| 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. See Assumption 9 for additional
detail on when RFSTDTC may be null. |
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/time 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/time 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, October, 2016) for
guidance regarding the collection of race
(https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126396.pdf)
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,
October, 2016) for guidance regarding the collection of ethnicity
(https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126396.pdf).
|
Perm |
| ARMCD |
Planned Arm Code |
Char |
Record Qualifier |
ARMCD is limited to 20 characters. It is not subject to the
character restrictions that apply to TESTCD.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. If the
subject was not assigned to an Arm, ARMCD is null and ARMNRS is
populated. With the exception of studies which use multi-stage Arm
assignments, must be a value of ARMCD in the Trial Arms Dataset. |
Exp |
| ARM |
Description of Planned Arm |
Char |
Synonym Qualifier |
Name of the Arm to which the subject was assigned. If the
subject was not assigned to an Arm, ARM is null and ARMNRS is
populated. With the exception of studies which use multi-stage Arm
assignments, must be a value of ARM in the Trial Arms Dataset. |
Exp |
| ACTARMCD |
Actual Arm Code |
Char |
Record Qualifier |
Code of actual Arm. ACTARMCD is limited to 20 characters. It
is not subject to the character restrictions that apply to TESTCD.
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. With the exception of studies which use
multi-stage Arm assignments, must be a value of ARMCD in the Trial
Arms Dataset. If the subject was not assigned to an Arm or followed
a course not described by any planned Arm, ACTARMCD is null and
ARMNRS is populated. |
Exp |
| ACTARM |
Description of Actual Arm |
Char |
Synonym Qualifier |
Description of actual Arm. With the exception of studies
which use multi-stage Arm assignments, must be a value of ARM in the
Trial Arms Dataset. If the subject was not assigned to an Arm or
followed a course not described by any planned Arm, ACTARM is null
and ARMNRS is populated. |
Exp |
| ARMNRS |
Reason Arm and/or Actual Arm is Null |
Char |
Record Qualifier |
A coded reason that Arm variables (ARM and ARMCD) and/or
actual Arm variables (ACTARM and ACTARMCD) are null. Examples:
"SCREEN FAILURE", "NOT ASSIGNED", "ASSIGNED, NOT TREATED",
"UNPLANNED TREATMENT". It is assumed that if the Arm and actual Arm
variables are null, the same reason applies to both Arm and actual
Arm. |
Exp |
| 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. |
Exp |
| 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 |