"Variable
Name ",Variable Label ,Type ,Description
Identifier Variables,,,
STUDYID ,Study Identifier ,Char ,Unique identifier for a study.
DOMAIN ,"Domain
Abbreviation",Char ,Two-character abbreviation for the domain which must be DM.
USUBJID ,"Unique Subject
Identifier",Char ,"Identifier used to uniquely identify a subject across all studies for all
applications or submissions involving the product."
Topic Variables,,,
SUBJID ,"Subject Identifier
for the Study",Char ,"Subject identifier, which must be unique within the study. Often the ID of the
subject as recorded on a CRF."
Qualifier Variables,,,
RFSTDTC ,"Subject Reference
Start Date/Time",Char ,"Reference Start Date/time for the subject in ISO 8601 character format. Usually
equivalent to date/time when subject was first exposed to study treatment.
Required for all randomized subjects; will be null for all subjects who did not
meet the milestone the date requires, such as screen failures or unassigned
subjects."
RFENDTC ,"Subject Reference
End Date/Time",Char ,"Reference End Date/time for the subject in ISO 8601 character format. Usually
equivalent to the date/time when subject was determined to have ended the
trial, and often equivalent to date/time of last exposure to study treatment.
Required for all randomized subjects; null for screen failures or unassigned
subjects."
RFXSTDTC ,"Date/Time of First
Study Treatment",Char ,"First date/time of exposure to any protocol-specified treatment or therapy for
the subject in ISO 8601 character format."
RFXENDTC ,"Date/Time of Last
Study Treatment",Char ,"Last date/time of exposure to any protocol-specified treatment or therapy for
the subject in ISO 8601 character format."
RFICDTC ,"Date/Time of
Informed Consent",Char ,Date/time of informed consent in ISO 8601 character format.
RFPENDTC ,"Date/Time of End
of Participation",Char ,"Date/time when subject ended participation or follow-up in a trial, in ISO 8601
character format. Should correspond to the last known date of contact."
DTHDTC ,Date/Time of Death ,Char ,"Date/time of death for any subject who died, in ISO 8601 format. Should
represent the date/time that is captured in the clinical-trial database."
DTHFL ,Subject Death Flag ,Char ,"A value of ‘Y’ indicates the subject died. Should be Y or null. Should be
populated even when the death date is unknown."
SITEID ,"Study Site
Identifier",Char ,Unique identifier for a site within a study.
INVID ,"Investigator
Identifier",Char ,"An identifier to describe the Investigator for the study. May be used in addition
to the SITEID. Not needed if SITEID is equivalent to INVID."
INVNAM ,Investigator Name ,Char ,Unique identifier for a site within a study.
BRTHDTC ,Date/Time of Birth ,Char ,Date/time of birth of the subject in ISO 8601 character format.
AGE ,Age ,Num ,"Age expressed in AGEU. May be derived as (RFSTDTC-BRTHDTC), but
BRTHDTC may not be available in all cases (due to subject privacy concerns)."
AGETXT ,Age Text ,Char ,"The age of the subject at study start, as planned, expressed as a range. If an age
integer value is available, then populate the age variable instead. Either the
AGE or AGETXT variable should be populated, but not both."
AGEU ,Age Units ,Char ,Units associated with AGE or AGETXT.
SEX ,Sex ,Char ,Sex of the subject.
RACE ,Race ,Char ,"Race of the subject. Sponsors should refer to “Collection of Race and Ethnicity
Data in Clinical Trials” (FDA, September 2005) for guidance regarding the
collection of race
(http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126396.
pdf)"
ETHNIC ,Ethnicity ,Char ,"The ethnicity of the subject. Sponsors should refer to “Collection of Race and
Ethnicity Data in Clinical Trials” (FDA, September 2005) for guidance
regarding the collection of ethnicity
(http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126396.
pdf)"
SPECIES ,Species ,Char ,"Used to identify the common species name of the subject (i.e., test system)
under study (e.g., MOUSE, RAT, DOG, MONKEY)."
STRAIN ,Strain/Substrain ,Char ,"Used to identify the vendor-supplied strain/substrain designation for the subject
(i.e., test system) under study. When applicable, it combines the root strain,
substrain, and associated genetic modifications, as supplied by the vendor (e.g.,
C57BL/6, A/J, B6.129-Pparg<tm2Rev>/J, FISCHER 344, SPRAGUE
DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS,
CHIMPANZEE)."
SBSTRAIN ,"Strain/Substrain
Details",Char ,"Free-text field that allows the sponsor to enter additional details regarding the
subject (i.e. test system) under study, such as a description of a specific genetic
alteration."
ARMCD ,Planned Arm Code ,Char ,"Short name for the Arm to which the subject was assigned, limited to 20
characters."
ARM ,"Description of
Planned Arm",Char ,Name of the Arm to which the subject was assigned.
ACTARMCD ,Actual Arm Code ,Char ,"Short name for the actual Arm in which the subject participated during the trial,
limited to 20 characters."
ACTARM ,"Description of
Actual Arm",Char ,Description of the actual Arm in which the subject participated during the trial.
SETCD ,Set Code ,Char ,"Short name of a specific Trial Set (see Table 3.2.4), as defined by the sponsor.
Maximum of 8 characters. This represents the code for the Trial Set for which
parameters are being submitted."
COUNTRY ,Country ,Char ,"Country of the investigational site at which the subject participated in the trial
in ISO 3166 three-character format."
Timing Variables,,,
DMDTC ,"Date/Time of
Collection",Char ,"Date/time of collection of the demographic information in ISO 8601 character
format."
DMDY ,"Study Day of
Collection",Num ,"Study day of collection measured as integer days. Algorithm for calculations
must be relative to the sponsor-defined RFSTDTC in Demographics."
