Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 ML 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 ML 2 DOMAIN Domain Abbreviation Char ML Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 ML 3 USUBJID Unique Subject Identifier Char Identifier Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Req
SDTMIG 3.3 ML 4 MLSEQ Sequence Number Num Identifier Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. Req
SDTMIG 3.3 ML 5 MLGRPID Group ID Char Identifier Used to tie together a block of related records in a single domain for a subject. Perm
SDTMIG 3.3 ML 6 MLSPID Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Examples: a number pre-printed on the CRF as an explicit line identifier or record identifier defined in the sponsor's operational database. Perm
SDTMIG 3.3 ML 7 MLTRT Name of Meal Char Topic Verbatim food product name that is either pre-printed or collected on a CRF. Req
SDTMIG 3.3 ML 8 MLCAT Category for Meal Char Grouping Qualifier Used to define a category of MLTRT values. Perm
SDTMIG 3.3 ML 9 MLSCAT Subcategory for Meal Char Grouping Qualifier Used to define a further categorization of MLCAT values. Perm
SDTMIG 3.3 ML 10 MLPRESP ML Pre-specified Char (NY) Variable Qualifier Used when a specific meal is pre-specified on a CRF. Values should be "Y" or null. Perm
SDTMIG 3.3 ML 11 MLOCCUR ML Occurrence Char (NY) Record Qualifier Used to record whether a pre-specified meal occurred when information about the occurrence of a specific meal is solicited. Perm
SDTMIG 3.3 ML 12 MLSTAT Completion Status Char (ND) Record Qualifier Used to indicate when a question about the occurrence of a pre-specified meal was not answered. Should be null or have a value of "NOT DONE". Perm
SDTMIG 3.3 ML 13 MLREASND Reason Meal Not Collected Char Record Qualifier Describes the reason a response to a question about the occurrence of a meal was not collected. Used in conjunction with MLSTAT when value is "NOT DONE". Perm
SDTMIG 3.3 ML 14 MLDOSE Dose Num Record Qualifier Amount of MLTRT consumed. Not populated when MLDOSTXT is populated. Perm
SDTMIG 3.3 ML 15 MLDOSTXT Dose Description Char Record Qualifier Amount description of MLTRT consumed, collected in text form. Not populated when MLDOSE is populated. Examples: "<1 per day", "200-400". Perm
SDTMIG 3.3 ML 16 MLDOSU Dose Units Char (UNIT) Variable Qualifier Units for MLDOSE, MLDOSTOT, or MLDOSTXT. Perm
SDTMIG 3.3 ML 17 MLDOSFRM Dose Form Char (FRM) Variable Qualifier Dosage form for MLTRT. Example: "BAR, CHEWABLE". Perm
SDTMIG 3.3 ML 18 VISITNUM Visit Number Num Timing Clinical encounter number. Numeric version of VISIT, used for sorting. Perm
SDTMIG 3.3 ML 19 VISIT Visit Name Char Timing Protocol-defined description of a clinical encounter. Perm
SDTMIG 3.3 ML 20 VISITDY Planned Study Day of Visit Num Timing Planned study day of VISIT. Should be an integer. Perm
SDTMIG 3.3 ML 21 TAETORD Planned Order of Element within Arm Num Timing Number that gives the planned order of the Element within the Arm for the Element in which the meal started. Perm
SDTMIG 3.3 ML 22 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the start date/time of the meal. Perm
SDTMIG 3.3 ML 23 MLDTC Date/Time of Collection Char ISO 8601 Timing Collection date and time of the meal represented in ISO 8601 character format. Perm
SDTMIG 3.3 ML 24 MLSTDTC Start Date/Time of Meal Char ISO 8601 Timing Start date/time of the meal represented in ISO 8601 character format. Perm
SDTMIG 3.3 ML 25 MLENDTC End Date/Time of Meal Char ISO 8601 Timing End date/time of the meal represented in ISO 8601 character format. Perm
SDTMIG 3.3 ML 26 MLDY Study Day of Visit/Collection/Exam Num Timing Actual study day of the visit/collection expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. Perm
SDTMIG 3.3 ML 27 MLSTDY Study Day of Start of Meal Num Timing Actual study day of start of the meal expressed in integer days relative to sponsor-defined RFSTDTC in Demographics. Perm
SDTMIG 3.3 ML 28 MLENDY Study Day of End of Meal Num Timing Actual study day of end of the meal expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. Perm
SDTMIG 3.3 ML 29 MLDUR Duration of Meal Char ISO 8601 Timing Collected duration of the meal represented in ISO 8601 character format. Used only if collected on the CRF and not derived. Perm
SDTMIG 3.3 ML 30 MLTPT Planned Time Point Name Char Timing Text description of time when a measurement or observation should be taken as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point. See MLTPTNUM and MLTPTREF. Perm
SDTMIG 3.3 ML 31 MLTPTNUM Planned Time Point Number Num Timing Numeric version of planned time point used in sorting. Perm
SDTMIG 3.3 ML 32 MLELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Planned Elapsed time (in ISO 8601) relative to the planned fixed reference (MLTPTREF). This variable is useful when there are repetitive measures. Not a clock time or a date/time variable. Represented as an ISO 8601 duration. Perm
SDTMIG 3.3 ML 33 MLTPTREF Time Point Reference Char Timing Description of the fixed reference point referred to by MLELTM, MLTPTNUM, and MLTPT. Perm
SDTMIG 3.3 ML 34 MLRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Date/time for a fixed reference time point defined by MLTPTREF in ISO 8601 character format. Perm
SDTMIG 3.3 ML 35 MIDS Disease Milestone Instance Name Char Timing The name of a specific instance of a Disease Milestone Type (MIDSTYPE) described in the Trial Disease Milestones dataset. This should be unique within a subject. Used only in conjunction with RELMIDS and MIDSDTC. Perm
SDTMIG 3.3 ML 36 RELMIDS Temporal Relation to Milestone Instance Char Timing The temporal relationship of the observation to the Disease Milestone Instance Name in MIDS. Examples: "IMMEDIATELY BEFORE", "AT TIME OF", "AFTER". Perm
SDTMIG 3.3 ML 37 MIDSDTC Disease Milestone Instance Date/Time Char ISO 8601 Timing The start date/time of the Disease Milestone Instance Name in MIDS, in ISO 8601 format. Perm