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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 EGSEQ Sequence Number Num Identifier Req Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
5 EG EGGRPID Group ID Char Identifier Perm Used to tie together a block of related records in a single domain for a subject.
6 EG EGREFID ECG Reference ID Char Identifier Perm Internal or external ECG identifier. Example: UUID.
7 EG EGSPID 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 from the ECG page.
8 EG EGTESTCD ECG Test or Examination Short Name Char C71153 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"). EGTESTCD cannot contain characters other than letters, numbers, or underscores. Examples :PRMEAN, QTMEAN
9 EG EGTEST ECG Test or Examination Name Char C71152 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: Summary (Mean) PR Duration, Summary (Mean) QT Duration
10 EG EGCAT Category for ECG Char Grouping Qualifier Perm Used to categorize ECG observations across subjects. Examples: MEASUREMENT, FINDING, INTERVAL
11 EG EGSCAT Subcategory for ECG Char Grouping Qualifier Perm A further categorization of the ECG.
12 EG EGPOS ECG Position of Subject Char C71148 Record Qualifier Perm Position of the subject during a measurement or examination. Examples: SUPINE, STANDING, SITTING.
13 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.
14 EG EGORRESU Original Units Char C71620 Variable Qualifier Perm Original units in which the data were collected. The unit for EGORRES. Examples: sec or msec.
15 EG EGSTRESC Character Result/Finding in Std Format Char C71150 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 "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.
16 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.
17 EG EGSTRESU Standard Units Char C71620 Variable Qualifier Perm Standardized unit used for EGSTRESC or EGSTRESN.
18 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.
19 EG EGREASND Reason ECG Not Performed Char Record Qualifier Perm 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.
20 EG EGXFN ECG External File Path Char Record Qualifier Perm File name and path for the external ECG Waveform file.
21 EG EGNAM Vendor Name Char Record Qualifier Perm Name or identifier of the laboratory or vendor who provided the test results.
22 EG EGLEAD Lead Location Used for Measurement Char C74456 Record Qualifier Perm The lead used for the measurement, examples, V1, V6, aVR, I, II, III.
23 EG EGMETHOD Method of ECG Test Char C71151 Record Qualifier Perm Method of the ECG test. Examples: 12 LEAD STANDARD.
24 EG EGBLFL Baseline Flag Char C66742 Record Qualifier Exp Indicator used to identify a baseline value. The value should be "Y" or null.
25 EG EGDRVFL Derived Flag Char C66742 Record Qualifier Perm Used to indicate a derived record. The value should be Y or null. Records which 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 (if numeric) EGSTRESN having the derived value.
26 EG EGEVAL Evaluator Char 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.
27 EG VISITNUM Visit Number Num Timing Exp 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
28 EG VISIT Visit Name Char Timing Perm 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
29 EG VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of the visit based upon RFSTDTC in Demographics.
30 EG EGDTC Date/Time of ECG Char ISO 8601 Timing Exp Date of ECG.
31 EG EGDY Study Day of ECG Num Timing Perm 1. Study day of the ECG, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.
32 EG EGTPT Planned Time Point Name Char Timing Perm 1. Text Description of time when measurement should be taken. 2. 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.
33 EG EGTPTNUM Planned Time Point Number Num Timing Perm Numerical version of EGTPT to aid in sorting.
34 EG EGELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 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, or "PT8H" to represent the period of 8 hours after the reference point indicated by EGTPTREF.
35 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.
36 EG EGRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm Date/time of the reference time point, EGTPTREF.