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Findings Specifications 

EG Specification

Created by Chris Gemma, last modified by Diane Wold on Oct 11,
2017

 SDTMIG v3.3 Metadata Check for Domain Specification Table 1.2.2

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the
specification table. An FAQ is available to aid troubleshooting.
Release Notes

Variable Variable Type Controlled Role CDISC Notes Core

Name Label Terms,
Codelist or
Format
STUDYID Study Char   Identifier Unique identifier for a study. Req
Identifier
DOMAIN Domain Char EG Identifier Two-character abbreviation for the Req
Abbreviation domain.
USUBJID Unique Char   Identifier Identifier used to uniquely identify a Req
Subject subject across all studies for all
Identifier applications or submissions
involving the product.
SPDEVID Sponsor Char   Identifier Sponsor-defined identifier for a Perm
Device device.
Identifier
EGSEQ Sequence Num   Identifier Sequence Number given to ensure Req
Number uniqueness of subject records
within a domain. May be any valid
number.
EGGRPID Group ID Char   Identifier Used to tie together a block of Perm
related records in a single domain
for a subject.
EGREFID ECG Char   Identifier Internal or external ECG identifier.
Reference ID Example: "UUID". Perm
EGSPID Sponsor- Char   Identifier Sponsor-defined reference number. Perm
Defined Perhaps pre-printed on the CRF as
Identifier an explicit line identifier or defined
in the sponsor's operational
database. Example: Line number
from the ECG page.
EGTESTCD ECG Test or Char (EGTESTCD) Topic Short name of the measurement, Req
Examination test, or examination described in
 Short Name
(HETESTCD)
EGTEST. It can be used as a
column name when converting a
dataset from a vertical to a

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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 : "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).
EGTEST ECG Test or Char (EGTEST) Synonym Verbatim name of the test or Req
Examination Qualifier examination used to obtain the
(HETEST)
Name 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).
EGCAT Category for Char * Grouping Used to categorize ECG Perm
ECG Qualifier observations across subjects.
Examples: "MEASUREMENT",
"FINDING", "INTERVAL".
EGSCAT Subcategory Char * Grouping A further categorization of the ECG. Perm
for ECG Qualifier
EGPOS ECG Position Char (POSITION) Record Position of the subject during a Perm
of Subject Qualifier measurement or examination.
Examples: "SUPINE",
"STANDING", "SITTING".
EGBEATNO ECG Beat Num   Variable A sequence number that identifies Perm
Number Qualifier the beat within an ECG.
EGORRES Result or Char   Result Result of the ECG measurement or Exp
Finding in Qualifier finding as originally received or
Original Units 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.
EGORRESU Original Units Char (UNIT) Variable Original units in which the data Perm
Qualifier were collected. The unit for
EGORRES. Examples: "sec" or
"msec".
EGSTRESC Character Char (EGSTRESC) Result Contains the result value for all Exp

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Result/Finding Qualifier findings, copied or derived from

(HESTRESC)
in Std Format 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).
EGSTRESN Numeric Num   Result Used for continuous or numeric Perm
Result/Finding Qualifier results or findings in standard
in Standard format; copied in numeric format
Units from EGSTRESC. EGSTRESN
should store all numeric test results
or findings.
EGSTRESU Standard Char (UNIT) Variable Standardized units used for Perm
Units Qualifier EGSTRESC and EGSTRESN.
EGSTAT Completion Char (ND) Record Used to indicate an ECG was not Perm
Status Qualifier done, or an ECG measurement
was not taken. Should be null if a
result exists in EGORRES.
EGREASND Reason ECG Char   Record Describes why a measurement or Perm
Not Done Qualifier test was not performed. Examples:
"BROKEN EQUIPMENT" or
"SUBJECT REFUSED". Used in
conjunction with EGSTAT when
value is "NOT DONE".
EGXFN ECG External Char   Record File name and path for the external Perm
File Path Qualifier ECG waveform file.
EGNAM Vendor Name Char   Record Name or identifier of the laboratory Perm
Qualifier or vendor who provided the test
results.
EGMETHOD Method of Char (EGMETHOD) Record Method of the ECG test. Examples: Perm
Test or Qualifier 12 LEAD STANDARD.
Examination
EGLEAD Lead Location Char (EGLEAD) Record The lead used for the Perm

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Used for Qualifier measurement. Examples: "LEAD

Measurement 1", "LEAD 2", "LEAD 3", "LEAD
rV2", "LEAD V1".
EGLOBXFL Last Char (NY) Record Operationally-derived indicator Exp
Observation Qualifier used to identify the last non-
Before missing value prior to RFXSTDTC.
Exposure The value should be "Y" or null.
Flag
EGBLFL Baseline Flag Char (NY) Record Indicator used to identify a baseline Perm
Qualifier 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.
EGDRVFL Derived Flag Char (NY) Record Used to indicate a derived record. Perm
Qualifier 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 EGSTRESN (if
the result is numeric) having the
derived value.
EGEVAL Evaluator Char (EVAL) Record Role of the person who provided Perm
Qualifier 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".
EGEVALID Evaluator Char (MEDEVAL) Variable Used to distinguish multiple Perm
Identifier Qualifier evaluators with the same role
recorded in EGEVAL. Examples:
"RADIOLOGIST 1" or
"RADIOLOGIST 2".
EGREPNUM Repetition Num   Record The incidence number of a test that Perm
Number Qualifier 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.
VISITNUM Visit Number Num   Timing 1. Clinical encounter number. 2. Exp
Numeric version of VISIT, used for
sorting. .
VISIT Visit Name Char   Timing 1. Protocol-defined description of Perm

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clinical encounter. 2. May be used

in addition to VISITNUM and/or
VISITDY.
VISITDY Planned Num   Timing Planned study day of the visit Perm
Study Day of based upon RFSTDTC in
Visit Demographics.
TAETORD Planned Num   Timing Number that gives the planned Perm
Order of order of the Element within the Arm
Element for the element in which the
within Arm assessment was made.
EPOCH Epoch Char (EPOCH) Timing Epoch associated with the Perm
date/time at which the assessment
was made.
EGDTC Date/Time of Char ISO 8601 Timing Date/Time of ECG. Exp
ECG
EGDY Study Day of Num   Timing 1. Study day of the ECG, measured Perm
ECG as integer days. 2. Algorithm for
calculations must be relative to the
sponsor-defined RFSTDTC
variable in Demographics.
EGTPT Planned Time Char   Timing 1. Text Description of time when Perm
Point Name 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".
EGTPTNUM Planned Time Num   Timing Numerical version of EGTPT to aid Perm
Point Number in sorting.
EGELTM Planned Char ISO 8601 Timing Planned elapsed time (in ISO 8601) Perm
Elapsed Time relative to a fixed time point
from Time reference (EGTPTREF). Not a
Point Ref 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.
EGTPTREF Time Point Char   Timing Name of the fixed reference point Perm
Reference referred to by EGELTM,
EGTPTNUM, and EGTPT.
Examples: "PREVIOUS DOSE",
"PREVIOUS MEAL".
EGRFTDTC Date/Time of Char ISO 8601 Timing Date/time for a fixed reference time Perm
Reference point defined by EGTPTREF.
Time Point

 Metadata Checks Findings

SDTMIG v3.3 Metadata Check User Macros FAQ

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EG Specification - SDTM Implementation Guide 3.3 - CDISC Wiki

Structure: Mismatch column 4 label: Controlled Terms, Codelist or Format (seen) vs.
Controlled Terms, Codelist or Format1 (expected)
Notice: Checks for table content are suspended due to structrual issues reported above.
Content checks will resume after all structural issues are resolved

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