You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 3 Next »

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharSUIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.Req
SUSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
SUGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain for a subject.Perm
SUSPIDApplicant-Defined IdentifierChar
IdentifierApplicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on a Tobacco & Alcohol Use CRF page.Perm
SUTRTReported Name of SubstanceChar
TopicSubstance name. Examples: "CIGARETTES", "COFFEE".Req
SUMODIFYModified Substance NameChar
Synonym QualifierIf SUTRT is modified, then the modified text is placed here.Perm
SUDECODStandardized Substance NameChar
Synonym QualifierStandardized or dictionary-derived text description of SUTRT or SUMODIFY if the applicant chooses to code the substance use.Perm
SUCATCategory for Substance UseChar
Grouping QualifierUsed to define a category of related records. Examples: "TOBACCO", "ALCOHOL", or "CAFFEINE".Perm
SUSCATSubcategory for Substance UseChar
Grouping QualifierA further categorization of substance use. Examples: "CIGARS", "CIGARETTES", "BEER", "WINE".Perm
SUPRESPSU Pre-SpecifiedChar(NY)Variable QualifierUsed to indicate whether ("Y"/null) information about the use of a specific substance was solicited on the CRF.Perm
SUOCCURSU OccurrenceChar(NY)Record QualifierWhen the use of specific substances is solicited, SUOCCUR is used to indicate whether ("Y"/"N") a particular prespecified substance was used. Values are null for substances not specifically solicited.Perm
SUSTATCompletion StatusChar(ND)Record QualifierWhen the use of prespecified substances is solicited, the completion status indicates that there was no response to the question about the prespecified substance. When there is no prespecified list on the CRF, then the completion status indicates that substance use was not assessed for the subject.Perm
SUREASNDReason Substance Use Not CollectedChar
Record QualifierDescribes the reason substance use was not collected. Used in conjunction with SUSTAT when value of SUSTAT is "NOT DONE".Perm
SUCLASSubstance Use ClassChar
Variable QualifierSubstance 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
SUCLASCDSubstance Use Class CodeChar
Variable QualifierCode corresponding to SUCLAS. May be obtained from coding.Perm
SUDOSESubstance Use ConsumptionNum
Record QualifierAmount of SUTRT consumed. Not populated if SUDOSTXT is populated.Perm
SUDOSTXTSubstance Use Consumption TextChar
Record QualifierSubstance use consumption amounts or a range of consumption information collected in text form. Not populated if SUDOSE is populated.Perm
SUDOSUConsumption UnitsChar(UNIT)Variable Qualifier

Units for SUDOSE, SUDOSTOT, or SUDOSTXT. Examples: "oz", "CIGARETTE", "PACK", "g".

Perm
SUDOSFRMDose FormChar(FRM)Variable QualifierDose form for SUTRT. Examples: "INJECTABLE", "LIQUID", "POWDER".Perm
SUDOSFRQUse Frequency Per IntervalChar(FREQ)Variable QualifierUsually expressed as the number of repeated administrations of SUDOSE within a specific time period. Example: "Q24H" (every day).Perm
SUDOSTOTTotal Daily ConsumptionNum
Record QualifierTotal daily use of SUTRT using the units in SUDOSU. Used when dosing is collected as total daily dose. If an applicant needs to aggregate the data over a period other than daily, then the aggregated total could be recorded in a supplemental qualifier variable.Perm
SUROUTERoute of AdministrationChar(ROUTE)Variable QualifierRoute of administration for SUTRT. Examples: "ORAL", "INTRAVENOUS".Perm
TAETORDPlanned Order of Element within ArmNum
TimingNumber 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
EPOCHEpochChar(EPOCH)TimingEpoch associated with the start date/time of the substance use. Null for substances that started before study participation.Perm
SUSTDTCStart Date/Time of Substance UseCharISO 8601 datetime or intervalTimingStart date/time of the substance use represented in ISO 8601 character format.Perm
SUENDTCEnd Date/Time of Substance UseCharISO 8601 datetime or intervalTimingEnd date/time of the substance use represented in ISO 8601 character format.Perm
SUSTDYStudy Day of Start of Substance UseNum
TimingStudy day of start of substance use relative to the applicant-defined RFSTDTC.Perm
SUENDYStudy Day of End of Substance UseNum
TimingStudy day of end of substance use relative to the applicant-defined RFSTDTC.Perm
SUDURDuration of Substance UseCharISO 8601 durationTimingCollected 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
SUSTRFStart Relative to Reference PeriodChar(STENRF)Timing

Describes the start of the substance use relative to the applicant-defined reference period. The applicant-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.

Perm
SUENRFEnd Relative to Reference PeriodChar(STENRF)Timing

Describes the end of the substance use with relative to the applicant-defined reference period. The applicant-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.

Perm
SUSTRTPTStart Relative to Reference Time PointChar(STENRF)Timing

Identifies the start of the substance as being before or after the reference time point defined by variable SUSTTPT.

Perm
SUSTTPTStart Reference Time PointChar
TimingDescription or date/time in ISO 8601 character format of the reference point referred to by SUSTRTPT. Examples: "2003-12-15", "VISIT 1".Perm
SUENRTPTEnd Relative to Reference Time PointChar(STENRF)Timing

Identifies the end of the substance as being before or after the reference time point defined by variable SUENTPT.

Perm
SUENTPTEnd Reference Time PointChar
TimingDescription or date/time in ISO 8601 character format of the reference point referred to by SUENRTPT. Examples: "2003-12-25", "VISIT 2".Perm

Assumptions


  1. Substance use information may be independent of planned study evaluations, or may be a key outcome (e.g., planned evaluation) of a clinical study.

    1. In many clinical studies, detailed substance use information as provided for in the domain model above may not be required (e.g., the only information collected may be a response to the question “Have you ever smoked tobacco?”); in such cases, many of the qualifier variables would not be submitted.
    2. SU may contain responses to questions about use of prespecified substances as well as records of substance use collected as free text.
  2. SU description and coding
    1. SUTRT captures the verbatim or the prespecified text collected for the substance. It is the topic variable for the SU dataset. SUTRT is a required variable and must have a value.
    2. SUMODIFY is a permissible variable and should be included if coding is performed and the applicant’s procedure permits modification of a verbatim substance use term for coding. The modified term is listed in SUMODIFY. The variable may be populated as per the applicant's procedures.
    3. SUDECOD is the preferred term derived by the applicant from the coding dictionary if coding is performed. It is a permissible variable. Where deemed necessary by the applicant the verbatim term (SUTRT) should be coded using a standard dictionary such as WHO Drug. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the external codelist element in the Define-XML document.
  3. Additional categorization and grouping
    1. SUCAT and SUSCAT should not be redundant with the domain code or dictionary classification provided by SUDECOD, or with SUTRT. That is, they should provide a different means of defining or classifying SU records. For example, an applicant may be interested in identifying all substances that the investigator feels might represent opium use, and to collect such use on a separate CRF page. This categorization might differ from the categorization derived from the coding dictionary.
    2. SUGRPID may be used to link (or associate) different records together to form a block of related records within SU at the subject level). It should not be used in place of SUCAT or SUSCAT.
  4. Timing variables
    1. SUSTDTC and SUENDTC may be populated as required.
    2. If substance use information is collected more than once within the CRF (indicating that the data are visit-based) then VISITNUM would be added to the domain as an additional timing variable. VISITDY and VISIT would then be permissible variables.
  5. Any additional qualifiers from the Interventions class may be added to the SU domain, but the following qualifiers would generally not be used: --MOOD, --LOT.

  • No labels