| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
| DOMAIN | Domain Abbreviation | Char | EG | Identifier | Two-character abbreviation for the domain. | Req |
| 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 |
| SPDEVID | Applicant Device Identifier | Char |
| Identifier | Applicant-defined identifier for a device. | Perm |
| EGSEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req |
| EGGRPID | Group ID | Char |
| Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm |
| EGREFID | ECG Reference ID | Char |
| Identifier | Internal or external ECG identifier. Example: "UUID". |
Perm |
| EGSPID | Applicant-Defined Identifier | Char |
| Identifier | Applicant-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number from the ECG page. | Perm |
| EGBEATNO | ECG Beat Number | Num |
| Variable Qualifier | A sequence number that identifies the beat within an ECG. | Perm |
| EGTESTCD | ECG Test or Examination Short Name | Char | (EGTESTCD)
(HETESTCD) | Topic | 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". Test codes are in two separate codelists, one for tests based on regular 10-second ECGs (EGTESTCD) and one for tests based on Holter monitoring (HETESTCD). | Req |
| EGTEST | ECG Test or Examination Name | Char | (EGTEST)
(HETEST) | Synonym Qualifier | 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". Test names are in two separate codelists, one for tests based on regular 10-second ECGs (EGTEST) and one for tests based on Holter monitoring (HETEST). | Req |
| EGCAT | Category for ECG | Char |
| Grouping Qualifier | Used to categorize ECG observations across subjects. Examples: "MEASUREMENT", "FINDING", "INTERVAL". | Perm |
| EGSCAT | Subcategory for ECG | Char |
| Grouping Qualifier | A further categorization of the ECG. | Perm |
| EGPOS | ECG Position of Subject | Char | (POSITION) | Record Qualifier | Position of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING". | Perm |
| EGORRES | Result or Finding in Original Units | Char |
| Result Qualifier | 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. | Exp |
| EGORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. The unit for EGORRES. Examples: "sec" or "msec". | Perm |
| EGSTRESC | Character Result/Finding in Std Format | Char | (EGSTRESC)
(HESTRESC) | Result Qualifier | 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 "NONE", "NEG", and "NEGATIVE" in EGORRES and these results effectively have the same meaning, they could be represented in standard format in EGSTRESC as "NEGATIVE". For other examples, see general assumptions. Additional examples of result data: "SINUS BRADYCARDIA", "ATRIAL FLUTTER", "ATRIAL FIBRILLATION". Test results are in two separate codelists, one for tests based on regular 10-second ECGs (EGSTRESC) and one for tests based on Holter monitoring (HESTRESC). | Exp |
| EGSTRESN | Numeric Result/Finding in Standard Units | Num |
| Result Qualifier | 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. | Perm |
| EGSTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized units used for EGSTRESC and EGSTRESN. | Perm |
| EGSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate an ECG was not done, or an ECG measurement was not taken. Should be null if a result exists in EGORRES. | Perm |
| EGREASND | Reason ECG Not Done | Char |
| Record Qualifier | Describes why a measurement or test was not performed. Examples: "BROKEN EQUIPMENT" or "SUBJECT REFUSED". Used in conjunction with EGSTAT when value is "NOT DONE". | Perm |
| EGXFN | ECG External File Path | Char |
| Record Qualifier | File name and path for the external ECG waveform file. | Perm |
| EGNAM | Vendor Name | Char |
| Record Qualifier | Name or identifier of the laboratory or vendor who provided the test results. | Perm |
| EGMETHOD | Method of Test or Examination | Char | (EGMETHOD) | Record Qualifier | Method of the ECG test. Example: "12 LEAD STANDARD". | Perm |
| EGLEAD | Lead Location Used for Measurement | Char | (EGLEAD) | Record Qualifier | The lead used for the measurement. Examples: "LEAD 1", "LEAD 2", "LEAD 3", "LEAD rV2", "LEAD V1". | Perm |
| EGLOBXFL | Last Observation Before Exposure Flag | Char | (NY) | Record Qualifier | Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null. | Exp |
| EGEVAL | Evaluator | Char | (EVAL) | Record Qualifier | 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". | Perm |
| EGEVALID | Evaluator Identifier | Char | (MEDEVAL) | Variable Qualifier | Used to distinguish multiple evaluators with the same role recorded in EGEVAL. Examples: "RADIOLOGIST 1" or "RADIOLOGIST 2". | Perm |
| EGREPNUM | Repetition Number | Num |
| Record Qualifier | 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 or within a visit. For example, multiple measurements of blood pressure or multiple analyses of a sample. | Perm |
| VISITNUM | Visit Number | Num |
| Timing | - Clinical encounter numberAn assigned numeric identifier that aligns to the chronological order of an encounter.
- Numeric version of VISIT, used for sorting.
| Exp |
| VISIT | Visit Name | Char |
| Timing | - Protocol-defined description of clinical encounter.
- May be used in addition to VISITNUM and/or VISITDY.
| Perm |
| VISITDY | Planned Study Day of Visit | Num |
| Timing | Planned study day of the visit based upon RFSTDTC in Demographics. | Perm |
| 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 assessment was made. | Perm |
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the date/time at which the assessment was made. | Perm |
| EGDTC | Date/Time of ECG | Char | ISO 8601 datetime or interval | Timing | Date/Time of ECG. | Exp |
| EGDY | Study Day of ECG | Num |
| Timing | - Study day of the ECG, measured as integer days.
- Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics.
| Perm |
| EGTPT | Planned Time Point Name | Char |
| Timing | - 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".
| Perm |
| EGTPTNUM | Planned Time Point Number | Num |
| Timing | Numerical version of EGTPT to aid in sorting. | Perm |
| EGELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | 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, or "PT8H" to represent the period of 8 hours after the reference point indicated by EGTPTREF. | Perm |
| EGTPTREF | Time Point Reference | Char |
| Timing | Name of the fixed reference point referred to by EGELTM, EGTPTNUM, and EGTPT. | Perm |
| EGRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/time for a fixed reference time point defined by EGTPTREF. | Perm |