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Comment: TOBA-544
Metadataspec
Notes;Core;Description
highlighttruekeys
Shareqc_send4tig10_ds
ClassFindings
DomainMA
Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharMAIdentifierTwo-character code 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
MASEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
MAGRPIDGroup IdentifierChar
IdentifierUsed to tie together a block of related records in a single domain for a subject. This is not the
treatment
dosing group number.Perm
MAREFIDSpecimen Reference IdentifierChar
IdentifierInternal or external specimen identifier. Example: 1009570101.Perm
MASPIDMass 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
MATESTCDMacroscopic Examination Short NameChar(MATESTCD)TopicShort 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
MATESTMacroscopic Examination NameChar(MATEST)Synonym QualifierLong 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
MABODSYSBody System or Organ ClassChar(BODSYS)Record QualifierBody system or organ class associated with the specimen examined.Perm
MAORRESResult or Findings as CollectedChar
Result QualifierText 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
MASTRESCStandardized Result in Character FormatChar
Result QualifierContains 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
MASTATCompletion StatusChar(ND)Record QualifierUsed to indicate examination not done or result is missing. Should be null if a result exists in MAORRES.Perm
MAREASNDReason Not DoneChar
Record QualifierDescribes why MASTAT is NOT DONE. Example: Tissue not examined, Tissue Autolyzed.Perm
MANAMLaboratory NameChar
Record QualifierName or identifier of the laboratory or vendor that provided the test results.Perm
MASPECSpecimen Material TypeChar(SPEC)Record QualifierDefines the type of tissue, organ, or fluid examined. Examples: GLAND, ADRENAL; KIDNEY; VESSEL, LYMPHATIC. See also Assumption 4.b.Exp
MAANTREGAnatomical Region of SpecimenChar
Variable QualifierDefines 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
MASPCCNDSpecimen ConditionChar
Record QualifierFree or standardized text describing the condition of the specimen. Example: AUTOLYZED.Perm
MASPCUFLSpecimen 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.Perm
MALATSpecimen Laterality within SubjectChar(LAT)Variable QualifierQualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL.Perm
MADIRSpecimen Directionality within SubjectChar(DIR)Variable QualifierQualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL.Perm
MAPORTOTPortion or TotalityChar(PORTOT)Variable QualifierQualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY.Perm
MAEVALEvaluatorChar
Record QualifierRole 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
MASEVSeverityChar(SEV)Record QualifierDescribes the severity or intensity of a particular finding. Examples: MILD, MODERATE, SEVERE.Perm
MADTHRELRelationship to DeathChar(NY)Record QualifierDescribes 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
MADTCDate/TimeCharISO 8601 datetime or intervalTimingFor a specimen collected or observed post mortem, this is the date/time of subject disposition in ISO 8601 format.Perm
MADYStudy 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
applicant-defined RFSTDTC variable in the Demographics (DM) domain.Perm