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Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharCLIdentifierTwo-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. Either USUBJID or POOLID must be populated.Exp
POOLIDPool IdentifierChar
IdentifierIdentifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated.Perm
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
CLSEQSequence NumberNum
IdentifierThe sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record.Req
CLGRPIDGroup IdentifierChar
IdentifierUsed to tie together a block of related records in a single domain for a subject or pool. This is not the treatment group number.Perm
CLSPIDMass IdentifierChar
IdentifierMass identifier such as MASS 1 or MASS A. Used when the mass was discovered during the in-life phase and assigned a mass identifier. The mass identification should be unique within the subject, regardless of mass location.Perm
CLTESTCDTest Short NameChar
TopicShort name of the measurement, test, or examination described in CLTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in CLTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). CLTESTCD cannot contain characters other than letters, numbers, or underscores.Req
CLTESTTest NameChar
Synonym QualifierLong name for CLTESTCD. The value in CLTEST cannot be longer than 40 characters.Req
CLCATCategory for Clinical ObservationsChar(CLCAT)Grouping QualifierUsed to define a category of the clinical observation.Req
CLSCATSubcategory for Clinical ObservationsChar
Grouping QualifierUsed to further categorize a group of clinical observations within a category. For example "Whole Body Appearance" and "Sensory Organ Appearance" may be subcategories within Clinical Signs.Perm
CLBODSYSBody System or Organ ClassChar(BODSYS)Record QualifierBody system or organ class associated with the measurement performed.Perm
CLORRESResult or Findings as CollectedChar
Result QualifierText description of the finding as originally received or collected. If the examination was not performed on a particular body system, or at the subject level, then the value should be null, and NOT DONE should appear in CLSTAT.Exp
CLSTRESCStandardized Result in Character FormatChar
Result QualifierThe base finding from CLORRES without modifiers. If the examination was completed and there were no abnormal findings, the value must be NORMAL.Exp
CLRESCATResult CategoryChar
Variable QualifierUsed to categorize the result of a finding post collection. Examples: Color or Facial.Perm
CLSTATCompletion StatusChar(ND)Record QualifierUsed to indicate examination not done or result is missing. Should be null if a result exists in CLORRES.Perm
CLREASNDReason Not DoneChar
Record QualifierDescribes why CLSTAT is NOT DONE, such as SUBJECT MORIBUND.Perm
CLLOCLocation of a FindingChar
Record QualifierCan be used to specify where a clinical sign occurred. Example: LEFT EAR for skin rash.Exp
CLEVALEvaluatorChar
Record QualifierRole of the person who provided the evaluation. Example: TOX TECHNICIAN, OPHTHALMOLOGIST, VETERINARIAN.Perm
CLSEVSeverityChar
Record QualifierDescribes the severity or intensity of a particular finding.Perm
CLEXCLFLExclusion FlagChar(NY)Record QualifierY if the result should be excluded from all calculations, otherwise null.Perm
CLREASEXReason for ExclusionChar
Record QualifierThe reason the result should be excluded from all calculations. Used only when CLEXCLFL is Y.Perm
CLUSCHFLUnscheduled FlagChar(NY)Record QualifierIndicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null.Perm
VISITDYPlanned Study Day of CollectionNum
TimingPlanned study day of collection. Should be an integer.Perm
CLDTCDate/Time of ObservationCharISO 8601TimingDate/Time of the clinical observation in ISO 8601 format. For measurements related to a continuous evaluation interval, CLDTC should be used to indicate the start date/time of that interval.Exp
CLENDTCEnd Date/Time of ObservationCharISO 8601TimingDate/Time of end of observation interval, in ISO 8601 format. Should be populated when CLDTC represents the start date/time of a continuous evaluation interval.Perm
CLDYStudy Day of ObservationNum
TimingStudy day of observation, in integer days. For measurements related to a continuous evaluation interval, CLDY can be used to indicate start day of that interval. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.Perm
CLENDYStudy Day of End of ObservationNum
TimingStudy day of the end of observation, in integer days. Can be populated when CLDY represents the start day of a continuous evaluation interval. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.Perm
CLNOMDYNominal 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
CLNOMLBLLabel for Nominal Study DayChar
TimingA label for a given value of CLNOMDY as presented in the study report. Examples: "Week 4," "Day 28," "Terminal Sac".Perm
CLTPTPlanned Time Point NameChar
TimingText description of time when an observation should be taken, as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time postdose.Perm
CLTPTNUMPlanned Time Point NumberNum
TimingNumerical version of CLTPT to aid in sorting.Perm
CLELTMPlanned Elapsed Time from Time Point RefCharISO 8601TimingPlanned Elapsed time (in ISO 8601 format) relative to a planned reference (CLTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "- PT15M" to represent the period of 15 minutes prior to the reference point indicated by CLTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by CLTPTREF.Perm
CLTPTREFTime Point ReferenceChar
TimingName of the fixed reference point referred to by CLELTM, if used for CLTPTNUM, and CLTPT. It is recommended that CLTPTREF be as descriptive as possible, so the reference time point can be inferred without looking at other variables. Examples: PREVIOUS DOSE, PREVIOUS MEAL.Perm
CLRFTDTCDate/Time of Reference Time PointCharISO 8601TimingDate/Time of the reference time point, CLTPTREF.Perm

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