SDTM.EG

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	EG	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	EG	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	EG	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	EG	SPDEVID	Sponsor Device Identifier	Char		Identifier	Perm	Sponsor-defined identifier for a device.
5	EG	EGSEQ	Sequence Number	Num		Identifier	Req	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
6	EG	EGGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
7	EG	EGREFID	ECG Reference ID	Char		Identifier	Perm	Internal or external ECG identifier. Example: "334PT89".
8	EG	EGSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined reference number. May be printed on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on the ECG page.
9	EG	EGBEATNO	ECG Beat Number	Num		Identifier	Perm	A sequence number that identifies the beat within an ECG.
10	EG	EGTESTCD	ECG Test or Examination Short Name	Char	C71153 C120523	Topic	Req	Short name of the measurement, test, or examination described in EGTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in EGTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). EGTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "PRAG", "QRSAG". \n Test codes are in 2 separate codelists, 1 for tests based on regular 10-second ECGs (EGTESTCD) and one 1 tests based on Holter monitoring (HETESTCD).
11	EG	EGTEST	ECG Test or Examination Name	Char	C71152 C120524	Synonym Qualifier	Req	Verbatim name of the test or examination used to obtain the measurement or finding. The value in EGTEST cannot be longer than 40 characters. Examples: "PR Interval, Aggregate", "QRS Duration, Aggregate". \n Test names are in 2 separate codelists, 1 for tests based on regular 10-second ECGs (EGTEST) and 1 for tests based on Holter monitoring (HETEST).
12	EG	EGCAT	Category for ECG	Char		Grouping Qualifier	Perm	Used to categorize ECG observations across subjects. Examples: "MEASUREMENT", "FINDING", "INTERVAL".
13	EG	EGSCAT	Subcategory for ECG	Char		Grouping Qualifier	Perm	A further categorization of the ECG.
14	EG	EGPOS	ECG Position of Subject	Char	C71148	Record Qualifier	Perm	Position of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING".
15	EG	EGORRES	Result or Finding in Original Units	Char		Result Qualifier	Exp	Result of the ECG measurement or finding as originally received or collected. Examples of expected values are "62" or "0.151" when the result is an interval or measurement, or "ATRIAL FIBRILLATION" or "QT PROLONGATION" when the result is a finding.
16	EG	EGORRESU	Original Units	Char	C71620	Variable Qualifier	Perm	Original units in which the data were collected. The unit for EGORRES. Examples: "sec", "msec".
17	EG	EGSTRESC	Character Result/Finding in Std Format	Char	C71150 C120522 C101834	Result Qualifier	Exp	Contains the result value for all findings copied or derived from EGORRES, in a standard format or standard units. EGSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in EGSTRESN. For example, if a test has results of 62 beats/min, then EGORRES = "62", EGORRESU = "beats/min", EGSTRESC = "62", EGSTRESN = 62, and EGSTRESU = "beats/min" . For other examples, see Original and Standardized Results. Additional examples of result data: "SINUS BRADYCARDIA", "ATRIAL FLUTTER", "ATRIAL FIBRILLATION". \n Test results are in 3 separate codelists: EGSTRESC for abnormal test results based on regular 10-second ECGs; HESTRESC for abnormal test results based on Holter monitoring, and NORMABNM for generic test results and/or responses to EGTEST = "Interpretation".
18	EG	EGSTRESN	Numeric Result/Finding in Standard Units	Num		Result Qualifier	Perm	Used for continuous or numeric results or findings in standard format; copied in numeric format from EGSTRESC. EGSTRESN should store all numeric test results or findings.
19	EG	EGSTRESU	Standard Units	Char	C71620	Variable Qualifier	Perm	Standardized units used for EGSTRESC and EGSTRESN.
20	EG	EGSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate an ECG was not done, or an ECG measurement was not taken. Should be null if a result exists in EGORRES.
21	EG	EGREASND	Reason ECG Not Done	Char		Record Qualifier	Perm	Describes why a measurement or test was not performed. Examples: "BROKEN EQUIPMENT", "SUBJECT REFUSED". Used in conjunction with EGSTAT when value is "NOT DONE".
22	EG	EGXFN	ECG External File Path	Char		Record Qualifier	Perm	File name and path for the external ECG waveform file.
23	EG	EGNAM	Vendor Name	Char		Record Qualifier	Perm	Name or identifier of the laboratory or vendor providing the test results.
24	EG	EGMETHOD	Method of Test or Examination	Char	C71151	Record Qualifier	Perm	Method of the ECG test. Example: "12-LEAD STANDARD".
25	EG	EGLEAD	Lead Location Used for Measurement	Char	C90013	Record Qualifier	Perm	The lead used for the measurement. Examples: "LEAD 1", "LEAD 2", "LEAD rV2", "LEAD V1".
26	EG	EGLOBXFL	Last Observation Before Exposure Flag	Char	C66742	Record Qualifier	Exp	Operationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.
27	EG	EGBLFL	Baseline Flag	Char	C66742	Record Qualifier	Perm	Indicator used to identify a baseline value. Should be "Y" or null. Note that EGBLFL is retained for backward compatibility. The authoritative baseline for statistical analysis is in an ADaM dataset.
28	EG	EGDRVFL	Derived Flag	Char	C66742	Record Qualifier	Perm	Used to indicate a derived record. The value should be "Y" or null. Records that represent the average of other records, or that do not come from the CRF, or are not as originally collected or received are examples of records that would be derived for the submission datasets. If EGDRVFL="Y", then EGORRES could be null, with EGSTRESC and EGSTRESN (if the result is numeric) having the derived value.
29	EG	EGEVAL	Evaluator	Char	C78735	Record Qualifier	Perm	Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain collected or derived data. Examples: "INVESTIGATOR", "ADJUDICATION COMMITTEE", "VENDOR".
30	EG	EGEVALID	Evaluator Identifier	Char	C96777	Variable Qualifier	Perm	Used to distinguish multiple evaluators with the same role recorded in EGEVAL. Examples: "RADIOLOGIST 1" or "RADIOLOGIST 2".
31	EG	EGCLSIG	Clinically Significant, Collected	Char	C66742	Record Qualifier	Perm	Used to indicate whether a collected observation is clinically significant based on judgment.
32	EG	EGREPNUM	Repetition Number	Num		Record Qualifier	Perm	The incidence number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a time point, within a visit). Examples: multiple measurements of blood pressure, multiple analyses of a sample.
33	EG	VISITNUM	Visit Number	Num		Timing	Exp	Clinical encounter number. Numeric version of VISIT, used for sorting.
34	EG	VISIT	Visit Name	Char		Timing	Perm	Protocol-defined description of clinical encounter. May be used in addition to VISITNUM and/or VISITDY.
35	EG	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
36	EG	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 assessment was made.
37	EG	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the date/time at which the assessment was made.
38	EG	EGDTC	Date/Time of ECG	Char	ISO 8601 datetime or interval	Timing	Exp	Date/Time of ECG.
39	EG	EGDY	Study Day of ECG	Num		Timing	Perm	Study day of the ECG, measured as integer days. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.
40	EG	EGTPT	Planned Time Point Name	Char		Timing	Perm	Text description of time when measurement should be taken. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See EGTPTNUM and EGTPTREF. Examples: "Start", "5 min post".
41	EG	EGTPTNUM	Planned Time Point Number	Num		Timing	Perm	Numerical version of EGTPT to aid in sorting.
42	EG	EGELTM	Planned Elapsed Time from Time Point Ref	Char	ISO 8601 duration	Timing	Perm	Planned elapsed time (in ISO 8601) relative to a fixed time point reference (EGTPTREF). Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by EGTPTREF, "PT8H" to represent the period of 8 hours after the reference point indicated by EGTPTREF.
43	EG	EGTPTREF	Time Point Reference	Char		Timing	Perm	Name of the fixed reference point referred to by EGELTM, EGTPTNUM, and EGTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".
44	EG	EGRFTDTC	Date/Time of Reference Time Point	Char	ISO 8601 datetime or interval	Timing	Perm	Date/time for a fixed reference time point defined by EGTPTREF.