SDTM.EX

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	EX	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	EX	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	EX	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	EX	EXSEQ	Sequence Number	Num		Identifier	Req	Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	EX	EXGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
6	EX	EXREFID	Reference ID	Char		Identifier	Perm	Internal or external identifier (e.g., kit number, bottle label, vial identifier).
7	EX	EXSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	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 CRF Page.
8	EX	EXLNKID	Link ID	Char		Identifier	Perm	Identifier used to link related records across domains.
9	EX	EXLNKGRP	Link Group ID	Char		Identifier	Perm	Identifier used to link related, grouped records across domains.
10	EX	EXTRT	Name of Treatment	Char		Topic	Req	Name of the protocol-specified study treatment given during the dosing period for the observation.
11	EX	EXCAT	Category of Treatment	Char		Grouping Qualifier	Perm	Used to define a category of EXTRT values.
12	EX	EXSCAT	Subcategory of Treatment	Char		Grouping Qualifier	Perm	A further categorization of EXCAT values.
13	EX	EXDOSE	Dose	Num		Record Qualifier	Exp	Amount of EXTRT when numeric. Not populated when EXDOSTXT is populated.
14	EX	EXDOSTXT	Dose Description	Char		Record Qualifier	Perm	Amount of EXTRT when non-numeric. Dosing amounts or a range of dosing information collected in text form. Example: 200-400. Not populated when EXDOSE is populated.
15	EX	EXDOSU	Dose Units	Char	C71620	Variable Qualifier	Exp	Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified values. Examples: ng, mg, mg/kg, mg/m2.
16	EX	EXDOSFRM	Dose Form	Char	C66726	Variable Qualifier	Exp	Dose form for EXTRT. Examples: TABLET, LOTION.
17	EX	EXDOSFRQ	Dosing Frequency per Interval	Char	C71113	Variable Qualifier	Perm	Usually expressed as the number of repeated administrations of EXDOSE within a specific time period. Examples: Q2H, QD, BID.
18	EX	EXDOSRGM	Intended Dose Regimen	Char		Variable Qualifier	Perm	Text description of the intended schedule or regimen for the Intervention. Example: TWO WEEKS ON, TWO WEEKS OFF.
19	EX	EXROUTE	Route of Administration	Char	C66729	Variable Qualifier	Perm	Route of administration for the intervention. Examples: ORAL, INTRAVENOUS.
20	EX	EXLOT	Lot Number	Char		Record Qualifier	Perm	Lot Number of the intervention product.
21	EX	EXLOC	Location of Dose Administration	Char	C74456	Record Qualifier	Perm	Specifies location of administration. Examples: ARM, LIP.
22	EX	EXLAT	Laterality	Char	C99073	Variable Qualifier	Perm	Qualifier for anatomical location further detailing laterality of the intervention administration. Examples: LEFT, RIGHT.
23	EX	EXDIR	Directionality	Char	C99074	Variable Qualifier	Perm	Qualifier for anatomical location further detailing directionality. Examples: ANTERIOR, LOWER, PROXIMAL, UPPER.
24	EX	EXFAST	Fasting Status	Char	C66742	Record Qualifier	Perm	Indicator used to identify fasting status. Examples: Y, N.
25	EX	EXADJ	Reason for Dose Adjustment	Char		Record Qualifier	Perm	Describes reason or explanation of why a dose is adjusted.
26	EX	EPOCH	Epoch	Char	C99079	Timing	Perm	Trial Epoch of the Exposure record. Examples: RUN-IN, TREATMENT.
27	EX	EXSTDTC	Start Date/Time of Treatment	Char	ISO 8601	Timing	Exp	The date/time when administration of the treatment indicated by EXTRT and EXDOSE began.
28	EX	EXENDTC	End Date/Time of Treatment	Char	ISO 8601	Timing	Exp	The date/time when administration of the treatment indicated by EXTRT and EXDOSE 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, EXSTDTC should be copied to EXENDTC as the standard representation.
29	EX	EXSTDY	Study Day of Start of Treatment	Num		Timing	Perm	Study day of EXSTDTC relative to DM.RFSTDTC.
30	EX	EXENDY	Study Day of End of Treatment	Num		Timing	Perm	Study day of EXENDTC relative to DM.RFSTDTC.
31	EX	EXDUR	Duration of Treatment	Char	ISO 8601	Timing	Perm	Collected duration of administration represented in ISO 8601 duration format. Used only if collected on the CRF and not derived from start and end date/times.
32	EX	EXTPT	Planned Time Point Name	Char		Timing	Perm	1. Text Description of time when administration should occur. 2. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See EXTPTNUM and EXTPTREF.
33	EX	EXTPTNUM	Planned Time Point Number	Num		Timing	Perm	Numerical version of EXTPT to aid in sorting.
34	EX	EXELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601	Timing	Perm	Planned elapsed time (in ISO 8601 format) relative to the planned fixed reference (EXTPTREF). This variable is useful where there are repetitive measures. Not a clock time. Represented in ISO 8601 duration format.
35	EX	EXTPTREF	Time Point Reference	Char		Timing	Perm	Name of the fixed reference point referred to by EXELTM, EXTPTNUM, and EXTPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL.
36	EX	EXRFTDTC	Date/Time of Reference Time Point	Char	ISO 8601	Timing	Perm	Date/time for a fixed reference time point defined by EXTPTREF in ISO 8601 character format.