| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
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 |
Sponsor Device Identifier |
Char |
Identifier |
Sponsor-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 |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor-defined reference number. Perhaps preprinted on the
CRF as an explicit line identifier or defined in the sponsor's
operational database. Example: Line number from the ECG page. |
Perm |
| EGTESTCD |
ECG Test or Examination Short Name |
Char |
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 |
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 |
Record Qualifier |
Position of the subject during a measurement or examination.
Examples: "SUPINE", "STANDING", "SITTING". |
Perm |
| EGBEATNO |
ECG Beat Number |
Num |
Variable Qualifier |
A sequence number that identifies the beat within an ECG. |
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 |
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 |
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 |
Variable Qualifier |
Standardized units used for EGSTRESC and EGSTRESN. |
Perm |
| EGSTAT |
Completion Status |
Char |
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 |
Record Qualifier |
Method of the ECG test. Example: "12 LEAD STANDARD". |
Perm |
| EGLEAD |
Lead Location Used for Measurement |
Char |
Record Qualifier |
The lead used for the measurement. Examples: "LEAD 1", "LEAD
2", "LEAD 3", "LEAD rV2", "LEAD V1". |
Perm |
| EGLOBXFL |
Last Observation |
Char |
Record Qualifier |
Operationally-derived indicator used to identify the last
non-missing value prior to |
Exp |
| |
Before Exposure Flag |
|
|
RFXSTDTC. The value should be "Y" or null. |
|
| EGBLFL |
Baseline Flag |
Char |
Record Qualifier |
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. |
Perm |
| EGDRVFL |
Derived Flag |
Char |
Record Qualifier |
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. |
Perm |
| EGEVAL |
Evaluator |
Char |
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 |
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 number. 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 |
Timing |
Epoch associated with the date/time at which the assessment
was made. |
Perm |
| EGDTC |
Date/Time of ECG |
Char |
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 sponsor-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 |
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. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL". |
Perm |
| EGRFTDTC |
Date/Time of Reference Time Point |
Char |
Timing |
Date/time for a fixed reference time point defined by
EGTPTREF. |
Perm |