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TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1
Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. 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 | MI | 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 | |
| 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 | |
| MISEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
| MIGRPID | 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 group number. | Perm | |
| MIREFID | Specimen Reference Identifier | Char | Identifier | Internal or external specimen identifier. Example: Specimen barcode number. | Perm | |
| MISPID | 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 | |
| MITESTCD | Microscopic Examination Short Name | Char | (MITESTCD) | Topic | Short name of the measurement, test, or examination described in MITEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in MITESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). MITESTCD cannot contain characters other than letters, numbers, or underscores. Extensible controlled value is MIEXAM covering an assessment by microscope (e.g., light, elctron, confocal, etc). | Req |
| MITEST | Microscopic Examination Name | Char | (MITEST) | Synonym Qualifier | Long name for MITESTCD. The value in MITEST cannot be longer than 40 characters. Extensible controlled value is Microscopic Examination. | Req |
| MIBODSYS | Body System or Organ Class | Char | (BODSYS) | Record Qualifier | Body system or organ class associated with the specimen examined. | Perm |
| MIORRES | Result or Findings as Collected | Char | Result Qualifier | Microscopic finding as originally recorded, including all modifiers. | Exp | |
| MISTRESC | Standardized Result in Character Format | Char | (NONNEO) (NEOPLASM) | Result Qualifier | For non-neoplastic findings, contains only the base pathological process (e.g., NECROSIS) without any modifiers such as severity, distribution, chronicity or characteristics. If the examination was completed and there were no findings, the value must be UNREMARKABLE. The base pathological process from MIORRES should be mapped to a synonymous term from the controlled list, NONNEO, where possible. Neoplastic findings must be populated using the NEOPLASM controlled list. | Exp |
| MIRESCAT | Result Category | Char | (MIRESCAT) | Variable Qualifier | Used to categorize the result of a finding. Example: MALIGNANT for tumor findings or NON-NEOPLASTIC for pathology findings. | Perm |
| MICHRON | Chronicity of Finding | Char | (CHRNCTY) | Variable Qualifier | Describes the apparent relative duration of a particular finding. Examples: ACUTE, CHRONIC. | Exp |
| MIDISTR | Distribution Pattern of Finding | Char | (DSTRBN) | Variable Qualifier | Distribution pattern of a particular finding(s) within the examined area. Examples: DIFFUSE, FOCAL, MULTIFOCAL. | Exp |
| MISTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate a test was not done or a test was attempted but did not generate a result. Should be null or have a value of NOT DONE. | Perm |
| MIREASND | Reason Not Done | Char | Record Qualifier | Describes why MISTAT is NOT DONE, such as SAMPLE AUTOLYZED or SPECIMEN LOST. | Perm | |
| MINAM | Laboratory Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm | |
| MISPEC | Specimen Material Type | Char | (SPEC) | Record Qualifier | Defines the type of tissue, orgain, or fluid specimen examined. Examples: LIVER, HEART, BONE MARROW. | Req |
| MIANTREG | Anatomical Region of Specimen | Char | Variable Qualifier | The protocol-defined subregion of the specimen examined. Example: Cortex or Medulla (if the MISPEC is, for example, GLAND, ADRENAL). | Perm | |
| MISPCCND | Specimen Condition | Char | Record Qualifier | Free or standardized text describing the condition of the specimen. Example: AUTOLYZED. | Exp | |
| MISPCUFL | 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. | Exp |
| MILAT | 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 |
| MIDIR | Specimen Directionality within Subject | Char | (DIR) | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm |
| MIMETHOD | Method of Test or Examination | Char | Record Qualifier | Method of the test or examination. This could be different types of staining used for the slides whenever appropriate. Example: H&E. | Perm | |
| MIEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Examples: TOX PATHOLOGIST, PEER REVIEW, SPONSOR PATHOLOGIST. | Perm | |
| MISEV | Severity | Char | (SEV) | Record Qualifier | Describes the severity of a particular finding. | Exp |
| MIDTHREL | Relationship to Death | Char | (NY) | Record Qualifier | Describes the relationship of a particular finding to the death of a subject ("Y" = caused death, "N" = did not cause death, "U" = unknown). May be left null if not available. | Perm |
| MIDTC | Date/Time | Char | ISO 8601 | Timing | For a specimen collected or observed post mortem, this is the date/time of subject disposition, in ISO 8601 format. | Perm |
| MIDY | 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-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
Metadata Checks Findings
SDTM & Related IG Metadata Check User Macros FAQ
- Content: For variable MITESTCD, non-ASCII characters (highlighted text in table), found in CDISC Notes; offending characters list: [ , ]
- Content: For variable MITEST, non-ASCII characters (highlighted text in table), found in CDISC Notes; offending characters list: [ ]
- Content: For variable MIDTHREL, non-ASCII characters (highlighted text in table), found in CDISC Notes; offending characters list: [ , ]
- Content: For variable MIDTC, ISO 8601 is a not a recognized content for Controlled Terms, Codelist, or Format
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