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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 NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharMIIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.Req
FOCIDFocus of Study-Specific InterestChar
IdentifierIdentification 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
MISEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
MIGRPIDGroup IdentifierChar
IdentifierUsed to tie together a block of related records in a single domain for a subject. This is not the treatment group number.Perm
MIREFIDSpecimen Reference IdentifierChar
IdentifierInternal or external specimen identifier. Example: Specimen barcode number.Perm
MISPIDMass IdentifierChar
IdentifierMass 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
MITESTCDMicroscopic Examination Short NameChar(MITESTCD)TopicShort 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
MITESTMicroscopic Examination NameChar(MITEST)Synonym QualifierLong name for MITESTCD. The value in MITEST cannot be longer than 40 characters. Extensible controlled value is Microscopic Examination.Req
MIBODSYSBody System or Organ ClassChar(BODSYS)Record QualifierBody system or organ class associated with the specimen examined.Perm
MIORRESResult or Findings as CollectedChar
Result QualifierMicroscopic finding as originally recorded, including all modifiers.Exp
MISTRESCStandardized Result in Character FormatChar(NONNEO)
(NEOPLASM)
Result QualifierFor 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
MIRESCATResult CategoryChar(MIRESCAT)Variable QualifierUsed to categorize the result of a finding. Example: MALIGNANT for tumor findings or NON-NEOPLASTIC for pathology findings.Perm
MICHRONChronicity of FindingChar(CHRNCTY)Variable QualifierDescribes the apparent relative duration of a particular finding. Examples: ACUTE, CHRONIC.Exp
MIDISTRDistribution Pattern of FindingChar(DSTRBN)Variable QualifierDistribution pattern of a particular finding(s) within the examined area. Examples: DIFFUSE, FOCAL, MULTIFOCAL.Exp
MISTATCompletion StatusChar(ND)Record QualifierUsed 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
MIREASNDReason Not DoneChar
Record QualifierDescribes why MISTAT is NOT DONE, such as SAMPLE AUTOLYZED or SPECIMEN LOST.Perm
MINAMLaboratory NameChar
Record QualifierName or identifier of the laboratory or vendor that provided the test results.Perm
MISPECSpecimen Material TypeChar(SPEC)Record QualifierDefines the type of tissue, orgain, or fluid specimen examined. Examples: LIVER, HEART, BONE MARROW.Req
MIANTREGAnatomical Region of SpecimenChar
Variable QualifierThe protocol-defined subregion of the specimen examined. Example: Cortex or Medulla (if the MISPEC is, for example, GLAND, ADRENAL).Perm
MISPCCNDSpecimen ConditionChar
Record QualifierFree or standardized text describing the condition of the specimen. Example: AUTOLYZED.Exp
MISPCUFLSpecimen Usability for the TestChar(NY)Record QualifierDescribes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null.Exp
MILATSpecimen Laterality within SubjectChar(LAT)Variable QualifierQualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL.Perm
MIDIRSpecimen Directionality within SubjectChar(DIR)Variable QualifierQualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL.Perm
MIMETHODMethod of Test or ExaminationChar
Record QualifierMethod of the test or examination. This could be different types of staining used for the slides whenever appropriate. Example: H&E.Perm
MIEVALEvaluatorChar
Record QualifierRole of the person who provided the evaluation. Examples: TOX PATHOLOGIST, PEER REVIEW, SPONSOR PATHOLOGIST.Perm
MISEVSeverityChar(SEV)Record QualifierDescribes the severity of a particular finding.Exp
MIDTHRELRelationship to DeathChar(NY)Record QualifierDescribes 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
MIDTCDate/TimeCharISO 8601TimingFor a specimen collected or observed post mortem, this is the date/time of subject disposition, in ISO 8601 format.Perm
MIDYStudy DayNum
TimingFor 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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