Variable Name,Variable Label,Type,Role,Description
Topic Variable,,,,
--TRT,Name of Treatment,Char,Topic,"The topic for the intervention observation, usually the verbatim name of the treatment, drug, medicine, or therapy given during the dosing interval for the observation."
Qualifier Variables,,,,
--MODIFY,Modified Treatment Name,Char,Synonym Qualifier of --TRT,"If the value for --TRT is modified for coding purposes, then the modified text is placed here."
--DECOD,Standardized Treatment Name,Char,Synonym Qualifier of --TRT,"Standardized or dictionary-derived name of the topic variable, --TRT, or the modified topic variable (--MODIFY), if applicable. Equivalent to the generic drug name in WHO Drug, or a term in SNOMED, ICD9, or other published or sponsor-defined dictionaries."
--MOOD,Mood,Char,Record Qualifier,"Mode or condition of the record (e.g., ""SCHEDULED"", ""PERFORMED"")."
--CAT,Category,Char,Grouping Qualifier,Used to define a category of topic-variable values.
--SCAT,Subcategory,Char,Grouping Qualifier,Used to define a further categorization of --CAT values.
--PRESP,Pre-specified,Char,Variable Qualifier of --TRT,"Used when a specific intervention is pre-specified on a CRF. Values should be ""Y"" or null."
--OCCUR,Occurrence Indicator,Char,Record Qualifier,Used to record whether a pre-specified intervention occurred when information about the occurrence of a specific intervention is solicited.
--STAT,Completion Status,Char,Record Qualifier,Used to indicate when a question about the occurrence of a pre-specified intervention was not answered. Should be null or have a value of NOT DONE.
--REASND,Reason Not Done,Char,Record Qualifier,"Reason not done. Used in conjunction with --STAT when value is ""NOT DONE""."
--INDC,Indication,Char,Record Qualifier,"Denotes the indication for the intervention (e.g., why the therapy was taken or administered)."
--CLAS,Class,Char,Variable Qualifier of --TRT,"Class for a medication or treatment, often obtained from a coding dictionary."
--CLASCD,Class Code,Char,Variable Qualifier of --TRT,Used to represent code for --CLAS.
--DOSE,Dose,Num,Record Qualifier,Amount of --TRT given. Not populated when --DOSTXT is populated.
--DOSTXT,Dose Description,Char,Record Qualifier,"Dosing information collected in text form. Examples: <1 per day, 200-400. Not populated when --DOSE is populated."
--DOSU,Dose Units,Char,"Variable Qualifier of --DOSE, --DOSTXT or --DOSTOT","Units for --DOSE, --DOSTOT, or --DOSTXT. Examples: ""ng"", ""mg"", ""mg/kg""."
--DOSFRM,Dose Form,Char,"Variable Qualifier of --DOSE, --DOSTXT or --DOSTOT","Dose form for the treatment. Examples: ""TABLET"", ""CAPSULE""."
--DOSFRQ,Dosing Frequency per Interval,Char,"Variable Qualifier of --DOSE, --DOSTXT or --DOSTOT","Usually expressed as the number of doses given per a specific interval. Examples: ""Q2H"", ""QD"", ""PRN""."
--DOSTOT,Total Daily Dose,Num,Record Qualifier,Total daily dose of --TRT using the units in --DOSU. Used when dosing is collected as Total Daily Dose.
--DOSRGM,Intended Dose Regimen,Char,"Variable Qualifier of --DOSE, --DOSTXT or --DOSTOT","Text description of the (intended) schedule or regimen for the Intervention. Example: ""TWO WEEKS ON, TWO WEEKS OFF""."
--ROUTE,Route of Administration,Char,Variable Qualifier of --TRT,"Route of administration for the intervention. Examples: ""ORAL"", ""INTRAVENOUS""."
--LOT,Lot Number,Char,Record Qualifier,Lot number for the intervention described in --TRT.
--LOC,Location of Dose Administration,Char,Record Qualifier,"Anatomical location of an intervention, such as an injection site. Example: ARM for an injection."
--LAT,Laterality,Char,Variable Qualifier of --LOC,"Qualifier for anatomical location further detailing laterality of intervention administration. Examples: ""RIGHT"", ""LEFT"", ""BILATERAL""."
--DIR,Directionality,Char,Variable Qualifier of --LOC,"Qualifier for anatomical location further detailing directionality of intervention administration. Examples: ""ANTERIOR"", ""LOWER"", ""PROXIMAL""."
--PORTOT,Portion or Totality,Char,Variable Qualifier of --LOC,"Qualifier for anatomical location further detailing the distribution, which means arrangement of, apportioning of the intervention administration. Examples: ""ENTIRE"", ""SINGLE"", ""SEGMENT"", ""MANY""."
--FAST,Fasting Status,Char,Record Qualifier,"Indicator used to identify fasting status. Valid values include ""Y"", ""N"", ""U"" or null if not relevant."
--PSTRG,Pharmaceutical Strength,Num,Record Qualifier,"Amount of an active ingredient expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form. Example: ""50 mg/TABLET"", ""300 mg/L""."
--PSTRGU,Pharmaceutical Strength Units,Char,Variable Qualifier of --PSTRG,"Unit for --PSTRG. Example: ""mg/TABLET"", ""mg/m""L."
--TRTV,Treatment Vehicle,Char,Record Qualifier,"Vehicle for administration of treatment, such as a liquid in which the treatment drug is dissolved. Example: ""SALINE""."
--VAMT,Treatment Vehicle Amount,Num,Record Qualifier,Amount of the prepared product (treatment + vehicle) administered or given. Note: should not be diluent amount alone.
--VAMTU,Treatment Vehicle Amount Units,Char,Variable Qualifier of --VAMT,"Units for the prepared product (treatment + vehicle). Examples: ""mL"", ""mg""."
--ADJ,Reason for Dose Adjustment,Char,Record Qualifier,"Describes reason or explanation of why a dose is adjusted. Examples ""ADVERSE EVENT"", ""INSUFFICIENT RESPONSE"", ""NON-MEDICAL REASON""."
--RSDISC,Reason for Treatment Discontinuation,Char,Record Qualifier,Reason why the treatment was discontinued.
--USCHFL,Unscheduled Flag,Char,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. Not to be used with human clinical trials. This variable would not be needed when information on planned assessments is provided, such as when the Trial Visits (TV) and Subject Visits (SV) domains are used."
