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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 adomain. May be any valid number.
5 CE CEGRPID Group ID Char Identifier Perm Used to link together a block of related records for a subject within a domain.
6 CE CEREFID Reference ID Char Identifier Perm Internal or external identifier such as lab specimen ID, or UUID for an ECG waveform or a medical image.
7 CE CESPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined identifier.
8 CE CETERM Reported Term for the Clinical Event Char Topic Req Term for the medical condition or event. Most likely preprinted 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 external codelist element in the Define-XML document.
10 CE CECAT Category for the Clinical Event Char Grouping Qualifier Perm Used to define a category of related records.
11 CE CESCAT Subcategory for the 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 and 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 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.
17 CE CESEV Severity/Intensity Char Record Qualifier Perm The severity or intensity of the event. Examples: "MILD", "MODERATE", "SEVERE".
18 CE 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 clinical event started.
19 CE EPOCH Epoch Char C99079 Timing Perm Epoch associated with the start date/time of the clinical event.
20 CE CEDTC Date/Time of Event Collection Char ISO 8601 Timing Perm Collection date and time for the clinical event observation represented in ISO 8601 character format.
21 CE CESTDTC Start Date/Time of Clinical Event Char ISO 8601 Timing Perm Start date/time of the clinical event represented in ISO 8601 character format.
22 CE CEENDTC End Date/Time of Clinical Event Char ISO 8601 Timing Perm End date/time of the clinical event, represented in ISO 8601 character format.
23 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.
24 CE CESTDY Study Day of Start of Event Num Timing Perm Actual study day of start of the clinical event expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
25 CE CEENDY Study Day of End of Event Num Timing Perm Actual study day of end of the clinical event expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
26 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). Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.
27 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). Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.
28 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. Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.
29 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".
30 CE CEENRTPT End Relative to Reference Time Point Char C66728 Timing Perm 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.
31 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".