| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req |
| DOMAIN | Domain Abbreviation | Char | Identifier | Two-character abbreviation for the domain. | Req |
| USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. This must be a unique number, and could be a compound identifier formed by concatenating STUDYID-SITEID-SUBJID. | Req |
| 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. | Req |
| RFSTDTC | Subject Reference Start Date/Time | Char | Record 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. | Exp |
| RFENDTC | Subject Reference End Date/Time | Char | Record 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. | Exp |
| RFXSTDTC | Date/Time of First Study Treatment | Char | Record Qualifier | First date of exposure to any protocol-specified treatment or therapy, equal to the earliest value of EXSTDTC. | Exp |
| RFXENDTC | Date/Time of Last Study Treatment | Char | Record Qualifier | Last date of exposure to any protocol-specified treatment or therapy, equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is missing). | Exp |
| RFICDTC | Date/Time of Informed Consent | Char | Record Qualifier | Date/time of informed consent in ISO 8601 character format. This will be the same as the date of informed consent in the Disposition domain, if that protocol milestone is documented. Would be null only in studies not collecting the date of informed consent. | Exp |
| RFPENDTC | Date/Time of End of Participation | Char | Record Qualifier | Date/time when subject ended participation or follow-up in a trial, as defined in the protocol, in ISO 8601 character format. Should correspond to the last known date of contact. Examples include completion date, withdrawal date, last follow-up, date recorded for lost to follow up, or death date. | Exp |
| DTHDTC | Date/Time of Death | Char | 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. | Exp |
| DTHFL | Subject Death Flag | Char | Record Qualifier | Indicates the subject died. Should be Y or null. Should be populated even when the death date is unknown. | Exp |
| SITEID | Study Site Identifier | Char | Record Qualifier | Unique identifier for a site within a study. | Req |
| INVID | Investigator Identifier | Char | Record Qualifier | An identifier to describe the Investigator for the study. May be used in addition to SITEID. Not needed if SITEID is equivalent to INVID. | Perm |
| INVNAM | Investigator Name | Char | Synonym Qualifier | Name of the investigator for a site. | Perm |
| BRTHDTC | Date/Time of Birth | Char | Record Qualifier | Date/time of birth of the subject. | Perm |
| AGE | Age | Num | Record Qualifier | Age expressed in AGEU. May be derived from RFSTDTC and BRTHDTC, but BRTHDTC may not be available in all cases (due to subject privacy concerns). | Exp |
| AGEU | Age Units | Char | Variable Qualifier | Units associated with AGE. | Exp |
| SEX | Sex | Char | Record Qualifier | Sex of the subject. | Req |
| RACE | Race | Char | Record 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/RegulatoryInformation/Guidances/ucm126340.htm) See Assumption below regarding RACE. | Exp |
| ETHNIC | Ethnicity | Char | Record 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/RegulatoryInformation/Guidances/ucm126340.htm). | Perm |
| ARMCD | Planned Arm Code | Char | Record Qualifier | ARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ARMCD is longer than for other “short” variables to accommodate the kind of values that are likely to be needed for crossover trials. For example, if ARMCD values for a seven-period crossover were constructed using two-character abbreviations for each treatment and separating hyphens, the length of ARMCD values would be 20. | Req |
| ARM | Description of Planned Arm | Char | Synonym Qualifier | Name of the Arm to which the subject was assigned. | Req |
| ACTARMCD | Actual Arm Code | Char | Record Qualifier | Code of actual Arm. When an Arm is not planned (not in Trial Arms), ACTARMCD will be UNPLAN. Randomized subjects who were not treated will be given a value of NOTTRT. Values should be “SCRNFAIL” for screen failures and “NOTASSGN” for subjects not assigned to treatment. Restricted to values in Trial Arms in all other cases. ACTARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ACTARMCD is longer than for other short variables to accommodate the kind of values that are likely to be needed for crossover trials | Req |
| ACTARM | Description of actual Arm | Char | Synonym Qualifier | Description of actual Arm. When an Arm is not planned (not in Trial Arms), ACTARM will be “Unplanned Treatment”. Randomized subjects who were not treated will be given a value of “Not Treated”. Values should be “Screen Failure” for screen failures and “Not Assigned” for subjects not assigned to treatment. Restricted to values in Trial Arms in all other cases. | Req |
| COUNTRY | Country | Char | Record Qualifier | Country of the investigational site in which the subject participated in the trial. | Req |
| DMDTC | Date/Time of Collection | Char | Timing | Date/time of demographic data collection. | Perm |
| DMDY | Study Day of Collection | Num | Timing | Study day of collection measured as integer days. | Perm |