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TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1
Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes
| 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 | |
| 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 Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the product group number. | Perm | |
| EGREFID | ECG Reference Identifier | Char | Identifier | Internal or external ECG identifier. Example: UUID. | Perm | |
| EGSPID | Applicant-Defined Identifier | Char | Identifier | Applicant-defined reference identifier. | Perm | |
| EGTESTCD | ECG Test Short Name | Char | (EGTESTCD) | 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: EGHRMN, QTMAX. | Req |
| EGTEST | ECG Test Name | Char | (EGTEST) | Synonym Qualifier | Long name for EGTESTCD. The value in EGTEST cannot be longer than 40 characters. Examples: ECG Mean Heart Rate, Summary (Max) QT Duration. | Req |
| EGCAT | Category for ECG | Char | (EGCATSND) | Grouping Qualifier | Used to define a category of the ECG test performed. Examples: MEASUREMENT, DIAGNOSIS, INTERPRETATION. | Perm |
| EGPOS | ECG Position of Subject | Char | (POSITION) | Record Qualifier | Position of the subject during a measurement or examination. If the subject is restrained, populate with the position (example SITTING or STANDING); otherwise, populate with UNCONSTRAINED. | Exp |
| EGORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the ECG measurement or finding as originally received or collected. | Exp | |
| EGORRESU | Unit of the Original Result | Char | (UNIT) | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp |
| EGSTRESC | Standardized Result in Character Format | Char | (EGSTRESC) | 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, using controlled terminology, where possible. If results are numeric, they should also be stored in numeric format in EGSTRESN. | Exp |
| EGSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of EGSTRESC. EGSTRESN should store all numeric test results or findings. | Exp | |
| EGSTRESU | Unit of the Standardized Result | Char | (UNIT) | Variable Qualifier | Standardized unit used for EGSTRESC and EGSTRESN. | Exp |
| EGSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in EGORRES. | Perm |
| EGREASND | Reason Not Done | Char | Record Qualifier | Describes why EGSTAT is NOT DONE, such as BROKEN EQUIPMENT. | Perm | |
| EGXFN | ECG External File Name | Char | Record Qualifier | File name and path for the external ECG Waveform file. Would be used if applicant is requested to submit waveform. | Perm | |
| EGNAM | Laboratory Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm | |
| EGMETHOD | Method of ECG Test | Char | (EGMETHOD) | Record Qualifier | Method of the test or examination. Examples: 12 LEAD STANDARD, 6 LEAD STANDARD. | Exp |
| EGLEAD | Lead Used for Measurement | Char | (EGLEAD) | Record Qualifier | Lead identified to capture the measurement. | Exp |
| EGCSTATE | Consciousness State | Char | (CSTATE) | Record Qualifier | Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS. | Exp |
| EGBLFL | Baseline Flag | Char | (NY) | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is applicant defined. | Exp |
| EGDRVFL | Derived Flag | Char | (NY) | 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 are not as originally received or collected, are examples of records that might be derived for the submission datasets. | Perm |
| EGEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Should be null for records that contain collected or derived data. Examples: RESPONSIBLE SCIENTIST, PRINCIPAL INVESTIGATOR, PEER REVIEWER. | Perm | |
| EGEXCLFL | Exclusion Flag | Char | (NY) | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm |
| EGREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when EGEXCLFL is Y. | Perm | |
| EGUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the timing of the performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm |
| VISITDY | Planned Study Day of Collection | Num | Timing | Planned study day of collection. Should be an integer. | Perm | |
| EGDTC | Date/Time of ECG Collection | Char | ISO 8601 duration or interval | Timing | Date/Time of ECG data collection, in ISO 8601 format. For indicating measurement over a continuous period, DTC should be used to indicate start date/time of collection. | Exp |
| EGENDTC | End Date/Time of ECG Collection | Char | ISO 8601 duration or interval | Timing | Date/Time of end of the ECG data collection, in ISO 8601 format. Should be populated for measurement over a continuous period only. | Perm |
| EGDY | Study Day of ECG Collection | Num | Timing | Study day of the ECG measurement collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
| EGENDY | Study Day of End of ECG Collection | Num | Timing | Study day of the end of the ECG measurement collection, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
| EGNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | |
| EGNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of EGNOMDY as presented in the study report. Examples: Pre-Treatment, Week 4, Day 28. | Perm | |
| EGTPT | Planned Time Point Name | Char | Timing | Text description of time when ECG data should be collected. Note: 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: Predose, 1 Hour Postdose. | 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 format) relative to a fixed time point reference (EGTPTREF). This variable is useful where there are repetitive measures. 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, if used for EGTPTNUM, and EGTPT. It is recommended that EGTPTREF be as descriptive as possible so the reference time point can be inferred without looking at others variables. Example: DAY 1 FIRST DOSE. | Perm | |
| EGRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 duration or interval | Timing | Date/Time of the reference time point, EGTPTREF. | Perm |
| EGEVLINT | Evaluation Interval | Char | ISO 8601 duration or interval | Timing | Length of evaluation interval in ISO 8601 duration format. Used in place of EGSTINT and EGENINT when EGTPTREF is not available. | Perm |
| EGSTINT | Planned Start of Assessment Interval | Char | ISO 8601 duration | Timing | Planned Start of an asessment interval relative to Time Point Reference (EGTPTREF) in ISO 8601 duration format. | Perm |
| EGENINT | Planned End of Assessment Interval | Char | ISO 8601 duration | Timing | Planned End of an assessment interval relative to Time Point Reference (EGTPTREF) in ISO 8601 duration format. | Perm |
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