SDTM.SU

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	SU	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	SU	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	SU	USUBJID	Unique Subject Identifier	Char		Identifier	Req	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4	SU	SUSEQ	Sequence Number	Num		Identifier	Req	Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	SU	SUGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
6	SU	SUSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	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.
7	SU	SUTRT	Reported Name of Substance	Char		Topic	Req	Substance name. Examples: "Cigarettes", "Coffee".
8	SU	SUMODIFY	Modified Substance Name	Char		Synonym Qualifier	Perm	If SUTRT is modified, then the modified text is placed here.
9	SU	SUDECOD	Standardized Substance Name	Char		Synonym Qualifier	Perm	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.
10	SU	SUCAT	Category for Substance Use	Char		Grouping Qualifier	Perm	Used to define a category of related records. Examples: "TOBACCO", "ALCOHOL", or "CAFFEINE".
11	SU	SUSCAT	Subcategory for Substance Use	Char		Grouping Qualifier	Perm	A further categorization of substance use. Examples: "CIGARS", "CIGARETTES", "BEER", "WINE".
12	SU	SUPRESP	SU Pre-Specified	Char	C66742	Variable Qualifier	Perm	Used to indicate whether ("Y"/null) information about the use of a specific substance was solicited on the CRF.
13	SU	SUOCCUR	SU Occurrence	Char	C66742	Record Qualifier	Perm	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.
14	SU	SUSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	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.
15	SU	SUREASND	Reason Substance Use Not Collected	Char		Record Qualifier	Perm	Describes the reason substance use was not collected. Used in conjunction with SUSTAT when value of SUSTAT is "NOT DONE".
16	SU	SUCLAS	Substance Use Class	Char		Variable Qualifier	Perm	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.
17	SU	SUCLASCD	Substance Use Class Code	Char		Variable Qualifier	Perm	Code corresponding to SUCLAS. May be obtained from coding.
18	SU	SUDOSE	Substance Use Consumption	Num		Record Qualifier	Perm	Amount of SUTRT consumed. Not populated if SUDOSTXT is populated.
19	SU	SUDOSTXT	Substance Use Consumption Text	Char		Record Qualifier	Perm	Substance use consumption amounts or a range of consumption information collected in text form. Not populated if SUDOSE is populated.
20	SU	SUDOSU	Consumption Units	Char	C71620	Variable Qualifier	Perm	Units for SUDOSE, SUDOSTOT, or SUDOSTXT. Examples: "OUNCES", "CIGARETTE EQUIVALENTS", "GRAMS".
21	SU	SUDOSFRM	Dose Form	Char		Variable Qualifier	Perm	Dose form for SUTRT. Examples: "INJECTABLE", "LIQUID", or "POWDER".
22	SU	SUDOSFRQ	Use Frequency Per Interval	Char	C71113	Variable Qualifier	Perm	Usually expressed as the number of repeated administrations of SUDOSE within a specific time period. Example: "Q24H" (every day).
23	SU	SUDOSTOT	Total Daily Consumption	Num		Record Qualifier	Perm	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.
24	SU	SUROUTE	Route of Administration	Char	C66729	Variable Qualifier	Perm	Route of administration for SUTRT. Examples: "ORAL", "INTRAVENOUS".
25	SU	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	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.
26	SU	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the start date/time of the substance use. Null for substances that started before study participation.
27	SU	SUSTDTC	Start Date/Time of Substance Use	Char	ISO 8601	Timing	Perm	Start date/time of the substance use represented in ISO 8601 character format.
28	SU	SUENDTC	End Date/Time of Substance Use	Char	ISO 8601	Timing	Perm	End date/time of the substance use represented in ISO 8601 character format.
29	SU	SUSTDY	Study Day of Start of Substance Use	Num		Timing	Perm	Study day of start of substance use relative to the sponsor-defined RFSTDTC.
30	SU	SUENDY	Study Day of End of Substance Use	Num		Timing	Perm	Study day of end of substance use relative to the sponsor-defined RFSTDTC.
31	SU	SUDUR	Duration of Substance Use	Char	ISO 8601	Timing	Perm	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.
32	SU	SUSTRF	Start Relative to Reference Period	Char	C66728	Timing	Perm	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.
33	SU	SUENRF	End Relative to Reference Period	Char	C66728	Timing	Perm	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.
34	SU	SUSTRTPT	Start Relative to Reference Time Point	Char	C66728	Timing	Perm	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.
35	SU	SUSTTPT	Start Reference Time Point	Char		Timing	Perm	Description or date/time in ISO 8601 character format of the reference point referred to by SUSTRTPT. Examples: "2003-12-15" or "VISIT 1".
36	SU	SUENRTPT	End Relative to Reference Time Point	Char	C66728	Timing	Perm	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.
37	SU	SUENTPT	End Reference Time Point	Char		Timing	Perm	Description or date/time in ISO 8601 character format of the reference point referred to by SUENRTPT. Examples: "2003-12-25" or "VISIT 2".