Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 CE 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 CE 2 DOMAIN Domain Abbreviation Char CE Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 CE 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 CE 4 CESEQ Sequence Number Num Identifier Sequence Number given to ensure uniqueness of subject records within adomain. May be any valid number. Req
SDTMIG 3.3 CE 5 CEGRPID Group ID Char Identifier Used to link together a block of related records for a subject within a domain. Perm
SDTMIG 3.3 CE 6 CEREFID Reference ID Char Identifier Internal or external identifier such as lab specimen ID, or UUID for an ECG waveform or a medical image. Perm
SDTMIG 3.3 CE 7 CESPID Sponsor-Defined Identifier Char Identifier Sponsor-defined identifier. Perm
SDTMIG 3.3 CE 8 CETERM Reported Term for the Clinical Event Char Topic Term for the medical condition or event. Most likely preprinted on CRF. Req
SDTMIG 3.3 CE 9 CEDECOD Dictionary-Derived Term Char Synonym Qualifier 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 external codelist element in the Define-XML document. Perm
SDTMIG 3.3 CE 10 CECAT Category for the Clinical Event Char Grouping Qualifier Used to define a category of related records. Perm
SDTMIG 3.3 CE 11 CESCAT Subcategory for the Clinical Event Char Grouping Qualifier A further categorization of the condition or event. Perm
SDTMIG 3.3 CE 12 CEPRESP Clinical Event Pre-specified Char (NY) Variable Qualifier Used to indicate whether the Event in CETERM was pre-specified. Value is "Y" for pre-specified events and null for spontaneously reported events. Perm
SDTMIG 3.3 CE 13 CEOCCUR Clinical Event Occurrence Char (NY) Record Qualifier 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. Perm
SDTMIG 3.3 CE 14 CESTAT Completion Status Char (ND) Record Qualifier The status indicates that a question from a pre-specified list was not answered. Perm
SDTMIG 3.3 CE 15 CEREASND Reason Clinical Event Not Collected Char Record Qualifier Describes the reason clinical event data was not collected. Used in conjunction with CESTAT when value is "NOT DONE". Perm
SDTMIG 3.3 CE 16 CEBODSYS Body System or Organ Class Char Record Qualifier 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 multiaxial 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. Perm
SDTMIG 3.3 CE 17 CESEV Severity/Intensity Char Record Qualifier The severity or intensity of the event. Examples: "MILD", "MODERATE", "SEVERE". Perm
SDTMIG 3.3 CE 18 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 clinical event started. Perm
SDTMIG 3.3 CE 19 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the start date/time of the clinical event. Perm
SDTMIG 3.3 CE 20 CEDTC Date/Time of Event Collection Char ISO 8601 Timing Collection date and time for the clinical event observation represented in ISO 8601 character format. Perm
SDTMIG 3.3 CE 21 CESTDTC Start Date/Time of Clinical Event Char ISO 8601 Timing Start date/time of the clinical event represented in ISO 8601 character format. Perm
SDTMIG 3.3 CE 22 CEENDTC End Date/Time of Clinical Event Char ISO 8601 Timing End date/time of the clinical event, represented in ISO 8601 character format. Perm
SDTMIG 3.3 CE 23 CEDY Study Day of Event Collection Num Timing 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. Perm
SDTMIG 3.3 CE 24 CESTDY Study Day of Start of Event Num Timing Actual study day of start of the clinical event expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. Perm
SDTMIG 3.3 CE 25 CEENDY Study Day of End of Event Num Timing Actual study day of end of the clinical event expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. Perm
SDTMIG 3.3 CE 26 CESTRF Start Relative to Reference Period Char (STENRF) Timing 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). Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables. Perm
SDTMIG 3.3 CE 27 CEENRF End Relative to Reference Period Char (STENRF) Timing 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). Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables. Perm
SDTMIG 3.3 CE 28 CESTRTPT Start Relative to Reference Time Point Char (STENRF) Timing Identifies the start of the observation as being before or after the reference time point defined by variable CESTTPT. Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables. Perm
SDTMIG 3.3 CE 29 CESTTPT Start Reference Time Point Char Timing 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". Perm
SDTMIG 3.3 CE 30 CEENRTPT End Relative to Reference Time Point Char (STENRF) Timing Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable CEENTPT. Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables. Perm
SDTMIG 3.3 CE 31 CEENTPT End Reference Time Point Char Timing Description or date/time in ISO 8601 character format of the reference point referred to by CEENRTPT. Examples: "2003-12-25" or "VISIT 2". Perm