Each study must include 1 standardized set of observations in a specific structure; this is the Demographics domain described here. Demographics is the parent domain for all other observations for subjects and should be identified with the domain code of "DM". The DM domain describes the essential characteristics of the study subjects, and is used by reviewers for selecting subsets of subjects for analysis. The DM domain, as with other datasets, includes identifiers, a topic variable, timing variables, and qualifiers. See the respective implementation guides for further guidance regarding use of additional identifier and timing variables.
Subject Demographics Domain Variables
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| # | Variable Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STUDYID | Study Identifier | Char | Identifier | C83082 | A sequence of characters used by the sponsor to uniquely identify the study. | |||||
| 2 | DOMAIN | Domain Abbreviation | Char | Identifier | C49558 | An abbreviation for a collection of observations, with a topic-specific commonality. | 2-character abbreviation, which must be "DM". | ||||
| 3 | USUBJID | Unique Subject Identifier | Char | Identifier | C69256 | A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product. | |||||
| 4 | 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. | ||||||
| 5 | RFSTDTC | Subject Reference Start Date/Time | Char | ISO 8601 datetime or interval | Record Qualifier | C83395 | The start date or date and time of the sponsor-defined study reference period, represented in a standardized character format. | Usually equivalent to date/time when subject was first exposed to study treatment or product. 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. | |||
| 6 | RFENDTC | Subject Reference End Date/Time | Char | ISO 8601 datetime or interval | Record Qualifier | C83394 | The end date or date and time of the sponsor-defined study reference period, represented in a standardized character format. | Usually equivalent to the date/time when a subject was determined to have ended the trial. Often equivalent to either date/time of last exposure to study treatment or product or date/time of last contact with the subject. Required for all randomized subjects; null for screen failures or unassigned subjects. | |||
| 7 | RFXSTDTC | Date/Time of First Study Exposure | Char | ISO 8601 datetime or interval | Record Qualifier | C170502 | The start date or date and time of the first exposure to any protocol-specified treatment, therapy, or product represented in a standardized character format. | ||||
| 8 | RFXENDTC | Date/Time of Last Study Exposure | Char | ISO 8601 datetime or interval | Record Qualifier | C170501 | The end date or date and time of the last exposure to any protocol-specified treatment, therapy, or product represented in a standardized character format. | ||||
| 9 | RFCSTDTC | Date/Time of First Challenge Agent Admin | Char | ISO 8601 datetime or interval | Record Qualifier | The start date or date and time of the first exposure to any protocol-specified challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent, represented in a standardized character format. Equal to the earliest value of AGSTDTC for the challenge agent. | |||||
| 10 | RFCENDTC | Date/Time of Last Challenge Agent Admin | Char | ISO 8601 datetime or interval | Record Qualifier | The end date or date and time of the last exposure to any protocol-specified challenge agent that induces the disease or condition that the investigational treatment is intended to cure, mitigate, treat, or prevent, represented in a standardized character format. Equal to the latest value of AGENDTC for the challenge agent. | |||||
| 11 | RFICDTC | Date/Time of Informed Consent | Char | ISO 8601 datetime or interval | Record Qualifier | Not in nonclinical trials | C117452 | The date or date and time of informed consent, represented in a standardized character format. | |||
| 12 | RFPENDTC | Date/Time of End of Participation | Char | ISO 8601 datetime or interval | Record Qualifier | Not in nonclinical trials | C117453 | The date or date and time of last contact with or information about a subject in a trial, represented in a standardized character format. | Should correspond to the last known date of contact. | ||
| 13 | DTHDTC | Date/Time of Death | Char | ISO 8601 datetime or interval | Record Qualifier | Not in nonclinical trials | C117450 | The date or date and time of death, represented in a standardized character format. | Should represent the date/time that is captured in the clinical-trial database. | ||
| 14 | DTHFL | Subject Death Flag | Char | Record Qualifier | Not in nonclinical trials | C117451 | An indication that the subject died. | A value of "Y" indicates the subject died. Should be "Y" or null. Should be populated even when the death date is unknown. | |||
| 15 | SITEID | Study Site Identifier | Char | Record Qualifier | C83081 | A sequence of characters used to uniquely identify the facility associated with study-specific activities. | |||||
| 16 | INVID | Investigator Identifier | Char | Record Qualifier | Not in nonclinical trials | 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. | |||||
| 17 | INVNAM | Investigator Name | Char | Synonym Qualifier | INVID | Not in nonclinical trials | Name of the investigator for a site. | ||||
| 18 | BRTHDTC | Date/Time of Birth | Char | ISO 8601 datetime or interval | Record Qualifier | C83217 | The date or date and time of birth, represented in a standardized character format. | ||||
| 19 | AGE | Age | Num | Record Qualifier | C170981 | A numeric representation of the elapsed time since birth at a specific point in time defined for the trial, used for study data tabulation. | May be derived as (RFSTDTC-BRTHDTC), but BRTHDTC may not be available in all cases (due to subject privacy concerns). | ||||
| 20 | AGETXT | Age Text | Char | number-number | Record Qualifier | C170982 | The age at a specific point in time defined for the trial, expressed as a range. | 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. | |||
| 21 | AGEU | Age Units | Char | Variable Qualifier | AGE; AGETXT | C50400 | The unit of time used to express the age, using standardized values. | ||||
| 22 | SEX | Sex | Char | Record Qualifier | Sex of the subject. | ||||||
| 23 | RACE | Race | Char | Record Qualifier | Not in nonclinical trials | Race of the subject. Sponsors should refer to FDA guidance regarding the collection of race data. | |||||
| 24 | ETHNIC | Ethnicity | Char | Record Qualifier | Not in nonclinical trials | The ethnicity of the subject. Sponsors should refer to FDA guidance regarding the collection of ethnicity data. | |||||
| 25 | SPECIES | Species | Char | Record Qualifier | Not in human clinical trials | C96433 | The common (non-taxonomic) name for an animal used as the test system in a study. | "MOUSE", "RAT", "DOG", "MONKEY" | |||
| 26 | STRAIN | Strain/Substrain | Char | Record Qualifier | Not in human clinical trials | C14419 | The vendor-supplied species/strain/substrain designation for the test system under study. It may combine the species, background strain, substrain, and associated genetic modifications as supplied by the vendor (e.g. FISCHER 344, SPRAGUE-DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, RHESUS, CHIMPANZEE). | "C57BL/6", "A/J", "B6.129-Pparg<tm2Rev>/J", "FISCHER 344", "SPRAGUE DAWLEY IGS", "WISTAR Kyoto", "BEAGLE", "CYNOMOLGUS", "CHIMPANZEE" | |||
| 27 | SBSTRAIN | Strain/Substrain Details | Char | Variable Qualifier | STRAIN | Not in human clinical trials | C90460 | Additional clarifying details regarding the test system under study, such as a description of a phenotypic alteration associated with the specific genetic modification captured or collected in the Strain/Substrain variable. | |||
| 28 | ARMCD | Planned Arm Code | Char | Record Qualifier | C83216 | A short sequence of characters that represents the planned arm to which the subject was assigned. | Limited to 20 characters. | ||||
| 29 | ARM | Description of Planned Arm | Char | Synonym Qualifier | ARMCD | C170984 | The name of the planned arm to which the subject was assigned. | ||||
| 30 | ACTARMCD | Actual Arm Code | Char | Record Qualifier | Not in nonclinical trials | C117449 | A short sequence of characters that represents the arm in which the subject actually participated. | Limited to 20 characters. | |||
| 31 | ACTARM | Description of Actual Arm | Char | Synonym Qualifier | ACTARMCD | Not in nonclinical trials | C117448 | The name of the arm in which the subject actually participated. | |||
| 32 | 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. It is assumed that if the arm and actual arm variables are null, the same reason applies to both. | "SCREEN FAILURE", "NOT ASSIGNED", "NOT TREATED", "UNPLANNED TREATMENT" | |||||
| 33 | ACTARMUD | Description of Unplanned Actual Arm | Char | Record Qualifier | A description of actual treatment or product for a subject who did not receive treatment or the product described in one of the planned trial arms. | ||||||
| 34 | SETCD | Set Code | Char | Record Qualifier | C117457 | The standardized or dictionary-derived short sequence of characters used to represent the trial set. | Defined by the sponsor (see Section 5.1.2, Trial Sets). Maximum of 8 characters. This represents the code for the trial set for which parameters are being submitted. | ||||
| 35 | RPATHCD | Planned Repro Path Code | Char | Record Qualifier | Not in human clinical trials | C170503 | A short sequence of characters that represents the planned reproductive path to which the subject was assigned. | Limited to 20 characters. | |||
| 36 | COUNTRY | Country | Char | ISO 3166-1 Alpha-3 | Record Qualifier | Not in nonclinical trials | C170990 | The country in which the investigational site is located. | |||
| 37 | DMDTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | C83243 | The date or date and time of demographic data collection, represented in a standardized character format. | ||||
| 38 | DMDY | Study Day of Collection | Num | Timing | C83244 | The actual study day of demographic data collection derived relative to the sponsor-defined reference start date. | The sponsor-defined reference start date is RFSTDTC. |
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