Substance Use
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Unique identifier for a study. Controlled Terms or Format (if applicable): NA
text
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Two-character abbreviation for the domain. Controlled Terms or Format (if applicable): SU
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Controlled Terms or Format (if applicable): NA
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. Controlled Terms or Format (if applicable): NA
integer
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Used to tie together a block of related records in a single domain for a subject. Controlled Terms or Format (if applicable): NA
Role: Identifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Topic CDISC Notes (for domains) Description (for General Classes): Substance name. Examples: "Cigarettes", "Coffee". Controlled Terms or Format (if applicable): NA
Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): If SUTRT is modified, then the modified text is placed here. Controlled Terms or Format (if applicable): NA
Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): Used to define a category of related records. Examples: "TOBACCO", "ALCOHOL", or "CAFFEINE". Controlled Terms or Format (if applicable): NA
Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): A further categorization of substance use. Examples: "CIGARS", "CIGARETTES", "BEER", "WINE". Controlled Terms or Format (if applicable): NA
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Used to indicate whether ("Y"/null) information about the use of a specific substance was solicited on the CRF. Controlled Terms or Format (if applicable): (NY), not extensible
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): (NY), not extensible
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): (ND)
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Describes the reason substance use was not collected. Used in conjunction with SUSTAT when value of SUSTAT is "NOT DONE". Controlled Terms or Format (if applicable): NA
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Code corresponding to SUCLAS. May be obtained from coding. Controlled Terms or Format (if applicable): NA
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Amount of SUTRT consumed. Not populated if SUDOSTXT is populated. Controlled Terms or Format (if applicable): NA
float
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Substance use consumption amounts or a range of consumption information collected in text form. Not populated if SUDOSE is populated. Controlled Terms or Format (if applicable): NA
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Units for SUDOSE, SUDOSTOT, or SUDOSTXT. Examples: "OUNCES", "CIGARETTE EQUIVALENTS", "GRAMS". Controlled Terms or Format (if applicable): (UNIT), extensible
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Dose form for SUTRT. Examples: "INJECTABLE", "LIQUID", or "POWDER". Controlled Terms or Format (if applicable): NA
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Usually expressed as the number of repeated administrations of SUDOSE within a specific time period. Example: "Q24H" (every day). Controlled Terms or Format (if applicable): (FREQ), extensible
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Route of administration for SUTRT. Examples: "ORAL", "INTRAVENOUS". Controlled Terms or Format (if applicable): (ROUTE), extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Epoch associated with the start date/time of the substance use. Null for substances that started before study participation. Controlled Terms or Format (if applicable): (EPOCH), extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): Start date/time of the substance use represented in ISO 8601 character format. Controlled Terms or Format (if applicable): ISO 8601
datetime
Role: Timing CDISC Notes (for domains) Description (for General Classes): End date/time of the substance use represented in ISO 8601 character format. Controlled Terms or Format (if applicable): ISO 8601
Role: Timing CDISC Notes (for domains) Description (for General Classes): Study day of start of substance use relative to the sponsor-defined RFSTDTC. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): Study day of end of substance use relative to the sponsor-defined RFSTDTC. Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): ISO 8601
durationDatetime
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): (STENRF), not extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): (STENRF), not extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): (STENRF), not extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): Description or date/time in ISO 8601 character format of the reference point referred to by SUSTRTPT. Examples: "2003-12-15" or "VISIT 1". Controlled Terms or Format (if applicable): NA
Role: Timing CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): (STENRF), not extensible
Role: Timing CDISC Notes (for domains) Description (for General Classes): Description or date/time in ISO 8601 character format of the reference point referred to by SUENRTPT. Examples: "2003-12-25" or "VISIT 2". Controlled Terms or Format (if applicable): NA