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Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharOMIdentifierTwo-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
OMSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
OMTESTCDTest Short NameChar(OMTESTCD)TopicShort 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
OMTESTTest NameChar(OMTEST)Synonym QualifierLong name for OMTESTCD. The value in OMTEST cannot be longer than 40 characters.Req
OMORRESResult or Findings as CollectedChar
Result QualifierResult of the measurement or finding as originally received or collected.Exp
OMORRESUUnit of the Original ResultChar(UNIT)Variable QualifierThe unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list.Exp
OMSTRESCStandardized Result in Character FormatChar
Result QualifierContains 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
OMSTRESNStandardized Result in Numeric FormatNum
Result QualifierUsed for numeric results or findings in standard format; contains the numeric form of OMSTRESC. OMSTRESN should store all numeric test results or findings.Exp
OMSTRESUUnit of the Standardized ResultChar(UNIT)Variable QualifierStandardized unit used for OMSTRESC and OMSTRESN.Exp
OMSTATCompletion StatusChar(ND)Record QualifierUsed to indicate when a test is not done or result is missing. Should be null if a result exists in OMORRES.Perm
OMREASNDReason Not DoneChar
Record QualifierDescribes why OMSTAT is NOT DONE, such as BROKEN EQUIPMENT or TECHNICIAN OVERSIGHT.Perm
OMSPECSpecimen Material TypeChar(SPEC)Record QualifierDefines the type of tissue, organ, or fluid specimen used as the object for the finding. Examples: GLAND, ADRENAL, KIDNEY, VESSEL, LYMPHATIC.Req
OMANTREGAnatomical 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 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
OMSPCCNDSpecimen ConditionChar
Record QualifierFree or standardized text describing the condition of the specimen. Example: FIXED.Perm
OMSPCUFLSpecimen 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
OMLATSpecimen Laterality within SubjectChar(LAT)Variable QualifierQualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL.Perm
OMDIRSpecimen Directionality within SubjectChar(DIR)Variable QualifierQualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL.Perm
OMPORTOTPortion 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
OMEXCLFLExclusion FlagChar(NY)Record Qualifier"Y" if the result should be excluded from all calculations, otherwise null.Perm
OMREASEXReason for ExclusionChar
Record QualifierThe reason the result should be excluded from all calculations. Used only when OMEXCLFL is "Y".Perm
OMDTCDate/Time Organ MeasuredCharISO 8601TimingDate/Time of specimen/tissue weighing, in ISO 8601 format.Exp
OMDYStudy Day of MeasurementNum
TimingStudy 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
OMNOMDYNominal Study Day for TabulationsNum
TimingNominal 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
OMNOMLBLLabel for Nominal Study DayChar
TimingA 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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