SDTM.CE

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	CE	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	CE	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	CE	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	CE	CESEQ	Sequence Number	Num		Identifier	Req	Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	CE	CEGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records for a subject within a domain.
6	CE	CEREFID	Reference ID	Char		Identifier	Perm	Internal or external identifier.
7	CE	CESPID	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	CE	CETERM	Reported Term for the Clinical Event	Char		Topic	Req	Term for the medical condition or event. Most likely pre-printed on CRF.
9	CE	CEDECOD	Dictionary-Derived Term	Char		Synonym Qualifier	Perm	Controlled terminology for the name of the clinical event. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the define.xml external codelist attributes
10	CE	CECAT	Category for Clinical Event	Char		Grouping Qualifier	Perm	Used to define a category of related records.
11	CE	CESCAT	Subcategory for Clinical Event	Char		Grouping Qualifier	Perm	A further categorization of the condition or event.
12	CE	CEPRESP	Clinical Event Pre-Specified	Char	C66742	Variable Qualifier	Perm	Used to indicate whether the Event in CETERM was pre-specified. Value is Y for pre-specified events, null for spontaneously reported events.
13	CE	CEOCCUR	Clinical Event Occurrence	Char	C66742	Record Qualifier	Perm	Used when the occurrence of specific events is solicited to indicate whether or not a clinical event occurred. Values are null for spontaneously reported events.
14	CE	CESTAT	Completion Status	Char	C66789	Record Qualifier	Perm	The status indicates that a question from a pre-specified list was not answered.
15	CE	CEREASND	Reason Clinical Event Not Collected	Char		Record Qualifier	Perm	Describes the reason clinical event data was not collected. Used in conjunction with CESTAT when value is NOT DONE.
16	CE	CEBODSYS	Body System or Organ Class	Char		Record Qualifier	Perm	Dictionary-derived. Body system or organ class that is involved in an event or measurement from a standard hierarchy (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the sponsor's analyses and summary tables which may not necessarily be the primary SOC.
17	CE	CESEV	Severity/Intensity	Char		Record Qualifier	Perm	The severity or intensity of the event. Examples: MILD, MODERATE, SEVERE
18	CE	CEDTC	Date/Time of Event Collection	Char	ISO 8601	Timing	Perm
19	CE	CESTDTC	Start Date/Time of Clinical Event	Char	ISO 8601	Timing	Perm
20	CE	CEENDTC	End Date/Time of Clinical Event	Char	ISO 8601	Timing	Perm
21	CE	CEDY	Study Day of Event Collection	Num		Timing	Perm	1. Study day of clinical event collection, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission.
22	CE	CESTRF	Start Relative to Reference Period	Char	C66728	Timing	Perm	Describes the start of the clinical event relative to the sponsor-defined reference period. The sponsor-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).
23	CE	CEENRF	End Relative to Reference Period	Char	C66728	Timing	Perm	Describes the end of the event relative to the sponsor-defined reference period. The sponsor-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).
24	CE	CESTRTPT	Start Relative to Reference Time Point	Char	C66728	Timing	Perm	Identifies the start of the observation as being before or after the reference time point defined by variable CESTTPT.
25	CE	CESTTPT	Start Reference Time Point	Char		Timing	Perm	Description or date/time in ISO 8601 character format of the sponsor-defined reference point referred to by --STRTPT. Examples: "2003-12-15" or "VISIT 1".
26	CE	CEENRTPT	End Relative to Reference Time Point	Char	C66728	Timing	Perm	Identifies the end of the event as being before or after the reference time point defined by variable CEENTPT.
27	CE	CEENTPT	End Reference Time Point	Char		Timing	Perm	Description or date/time in ISO 8601 character format of the reference point referred to by CEENRTPT. Examples: "2003-12-25" or "VISIT 2".