| 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 preprinted 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" is not valid). 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. |
Perm |
| |
|
|
|
Examples: "CAREGIVER", "ADJUDICATION COMMITTEE", "FRIEND". |
|
| VISITNUM |
Visit Number |
Num |
Timing |
Clinical encounter number. Numeric version of VISIT, used
for sorting. |
Exp |
| VISIT |
Visit Name |
Char |
Timing |
Protocol-defined description of clinical encounter. 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 |
| TAETORD |
Planned Order of Element within Arm |
Num |
Timing |
Number that gives the planned order of the Element within
the Arm. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the start date/time of the subject
status assessment. |
Perm |
| SSDTC |
Date/Time of Assessment |
Char |
Timing |
Date and time of the subject status assessment represented
in ISO 8601 character format. |
Exp |
| SSDY |
Study Day of Assessment |
Num |
Timing |
Study day of the test, measured as integer days. Algorithm
for calculations must be relative to the sponsor-defined RFSTDTC
variable in Demographics. |
Perm |