| 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 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 |
| 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 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 |