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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 AbbreviationCharECIdentifierTwo-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
ECSEQSequence NumberNum
IdentifierSequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
ECGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain for a subject.Perm
ECREFIDReference IDChar
IdentifierInternal or external identifier (e.g., kit number, bottle label, vial identifier).Perm
ECSPIDApplicant-Defined IdentifierChar
IdentifierApplicant-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on a CRF Page.Perm
ECLNKIDLink IDChar
IdentifierIdentifier used to link related records across domains.Perm
ECLNKGRPLink Group IDChar
IdentifierIdentifier used to link related, grouped records across domains.Perm
ECTRTName of ProductChar
TopicName of the product known to the subject and/or administrator.Req
ECMOODMoodChar(BRDGMOOD)Record QualifierMode or condition of the record specifying whether the intervention (activity) is intended to happen or has happened. Values align with BRIDG pillars (e.g., scheduled context, performed context) and HL7 activity moods (e.g., intent, event). Examples: "SCHEDULED", "PERFORMED".Perm
ECCATCategory of ProductChar
Grouping QualifierUsed to define a category of related ECTRT values.Perm
ECSCATSubcategory of ProductChar
Grouping QualifierA further categorization of ECCAT values.Perm
ECPRESPPre-SpecifiedChar(NY)Variable QualifierUsed when a specific intervention is pre-specified. Values should be "Y" or null.Perm
ECOCCUROccurrenceChar(NY)Record QualifierUsed to indicate whether an exposure occurred when information about the occurrence is solicited. ECOCCUR = "N" when a product was not taken, not given, or missed.Perm
ECDOSEDoseNum
Record QualifierAmount of ECTRT when numeric. Not populated when ECDOSTXT is populated.Exp
ECDOSTXTDose DescriptionChar
Record QualifierAmount of ECTRT when non-numeric. Dosing amounts or a range of dosing information collected in text form. Example: "200-400". Not populated when ECDOSE is populated.Perm
ECDOSUDose UnitsChar(UNIT)Variable QualifierUnits for ECDOSE, ECDOSTOT, or ECDOSTXT.Exp
ECDOSFRMDose FormChar(FRM)Variable QualifierDose form for ECTRT.Exp
ECDOSFRQDosing Frequency per IntervalChar(FREQ)Variable QualifierUsually expressed as the number of repeated administrations of ECDOSE within a specific time period. Examples: "Q2H", "QD", "BID".Perm
ECDOSTOTTotal Daily DoseNum
Record QualifierTotal daily dose of ECTRT using the units in ECDOSU. Used when dosing is collected as Total Daily Dose.Perm
ECDOSRGMIntended Dose RegimenChar
Variable QualifierText description of the intended schedule or regimen for the Intervention. Example: "TWO WEEKS ON", "TWO WEEKS OFF".Perm
ECROUTERoute of AdministrationChar(ROUTE)Variable QualifierRoute of administration for the intervention. Examples: "ORAL".Perm
ECLOTLot NumberChar
Record QualifierLot Number of the ECTRT product.Perm
ECLOCLocation of Dose AdministrationChar(LOC)Record QualifierSpecifies location of administration. Example: "ARM", "LIP".Perm
ECLATLateralityChar(LAT)Variable QualifierQualifier for anatomical location further detailing laterality of the intervention administration. Examples: "LEFT", "RIGHT".Perm
ECDIRDirectionalityChar(DIR)Variable QualifierQualifier for anatomical location further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL", "UPPER".Perm
ECPORTOTPortion or TotalityChar(PORTOT)Variable QualifierQualifier for anatomical location further detailing distribution, which means arrangement of, apportioning of. Examples: "ENTIRE", "SINGLE", "SEGMENT".Perm
ECPSTRGPharmaceutical StrengthNum
Record QualifierAmount of an active ingredient expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form.Perm
ECPSTRGUPharmaceutical Strength UnitsChar
Variable QualifierUnit for ECPSTRG. Examples: "mg/TABLET", "mg/mL".Perm
ECADJReason for Dose AdjustmentChar
Record QualifierDescribes reason or explanation of why a dose is adjusted.Perm
TAETORDPlanned Order of Element within ArmNum
TimingNumber that gives the planned order of the Element within the Arm.Perm
EPOCHEpochChar(EPOCH)TimingTrial Epoch of the exposure as collected record. Examples: "RUN-IN".Perm
ECSTDTCStart Date/Time of ExposureCharISO 8601 datetime or intervalTimingThe date/time when administration of the product indicated by ECTRT and ECDOSE began.Exp
ECENDTCEnd Date/Time of ExposureCharISO 8601 datetime or intervalTimingThe date/time when administration of the product indicated by ECTRT and ECDOSE ended. For administrations considered given at a point in time (e.g., oral tablet, pre-filled syringe injection), where only an administration date/time is collected, ECSTDTC should be copied to ECENDTC as the standard representation.Exp
ECSTDYStudy Day of Start of ExposureNum
TimingStudy day of ECSTDTC relative to the applicant-defined DM.RFSTDTC.Perm
ECENDYStudy Day of End ExposureNum
TimingStudy day of ECENDTC relative to the applicant-defined DM.RFSTDTC.Perm
ECDURDuration of ExposureCharISO 8601 durationTimingCollected duration of administration. Used only if collected on the CRF and not derived from start and end date/times.Perm
ECTPTPlanned Time Point NameChar
TimingText Description of time when administration should occur. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See ECTPTNUM and ECTPTREF.Perm
ECTPTNUMPlanned Time Point NumberNum
TimingNumerical version of ECTPT to aid in sorting.Perm
ECELTMPlanned Elapsed Time from Time Point RefCharISO 8601 durationTimingPlanned elapsed time relative to the planned fixed reference (ECTPTREF). This variable is useful where there are repetitive measures. Not a clock time.Perm
ECTPTREFTime Point ReferenceChar
TimingName of the fixed reference point referred to by ECELTM, ECTPTNUM, and ECTPT. Examples: PREVIOUS DOSE.Perm
ECRFTDTCDate/Time of Reference Time PointCharISO 8601 datetime or intervalTimingDate/time for a fixed reference time point defined by ECTPTREF.Perm

Assumptions

  1. EC Definition
    1. The Exposure as Collected domain model reflects protocol-specified study product administrations, as collected.
      1. EC should be used in all cases where collected exposure information cannot or should not be directly represented in EX. For example, administrations collected in mL but protocol-specified unit is mg, or administrations collected in LOZENGE but protocol-specified unit is mg. Product accountability details (e.g., amount dispensed, amount returned) are represented in DA and not in EC.
      2. Collected exposure data are in most cases represented in a combination of one or more of EC, DA, or FA domains. If the entire EC dataset is an exact duplicate of the entire EX dataset, then EC is optional and at the applicant's discretion.
    2. Collected exposure log data points descriptive of administrations typically reflect amounts at the product-level (e.g., number of tablets, number of mL).
  2. Product Description
    1. ECTRT is applicant defined and should reflect how the protocol-specified study product is known or referred to in data collection. In an open-label study, ECTRT should store the product name. In a masked study, if product is collected and known as Product A to the subject or administrator, then ECTRT = "PRODUCT A". If in a masked study the product is not known by a synonym and the data are to be exchanged between applicants, partners and/or regulatory agency(s), then assign ECTRT the value of "MASKED".
  3. ECMOOD is permissible; when implemented, it must be populated for all records.
    1. Values of ECMOOD, to date include:
      1. "SCHEDULED" (for collected subject-level intended dose records)
      2. "PERFORMED" (for collected subject-level actual dose records)
    2. Qualifier variables should be populated with equal granularity across Scheduled and Performed records when known. For example, if ECDOSU and ECDOSFRQ are known at scheduling and administration, then the variables would be populated on both records. If ECLOC is determined at the time of administration, then it would be populated on the performed record only.
    3. Appropriate Timing variable(s) should be populated. Note: Details on Scheduled records may describe timing at a higher level than Performed records.
    4. ECOCCUR is generally not applicable for Scheduled records.
    5. An activity may be rescheduled or modified multiple times before being performed. Representation of Scheduled records is dependent on the collected, available data. If each rescheduled or modified activity is collected, then multiple Scheduled records may be represented. If only the final Scheduled activity is collected, then it would be the only scheduled record represented.
  4. Doses Not Taken, Not Given, or Missed
    1. The record qualifier --OCCUR, with value of "N", is available in domains based on the Interventions and Events General Observation Classes as the standard way to represent whether an intervention or event did not happen. In the EC domain, ECOCCUR value of "N" indicates a dose was not taken, not given, or missed. For example, if 0 tablets are taken within a timeframe or 0 mL is infused at a visit, then ECOCCUR = "N" is the standard representation of the collected doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to zero (0) as an alternative method for indicating doses not taken, not given, or missed.
    2. The population of Qualifier variables (e.g., Grouping, Record, Variable) and additional Timing variables (e.g., date of collection, visit, time point) for records representing information collected about doses not taken, not given, or missed should be populated with equal granularity as administered records, when known and/or applicable. Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be populated with positive (non-zero) values in cases where the applicant feels it is necessary and/or appropriate to represent specific dose amounts not taken, not given, or missed.
  5. Timing Variables
    1. Timing variables in the EC domain should reflect administrations by the intervals they were collected (e.g., constant-dosing intervals, visits, targeted dates like first dose, last dose).
    2. For administrations considered given at a point in time (e.g., oral tablet, pre-filled syringe injection), where only an administration date/time is collected, ECSTDTC should be copied to ECENDTC.
  6. The degree of summarization of records from EC to EX is applicant defined to support study purpose and analysis. When the relationship between EC and EX records can be described in RELREC, then it should be defined.
  7. Additional Interventions Qualifiers
    1. --DOSTOT is under evaluation for potential deprecation and replacement with a mechanism to describe total dose over any interval of time (e.g., day, week, month). Applicants considering ECDOSTOT may want to consider using other dose amount variables (ECDOSE or ECDOSTXT) in combination with frequency (ECDOSFRQ) and timing variables to represent the data.
    2.  Any Identifier variables, Timing variables, or Findings general-observation-class qualifiers may be added to the EC domain, but the following qualifiers would generally not be used in EC:  --STAT, --REASND, --VAMT, and --VAMTU.

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