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TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1
Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes
| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
| DOMAIN | Domain Abbreviation | Char | OM | 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 | |
| OMSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
| OMTESTCD | Test Short Name | Char | (OMTESTCD) | Topic | Short name of the measurement, test, or examination described in OMTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in OMTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). OMTESTCD cannot contain characters other than letters, numbers, or underscores. | Req |
| OMTEST | Test Name | Char | (OMTEST) | Synonym Qualifier | Long name for OMTESTCD. The value in OMTEST cannot be longer than 40 characters. | Req |
| OMORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | |
| OMORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list. | Exp |
| OMSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from OMORRES in a standard format or in standard units. OMSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in OMSTRESN. | Exp | |
| OMSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of OMSTRESC. OMSTRESN should store all numeric test results or findings. | Exp | |
| OMSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for OMSTRESC and OMSTRESN. | Exp |
| OMSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in OMORRES. | Perm |
| OMREASND | Reason Not Done | Char | Record Qualifier | Describes why OMSTAT is NOT DONE, such as BROKEN EQUIPMENT or TECHNICIAN OVERSIGHT. | Perm | |
| OMSPEC | Specimen Material Type | Char | (SPEC) | Record Qualifier | Defines the type of tissue, organ, or fluid specimen used as the object for the finding. Examples: GLAND, ADRENAL, KIDNEY, VESSEL, LYMPHATIC. | Req |
| OMANTREG | Anatomical Region of Specimen | Char | Variable Qualifier | Defines the specific anatomical or biological region of a tissue, organ specimen, or the region from which the specimen was obtained, such as a section or part of what is defined in the OMSPEC variable. If the anatomical region is not included in the specimen description OMSPEC, it may be included in this variable. This field can be a combination of terms where needed. This field can be blank if not applicable. Examples: CORTEX, MEDULLA, MUCOSA, SEROSA, ISLET, ZONA FASICULATA, ZONA RETICULARIS, CRANIAL, MEDIAN, ACCESSORY, SPINAL, LUMBAR, FRONTAL. | Perm | |
| OMSPCCND | Specimen Condition | Char | Record Qualifier | Free or standardized text describing the condition of the specimen. Example: FIXED. | Perm | |
| OMSPCUFL | Specimen Usability for the Test | Char | (NY) | Record Qualifier | Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null. | Perm |
| OMLAT | Specimen Laterality within Subject | Char | (LAT) | Variable Qualifier | Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL. | Perm |
| OMDIR | Specimen Directionality within Subject | Char | (DIR) | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm |
| OMPORTOT | Portion or Totality | Char | (PORTOT) | Variable Qualifier | Qualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY. | Perm |
| OMEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | "Y" if the result should be excluded from all calculations, otherwise null. | Perm |
| OMREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when OMEXCLFL is "Y". | Perm | |
| OMDTC | Date/Time Organ Measured | Char | ISO 8601 datetime or interval | Timing | Date/Time of specimen/tissue weighing, in ISO 8601 format. | Exp |
| OMDY | Study Day of Measurement | Num | Timing | Study day of specimen/tissue weighing, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
| OMNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day: Used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | |
| OMNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of OMNOMDY as presented in the study report (examples: "Week 4," "Day 28," "Terminal Sac"). | Perm |
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