| Shareqc_send4tig10_ds |
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| | Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
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| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req | | DOMAIN | Domain Abbreviation | Char | MA | Identifier | Two-character code 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 | | FOCID | Focus of Study-Specific Interest | Char |
| Identifier | Identification of a focus of study-specific interest on or within a subject or specimen as defined in the protocol, for which a measurement, test, or examination was performed. An example could be a drug application site, e.g., "Injection site 1," "Biopsy site 1," "Treated site 1." the value in this variable should have inherent semantic value. | Perm | | MASEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | | MAGRPID | Group Identifier | Char |
| Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the |
treatment | dosing group number. | Perm | | MAREFID | Specimen Reference Identifier | Char |
| Identifier | Internal or external specimen identifier. Example: 1009570101. | Perm | | MASPID | Mass Identifier | Char |
| Identifier | Mass identifier such as MASS 1 or MASS A. Used when the mass was discovered during the in-life phase or during pathology and was assigned a mass identifier. The mass identification should be unique within the subject, regardless of mass location. | Perm | | MATESTCD | Macroscopic Examination Short Name | Char | (MATESTCD) | Topic | Short name of the measurement, test, or examination described in MATEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in MATESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). MATESTCD cannot contain characters other than letters, numbers, or underscores. | Req | | MATEST | Macroscopic Examination Name | Char | (MATEST) | Synonym Qualifier | Long name for MATESTCD. The value in MATEST cannot be longer than 40 characters. Extensible controlled values are Gross Pathological Examination, Clinical Signs Follow-up. | Req | | MABODSYS | Body System or Organ Class | Char | (BODSYS) | Record Qualifier | Body system or organ class associated with the specimen examined. | Perm | | MAORRES | Result or Findings as Collected | Char |
| Result Qualifier | Text description of the findings as originally received or collected, including the base gross pathological observation and any modifiers, such as severity, origin, classification, size, color, etc. | Exp | | MASTRESC | Standardized Result in Character Format | Char |
| Result Qualifier | Contains only the base gross pathological observation (e.g., ENLARGED) from MAORRES, without any modifiers. If the examination was completed and there were no findings, the value must be UNREMARKABLE. | Exp | | MASTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate examination not done or result is missing. Should be null if a result exists in MAORRES. | Perm | | MAREASND | Reason Not Done | Char |
| Record Qualifier | Describes why MASTAT is NOT DONE. Example: Tissue not examined, Tissue Autolyzed. | Perm | | MANAM | Laboratory Name | Char |
| Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm | | MASPEC | Specimen Material Type | Char | (SPEC) | Record Qualifier | Defines the type of tissue, organ, or fluid examined. Examples: GLAND, ADRENAL; KIDNEY; VESSEL, LYMPHATIC. See also Assumption 4.b. | Exp | | MAANTREG | 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 MASPEC variable. If the anatomical region is not included in the specimen description MASPEC, it may be included in this variable. This field can be a combination of terms where needed. This field can be null if not applicable. Examples: CORTEX, MEDULLA, MUCOSA, SEROSA, ISLET, ZONA FASICULATA, ZONA RETICULARIS, CRANIAL, MEDIAN, ACCESSORY, SPINAL, LUMBAR, FRONTAL. | Perm | | MASPCCND | Specimen Condition | Char |
| Record Qualifier | Free or standardized text describing the condition of the specimen. Example: AUTOLYZED. | Perm | | MASPCUFL | 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 | | MALAT | 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 | | MADIR | Specimen Directionality within Subject | Char | (DIR) | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm | | MAPORTOT | 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 | | MAEVAL | Evaluator | Char |
| Record Qualifier | Role of the person who provided the evaluation. Used only for results that are subjective (i.e., assigned by a person or a group). Examples: PRINCIPAL PATHOLOGIST, PEER REVIEW, |
SPONSOR | Applicant PATHOLOGIST. | Perm | | MASEV | Severity | Char | (SEV) | Record Qualifier | Describes the severity or intensity of a particular finding. Examples: MILD, MODERATE, SEVERE. | Perm | | MADTHREL | Relationship to Death | Char | (NY) | Record Qualifier | Describes the relationship of a particular finding to the death of a subject ("Y" |
caused | caused death, "N" = did not cause death, "U" = unknown). May be left null if not available. | Perm | | MADTC | Date/Time | Char | ISO 8601 datetime or interval | Timing | For a specimen collected or observed post mortem, this is the date/time of subject disposition in ISO 8601 format. | Perm | | MADY | Study Day | Num |
| Timing | For a specimen collected or observed post mortem, this is the study day of subject disposition, in integer days. The algorithm for calculations must be relative to the |
sponsor| applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
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