"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 ,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 ,"Variable
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","Unit for --PSTRG. Example: mg/TABLET, mg/mL"
--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."
