result Qualifier |
Contains the result value for all findings, copied or
derived from SSORRES in a standard format. |
Exp |
| SSSTAT |
Completion Status |
Char |
Record Qualifier |
Used to indicate a status assessment was not done. Should
be null if a result exists in SSORRES. |
Perm |
| SSREASND | Reason Assessment Not Performed | Char | Record Qualifier | Describes why an assessment was not performed. Example: SUBJECT REFUSED. Used in conjunction with SSSTAT when value is NOT DONE. | Perm |
| SSEVAL |
Evaluator |
Char |
Record Qualifier |
Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain collected or derived data. Examples: CAREGIVER, ADJUDICATION COMMITTEE, FRIEND. |
Perm |
| VISITNUM |
Visit Number |
Num |
Timing |
1. Clinical encounter number. 2. Numeric version of VISIT,
used for sorting. |
Exp |
| VISIT |
Visit Name |
Char |
Timing |
1. Protocol-defined description of clinical encounter. 2.
May be used in addition to VISITNUM and/or VISITDY. |
Perm |
| VISITDY |
Planned Study Day of Visit |
Num |
Timing |
Planned study day of the visit based upon RFSTDTC in
Demographics. |
Perm |
| SSDTC |
Date/Time of Assessment |
Char |
Timing |
|
Exp |
| SSDY | Study Day of Assessment | Num | Timing | 1. Study day of the test, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. | Perm |