Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 SS STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 SS DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 SS USUBJID Unique Subject Identifier Char Identifier Req Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4 SS SSSEQ Sequence Number Num Identifier Req Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5 SS SSGRPID Group ID Char Identifier Perm Used to tie together a block of related records in a single domain for a subject.
6 SS SSSPID Sponsor-Defined Identifier Char Identifier Perm 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.
7 SS SSTESTCD Status Short Name Char C124305 Topic Req 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".
8 SS SSTEST Status Name Char C124306 Synonym Qualifier Req Verbatim name of the status assessment used to obtain the finding. The value in SSTEST cannot be longer than 40 characters. Example: "Survival Status".
9 SS SSCAT Category for Assessment Char Grouping Qualifier Perm Used to categorize observations across subjects.
10 SS SSSCAT Subcategory for Assessment Char Grouping Qualifier Perm A further categorization.
11 SS SSORRES Result or Finding Original Result Char Result Qualifier Exp Result of the status assessment finding as originally received or collected.
12 SS SSSTRESC Character Result/Finding in Std Format Char C124304 Result Qualifier Exp Contains the result value for all findings, copied or derived from SSORRES in a standard format.
13 SS SSSTAT Completion Status Char C66789 Record Qualifier Perm Used to indicate a status assessment was not done. Should be null if a result exists in SSORRES.
14 SS SSREASND Reason Assessment Not Performed Char Record Qualifier Perm Describes why an assessment was not performed. Example: "Subject Refused". Used in conjunction with SSSTAT when value is "NOT DONE".
15 SS SSEVAL Evaluator Char C78735 Record Qualifier Perm 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".
16 SS VISITNUM Visit Number Num Timing Exp 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
17 SS VISIT Visit Name Char Timing Perm 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
18 SS VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of the visit based upon RFSTDTC in Demographics.
19 SS TAETORD Planned Order of Element within Arm Num Timing Perm Number that gives the planned order of the Element within the Arm.
20 SS EPOCH Epoch Char C99079 Timing Perm Epoch associated with the start date/time of the subject status assessment.
21 SS SSDTC Date/Time of Assessment Char ISO 8601 Timing Exp Date and time of the subject status assessment represented in ISO 8601 character format.
22 SS SSDY Study Day of Assessment Num Timing Perm 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.