Variable_order | Dataset_name | Variable_name | Variable_label | Type | Codelist | Role | Core | CDISC_notes |
---|---|---|---|---|---|---|---|---|
1 | RELSPEC | STUDYID | Study Identifier | Char | Identifier | Req | Unique identifier for a study. | |
2 | RELSPEC | 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. | |
3 | RELSPEC | REFID | Specimen ID | Char | Identifier | Req | Specimen identifier, unique within USUBJID. | |
4 | RELSPEC | SPEC | Specimen Type | Char | C78734 C111114 | Variable Qualifier | Perm | Defines the type of specimen used for a measurement. Examples: "SERUM", "PLASMA", "URINE", "SOFT TISSUE". |
5 | RELSPEC | PARENT | Specimen Parent | Char | Identifier | Exp | Identifies the REFID of the parent of a specimen to support tracking its genealogy. | |
6 | RELSPEC | LEVEL | Specimen Level | Num | Variable Qualifier | Req | Identifies the generation number of the sample where the collected sample is considered the first generation. |