"Variable
Name ",Variable Label ,Type ,Role ,Description
STUDYID ,Study Identifier ,Char ,Identifier ,Unique identifier for a study.
DOMAIN ,"Domain
Abbreviation",Char ,Identifier ,Two-character abbreviation for the domain which must be DM.
USUBJID ,"Unique Subject
Identifier",Char ,Identifier ,"Identifier used to uniquely identify a subject across all studies for all
applications or submissions involving the product."
SUBJID ,"Subject Identifier
for the Study",Char ,Topic ,"Subject identifier, which must be unique within the study. Often the ID
of the subject as recorded on a CRF."
RFSTDTC ,"Subject Reference
Start Date/Time",Char ,Qualifier ,"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 ,Qualifier ,"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 ,Qualifier ,"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 ,Qualifier ,"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 ,Qualifier ,Date/time of informed consent in ISO 8601 character format.
RFPENDTC ,"Date/Time of End
of Participation",Char ,Qualifier ,"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 ,Qualifier ,"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 ,Qualifier ,"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 ,Qualifier ,Unique identifier for a site within a study.
INVID ,"Investigator
Identifier",Char ,Qualifier ,"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 ,Qualifier ,Name of the investigator for a site.
BRTHDTC ,"Date/Time of
Birth",Char ,Qualifier ,Date/time of birth of the subject in ISO 8601 character format.
AGE ,Age ,Num ,Qualifier ,"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 ,Qualifier ,"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 ,Qualifier ,Units associated with AGE or AGETXT.
SEX ,Sex ,Char ,Qualifier ,Sex of the subject.
RACE ,Race ,Char ,Qualifier ,"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/ucm1
26396.pdf)."
ETHNIC ,Ethnicity ,Char ,Qualifier ,"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/ucm1
26396.pdf)."
SPECIES ,Species ,Char ,Qualifier ,"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 ,Qualifier ,"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 ,Qualifier ,"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 ,Qualifier ,"Short name for the Arm to which the subject was assigned, limited to 20
characters."
ARM ,"Description of
Planned Arm",Char ,Qualifier ,Name of the Arm to which the subject was assigned.
ACTARMCD ,Actual Arm Code ,Char ,Qualifier ,"Short name for the actual Arm in which the subject participated during
the trial, limited to 20 characters."
ACTARM ,"Description of
Actual Arm",Char ,Qualifier ,"Description of the actual Arm in which the subject participated during
the trial."
SETCD ,Set Code ,Char ,Qualifier ,"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 ,Qualifier ,"Country of the investigational site at which the subject participated in the
trial in ISO 3166 three-character format."
DMDTC ,"Date/Time of
Collection",Char ,Timing ,"Date/time of collection of the demographic information in ISO 8601
character format."
DMDY ,"Study Day of
Collection",Num ,Timing ,"Study day of collection measured as integer days. Algorithm for
calculations must be relative to the sponsor-defined RFSTDTC in
Demographics."
