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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 define.xml external codelist attributes.
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: 4.1.2.8.3, 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 SUSTDTC Start Date/Time of Substance Use Char ISO 8601 Timing Perm
26 SU SUENDTC End Date/Time of Substance Use Char ISO 8601 Timing Perm
27 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.
28 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.
29 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.
30 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", "ONGOING", or "CONTINUING" was collected, this information may be translated into SUSTRF.
31 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.
32 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.
33 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".
34 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.
35 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".