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Shareqc_send4tig10_ds

Class	Findings
Domain	CL

Variable Name	Variable Label	Type

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Controlled Terms, Codelist, or Format	Role	CDISC Notes	Core
STUDYID	Study Identifier	Char

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		Identifier	Unique identifier for a study.	Req
DOMAIN	Domain Abbreviation	Char	CL	Identifier	Two-character abbreviation for the domain.	Req
USUBJID	Unique Subject Identifier	Char

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		Identifier	Identifier 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
POOLID	Pool Identifier	Char

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		Identifier	Identifier 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
FOCID	Focus of Study-Specific Interest	Char

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		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
CLSEQ	Sequence Number	Num

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		Identifier	The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record.	Req
CLGRPID	Group Identifier	Char

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Identifier

Used to tie together a block of related records in a single domain for a subject or pool. This is not the

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product exposure group number.	Perm
CLSPID	Mass Identifier	Char

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		Identifier	Mass 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
CLTESTCD	Test Short Name	Char

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Topic

Short 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

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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
CLTEST	Test Name	Char

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		Synonym Qualifier	Long name for CLTESTCD. The value in CLTEST cannot be longer than 40 characters.	Req
CLCAT	Category for Clinical Observations	Char	(CLCAT)	Grouping Qualifier	Used to define a category of the clinical observation.	Req
CLSCAT	Subcategory for Clinical Observations	Char

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		Grouping Qualifier	Used 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
CLBODSYS	Body System or Organ Class	Char	(BODSYS)	Record Qualifier	Body system or organ class associated with the measurement performed.	Perm
CLORRES	Result or Findings as Collected	Char

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		Result Qualifier	Text 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
CLSTRESC	Standardized Result in Character Format	Char

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		Result Qualifier	The base finding from CLORRES without modifiers. If the examination was completed and there were no abnormal findings, the value must be NORMAL.	Exp
CLRESCAT	Result Category	Char

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		Variable Qualifier	Used to categorize the result of a finding post collection. Examples: Color or Facial.	Perm
CLSTAT	Completion Status	Char	(ND)	Record Qualifier	Used to indicate examination not done or result is missing. Should be null if a result exists in CLORRES.	Perm
CLREASND	Reason Not Done	Char

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		Record Qualifier	Describes why CLSTAT is NOT DONE, such as SUBJECT MORIBUND.	Perm
CLLOC	Location of a Finding	Char

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		Record Qualifier	Can be used to specify where a clinical sign occurred. Example: LEFT EAR for skin rash.	Exp
CLEVAL	Evaluator	Char

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		Record Qualifier	Role of the person who provided the evaluation. Example: TOX TECHNICIAN, OPHTHALMOLOGIST, VETERINARIAN.	Perm
CLSEV	Severity	Char

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		Record Qualifier	Describes the severity or intensity of a particular finding.	Perm
CLEXCLFL	Exclusion Flag	Char	(NY)	Record Qualifier	Y if the result should be excluded from all calculations, otherwise null.	Perm
CLREASEX	Reason for Exclusion	Char

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		Record Qualifier	The reason the result should be excluded from all calculations. Used only when CLEXCLFL is Y.	Perm
CLUSCHFL	Unscheduled Flag	Char	(NY)	Record Qualifier	Indicates 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
VISITDY	Planned Study Day of Collection	Num

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		Timing	Planned study day of collection. Should be an integer.	Perm
CLDTC	Date/Time of Observation	Char	ISO 8601 datetime or interval	Timing	Date/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
CLENDTC	End Date/Time of Observation	Char	ISO 8601 datetime or interval	Timing	Date/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
CLDY	Study Day of Observation	Num

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Timing

Study 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

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applicant-defined RFSTDTC variable in the Demographics (DM) domain.	Perm
CLENDY	Study Day of End of Observation	Num

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Timing

Study 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

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applicant-defined RFSTDTC variable in the Demographics (DM) domain.	Perm
CLNOMDY	Nominal Study Day for Tabulations	Num

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		Timing	Nominal 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
CLNOMLBL	Label for Nominal Study Day	Char

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		Timing	A label for a given value of CLNOMDY as presented in the study report. Examples: "Week 4," "Day 28," "Terminal Sac".	Perm
CLTPT	Planned Time Point Name	Char

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		Timing	Text 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
CLTPTNUM	Planned Time Point Number	Num

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		Timing	Numerical version of CLTPT to aid in sorting.	Perm
CLELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601 duration	Timing	Planned 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

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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
CLTPTREF	Time Point Reference	Char

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		Timing	Name 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
CLRFTDTC	Date/Time of Reference Time Point	Char	ISO 8601 datetime or interval	Timing	Date/Time of the reference time point, CLTPTREF.	Perm

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