Variable Name,Variable Label,Type,Format,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,ISO 8601,Qualifier,"Reference Start Date/time for the subject. 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,ISO 8601,Qualifier,"Reference End Date/time for the subject. 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,ISO 8601,Qualifier,First date/time of exposure to any protocol-specified treatment or therapy for the subject.
RFXENDTC,Date/Time of Last Study Treatment,Char,ISO 8601,Qualifier,Last date/time of exposure to any protocol-specified treatment or therapy for the subject.
RFICDTC,Date/Time of Informed Consent,Char,ISO 8601,Qualifier,Date/time of informed consent.
RFPENDTC,Date/Time of End of Participation,Char,ISO 8601,Qualifier,Date/time when subject ended participation or follow-up in a trial. Should correspond to the last known date of contact.
DTHDTC,Date/Time of Death,Char,ISO 8601,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,ISO 8601,Qualifier,Date/time of birth of the subject.
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,number-number,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, October 2016) for guidance regarding the collection of race (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126396.pdf)"
ETHNIC,Ethnicity,Char,,Qualifier,"The ethnicity of the subject. Sponsors should refer to ""Collection of Race and Ethnicity Data in Clinical Trials"" (FDA, October 2016) for guidance regarding the collection of ethnicity (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126396.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 3.1.4), as defined by the sponsor. Maximum of 8 characters. This represents the code for the Trial Set for which parameters are being submitted."
RPATHCD,Planned Repro Path Code,Char,,Qualifier,Short name for the planned Repro Path to which the subject was assigned. Limited to 20 characters. Not to be used with human clinical trials.
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,ISO 8601,Timing,Date/time of collection of the demographic information.
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.
