SDTM.ML

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	ML	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	ML	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	ML	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	ML	MLSEQ	Sequence Number	Num		Identifier	Req	Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	ML	MLGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
6	ML	MLSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	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.
7	ML	MLTRT	Name of Meal	Char		Topic	Req	Verbatim food product name that is either pre-printed or collected on a CRF.
8	ML	MLCAT	Category for Meal	Char		Grouping Qualifier	Perm	Used to define a category of MLTRT values.
9	ML	MLSCAT	Subcategory for Meal	Char		Grouping Qualifier	Perm	Used to define a further categorization of MLCAT values.
10	ML	MLPRESP	ML Pre-specified	Char	C66742	Variable Qualifier	Perm	Used when a specific meal is pre-specified on a CRF. Values should be "Y" or null.
11	ML	MLOCCUR	ML Occurrence	Char	C66742	Record Qualifier	Perm	Used to record whether a pre-specified meal occurred when information about the occurrence of a specific meal is solicited.
12	ML	MLSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	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".
13	ML	MLREASND	Reason Meal Not Collected	Char		Record Qualifier	Perm	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".
14	ML	MLDOSE	Dose	Num		Record Qualifier	Perm	Amount of MLTRT consumed. Not populated when MLDOSTXT is populated.
15	ML	MLDOSTXT	Dose Description	Char		Record Qualifier	Perm	Amount description of MLTRT consumed, collected in text form. Not populated when MLDOSE is populated. Examples: "<1 per day", "200-400".
16	ML	MLDOSU	Dose Units	Char	C71620	Variable Qualifier	Perm	Units for MLDOSE, MLDOSTOT, or MLDOSTXT.
17	ML	MLDOSFRM	Dose Form	Char	C66726	Variable Qualifier	Perm	Dosage form for MLTRT. Example: "BAR, CHEWABLE".
18	ML	VISITNUM	Visit Number	Num		Timing	Perm	Clinical encounter number. Numeric version of VISIT, used for sorting.
19	ML	VISIT	Visit Name	Char		Timing	Perm	Protocol-defined description of a clinical encounter.
20	ML	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of VISIT. Should be an integer.
21	ML	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	Number that gives the planned order of the Element within the Arm for the Element in which the meal started.
22	ML	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the start date/time of the meal.
23	ML	MLDTC	Date/Time of Collection	Char	ISO 8601	Timing	Perm	Collection date and time of the meal represented in ISO 8601 character format.
24	ML	MLSTDTC	Start Date/Time of Meal	Char	ISO 8601	Timing	Perm	Start date/time of the meal represented in ISO 8601 character format.
25	ML	MLENDTC	End Date/Time of Meal	Char	ISO 8601	Timing	Perm	End date/time of the meal represented in ISO 8601 character format.
26	ML	MLDY	Study Day of Visit/Collection/Exam	Num		Timing	Perm	Actual study day of the visit/collection expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
27	ML	MLSTDY	Study Day of Start of Meal	Num		Timing	Perm	Actual study day of start of the meal expressed in integer days relative to sponsor-defined RFSTDTC in Demographics.
28	ML	MLENDY	Study Day of End of Meal	Num		Timing	Perm	Actual study day of end of the meal expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
29	ML	MLDUR	Duration of Meal	Char	ISO 8601	Timing	Perm	Collected duration of the meal represented in ISO 8601 character format. Used only if collected on the CRF and not derived.
30	ML	MLTPT	Planned Time Point Name	Char		Timing	Perm	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.
31	ML	MLTPTNUM	Planned Time Point Number	Num		Timing	Perm	Numeric version of planned time point used in sorting.
32	ML	MLELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601	Timing	Perm	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.
33	ML	MLTPTREF	Time Point Reference	Char		Timing	Perm	Description of the fixed reference point referred to by MLELTM, MLTPTNUM, and MLTPT.
34	ML	MLRFTDTC	Date/Time of Reference Time Point	Char	ISO 8601	Timing	Perm	Date/time for a fixed reference time point defined by MLTPTREF in ISO 8601 character format.
35	ML	MIDS	Disease Milestone Instance Name	Char		Timing	Perm	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.
36	ML	RELMIDS	Temporal Relation to Milestone Instance	Char		Timing	Perm	The temporal relationship of the observation to the Disease Milestone Instance Name in MIDS. Examples: "IMMEDIATELY BEFORE", "AT TIME OF", "AFTER".
37	ML	MIDSDTC	Disease Milestone Instance Date/Time	Char	ISO 8601	Timing	Perm	The start date/time of the Disease Milestone Instance Name in MIDS, in ISO 8601 format.