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| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | 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 | 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 | 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 | 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 | 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 | Identifier | Used to tie together a block of related records in a single domain for a subject or pool. This is not the product exposure group number. | Perm | |
| CLSPID | Mass Identifier | Char | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | Record Qualifier | Describes why CLSTAT is NOT DONE, such as SUBJECT MORIBUND. | Perm | |
| CLLOC | Location of a Finding | Char | Record Qualifier | Can be used to specify where a clinical sign occurred. Example: LEFT EAR for skin rash. | Exp | |
| CLEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Example: TOX TECHNICIAN, OPHTHALMOLOGIST, VETERINARIAN. | Perm | |
| CLSEV | Severity | Char | 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 | 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 | Timing | Planned study day of collection. Should be an integer. | Perm | |
| CLDTC | Date/Time of Observation | Char | ISO 8601 | 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 | 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 | 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 applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
| CLENDY | Study Day of End of Observation | Num | 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 applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
| CLNOMDY | Nominal Study Day for Tabulations | Num | 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 | 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 | 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 | Timing | Numerical version of CLTPT to aid in sorting. | Perm | |
| CLELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 | 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 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 | 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 | Timing | Date/Time of the reference time point, CLTPTREF. | Perm |
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