Variable Name,Variable Label,Type,Format,Role,Description
STUDYID,Study Identifier,Char,,Identifier,Unique identifier for a study.
DOMAIN,Domain Abbreviation,Char,,Identifier,"2-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,Record Qualifier,"Reference start date or start date and 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,Record 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,Record 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,Record 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,Record Qualifier,Date/time of informed consent.
RFPENDTC,Date/Time of End of Participation,Char,ISO 8601,Record 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,Record 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,,Record 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,,Record Qualifier,Unique identifier for a site within a study.
INVID,Investigator Identifier,Char,,Record 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,,Synonym Qualifier of INVID,Name of the investigator for a site.
BRTHDTC,Date/Time of Birth,Char,ISO 8601,Record Qualifier,Date/time of birth of the subject.
AGE,Age,Num,,Record 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,Record 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,,Variable Qualifier of AGE or AGETXT,Units associated with AGE or AGETXT.
SEX,Sex,Char,,Record Qualifier,Sex of the subject.
RACE,Race,Char,,Record 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,,Record 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,,Record Qualifier,"Used to identify the common species name of the subject (i.e., test system) under study (e.g., ""MOUSE"", ""RAT"", ""DOG"", ""MONKEY""). Not to be used with human clinical trials."
STRAIN,Strain/Substrain,Char,,Record 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""). Not to be used with human clinical trials."
SBSTRAIN,Strain/Substrain Details,Char,,Variable Qualifier of STRAIN,"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. Not to be used with human clinical trials."
ARMCD,Planned Arm Code,Char,,Record Qualifier,"Short name for the Arm to which the subject was assigned, limited to 20 characters."
ARM,Description of Planned Arm,Char,,Synonym Qualifier of ARMCD,Name of the Arm to which the subject was assigned.
ACTARMCD,Actual Arm Code,Char,,Record 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,,Synonym Qualifier of ACTARMCD,Description of the actual Arm in which the subject participated during the trial.
ARMNRS,Reason Arm and/or Actual Arm is Null,Char,,Record Qualifier,"The reason why the actual arm variables are null or why both the planned and actual arm variables are null. Examples: ""SCREEN FAILURE"", ""NOT ASSIGNED"", ""NOT TREATED"", ""UNPLANNED TREATMENT"". It is assumed that if the arm and actual arm variables are null, the same reason applies to both."
ACTARMUD,Description of Unplanned Actual Arm,Char,,Record Qualifier,A description of actual treatment for a subject who did not receive treatment described in one of the planned trial arms.
SETCD,Set Code,Char,,Record Qualifier,"Short name of a specific Trial Set, as defined by the sponsor (see Section 3.1.4, Trial Sets). Maximum of 8 characters. This represents the code for the Trial Set for which parameters are being submitted."
RPATHCD,Planned Repro Path Code,Char,,Record 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,ISO 3166-1 Alpha-3,Record Qualifier,Country of the investigation site at which the subject participated in the trial.
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.
