| 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. |
Req |
| SUSEQ |
Sequence Number |
Num |
Identifier |
Sequence Number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| SUGRPID |
Group ID |
Char |
Identifier |
Used to tie together a block of related records in a single
domain for a subject. |
Perm |
| SUSPID |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor-defined reference number. Perhaps pre-printed on the
CRF as an explicit line identifier or defined in the sponsor's
operational database. Example: Line number on a Tobacco &
Alcohol use CRF page. |
Perm |
| SUTRT |
Reported Name of Substance |
Char |
Topic |
Substance name. Examples: "Cigarettes", "Coffee". |
Req |
| SUMODIFY |
Modified Substance Name |
Char |
Synonym Qualifier |
If SUTRT is modified, then the modified text is placed here.
|
Perm |
| SUDECOD |
Standardized Substance Name |
Char |
Synonym Qualifier |
Standardized or dictionary-derived text description of SUTRT
or SUMODIFY if the sponsor chooses to code the substance use. The
sponsor is expected to provide the dictionary name and version used
to map the terms utilizing the external codelist element in the
Define-XML document. |
Perm |
| SUCAT |
Category for Substance Use |
Char |
Grouping Qualifier |
Used to define a category of related records. Examples:
"TOBACCO", "ALCOHOL", or "CAFFEINE". |
Perm |
| SUSCAT |
Subcategory for Substance Use |
Char |
Grouping Qualifier |
A further categorization of substance use. Examples:
"CIGARS", "CIGARETTES", "BEER", "WINE". |
Perm |
| SUPRESP |
SU Pre-Specified |
Char |
Variable Qualifier |
Used to indicate whether ("Y"/null) information about the
use of a specific substance was solicited on the CRF. |
Perm |
| SUOCCUR |
SU Occurrence |
Char |
Record Qualifier |
When the use of specific substances is solicited, SUOCCUR is
used to indicate whether or not ("Y"/"N") a particular pre-specified
substance was used. Values are null for substances not specifically
solicited. |
Perm |
| SUSTAT |
Completion Status |
Char |
Record Qualifier |
When the use of pre-specified substances is solicited, the
completion status indicates that there was no response to the
question about the pre-specified substance. When there is no
pre-specified list on the CRF, then the completion status indicates
that substance use was not assessed for the subject. |
Perm |
| SUREASND |
Reason Substance Use Not Collected |
Char |
Record Qualifier |
Describes the reason substance use was not collected. Used
in conjunction with SUSTAT when value of SUSTAT is "NOT DONE". |
Perm |
| SUCLAS |
Substance Use Class |
Char |
Variable Qualifier |
Substance use class. May be obtained from coding. When
coding to a single class, populate with class value. If using a
dictionary and coding to multiple classes, then follow Section
4.2.8.3, Multiple Values for a Non-Result Qualifier Variable, or
omit SUCLAS. |
Perm |
| SUCLASCD |
Substance Use Class Code |
Char |
Variable Qualifier |
Code corresponding to SUCLAS. May be obtained from coding. |
Perm |
| SUDOSE |
Substance Use Consumption |
Num |
Record Qualifier |
Amount of SUTRT consumed. Not populated if SUDOSTXT is
populated. |
Perm |
| SUDOSTXT |
Substance Use Consumption Text |
Char |
Record Qualifier |
Substance use consumption amounts or a range of consumption
information collected in text form. Not populated if SUDOSE is
populated. |
Perm |
| SUDOSU |
Consumption Units |
Char |
Variable Qualifier |
Units for SUDOSE, SUDOSTOT, or SUDOSTXT. Examples: "OUNCES",
"CIGARETTE EQUIVALENTS", "GRAMS". |
Perm |
| SUDOSFRM |
Dose Form |
Char |
Variable Qualifier |
Dose form for SUTRT. Examples: "INJECTABLE", "LIQUID", or
"POWDER". |
Perm |
| SUDOSFRQ |
Use Frequency Per Interval |
Char |
Variable Qualifier |
Usually expressed as the number of repeated administrations
of SUDOSE within a specific time period. Example: "Q24H" (every
day). |
Perm |
| SUDOSTOT |
Total Daily Consumption |
Num |
Record Qualifier |
Total daily use of SUTRT using the units in SUDOSU. Used
when dosing is collected as Total Daily Dose. If sponsor needs to
aggregate the data over a period other than daily, then the
aggregated total could be recorded in a Supplemental Qualifier
variable. |
Perm |
| SUROUTE |
Route of Administration |
Char |
Variable Qualifier |
Route of administration for SUTRT. Examples: "ORAL",
"INTRAVENOUS". |
Perm |
| TAETORD |
Planned Order of Element within Arm |
Num |
Timing |
Number that gives the planned order of the Element within
the Arm for the Element in which the substance use started. Null for
substances that started before study participation. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the start date/time of the substance
use. Null for substances that started before study participation. |
Perm |
| SUSTDTC |
Start Date/Time of Substance Use |
Char |
Timing |
Start date/time of the substance use represented in ISO 8601
character format. |
Perm |
| SUENDTC |
End Date/Time of Substance Use |
Char |
Timing |
End date/time of the substance use represented in ISO 8601
character format. |
Perm |
| SUSTDY |
Study Day of Start of Substance Use |
Num |
Timing |
Study day of start of substance use relative to the
sponsor-defined RFSTDTC. |
Perm |
| SUENDY |
Study Day of End of Substance Use |
Num |
Timing |
Study day of end of substance use relative to the
sponsor-defined RFSTDTC. |
Perm |
| SUDUR |
Duration of Substance Use |
Char |
Timing |
Collected duration of substance use in ISO 8601 format. Used
only if collected on the CRF and not derived from start and end
date/times. |
Perm |
| SUSTRF |
Start Relative to Reference Period |
Char |
Timing |
Describes the start of the substance use relative to the
sponsor-defined reference period. The sponsor-defined reference
period is a continuous period of time defined by a discrete starting
point and a discrete ending point (represented by RFSTDTC and
RFENDTC in Demographics). If information such as "PRIOR" was
collected, this information may be translated into SUSTRF. Not all
values of the codelist are allowable for this variable. See Section
4.4.7, Use of Relative Timing Variables. |
Perm |
| SUENRF |
End Relative to Reference Period |
Char |
Timing |
Describes the end of the substance use with relative to the
sponsor-defined reference period. The sponsor-defined reference
period is a continuous period of time defined by a discrete starting
point and a discrete ending point (represented by RFSTDTC and
RFENDTC in Demographics). If information such as "PRIOR", "ONGOING",
or "CONTINUING" was collected, this information may be translated
into SUENRF. Not all values of the codelist are allowable for this
variable. See Section 4.4.7, Use of Relative Timing Variables. |
Perm |
| SUSTRTPT |
Start Relative to Reference Time Point |
Char |
Timing |
Identifies the start of the substance as being before or
after the reference time point defined by variable SUSTTPT. Not all
values of the codelist are allowable for this variable. See Section
4.4.7 , Use of Relative Timing Variables. |
Perm |
| SUSTTPT |
Start Reference Time Point |
Char |
Timing |
Description or date/time in ISO 8601 character format of the
reference point referred to by SUSTRTPT. Examples: "2003-12-15" or
"VISIT 1". |
Perm |
| SUENRTPT |
End Relative to Reference Time Point |
Char |
Timing |
Identifies the end of the substance as being before or after
the reference time point defined by variable SUENTPT. Not all values
of the codelist are allowable for this variable. See Section 4.4.7 ,
Use of Relative Timing Variables. |
Perm |
| SUENTPT |
End Reference Time Point |
Char |
Timing |
Description or date/time in ISO 8601 character format of the
reference point referred to by SUENRTPT. Examples: "2003-12-25" or
"VISIT 2". |
Perm |