"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."
--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."
