Ponemah's SEND Output Description
The table below shows the various Variable Names, their definition, and where the Ponemah software reads the information to populate in the table.
| Variable Name | Variable Label | CDISC Notes | location Ponemah Reports it from |
| STUDYID | Study Identifier | Unique identifier for a study. | PPP3 Setup>SEND |
| DOMAIN | Domain Abbreviation | Two-character abbreviation for the domain. | Automatically done by Ponemah |
| USUBJID | Unique Subject Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | PPP3 Setup>Groups |
| --SEQ | Sequence Number | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Automatically done by Ponemah |
| --TESTCD | Test Short Name | 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. | PPP3 Setup>Channel Input Setup>Derived Parameters; managed by the SEND.XML file |
| --TEST | Test Name | Long name for EGTESTCD. The value in EGTEST cannot be longer than 40 characters. Examples: ECG Mean Heart Rate, Summary (Max) QT Duration. | PPP3 Setup>Channel Input Setup>Derived Parameters; managed by the SEND.XML file |
| --CAT | Position of Subject | Used to define a category of the ECG test performed. Examples: MEASUREMENT, DIAGNOSIS, INTERPRETATION. | Ponemah data will be labeled as "Measurement" |
| --POS | Position | 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. | ECG Position defined in the field in PPP3 Setup>SEND |
| --ORRES | Result or Findings as Collected | Result of the ECG measurement or finding as originally received or collected. | Value of derived parameter |
| --ORRESU | Unit of the Original Result | 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. | Units of derived parameter |
| --STRESC | Standardized Result in Character Format | 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. | Value of derived parameter |
| --STRESN | Standardized Result in Numeric Format | Used for numeric results or findings in standard format; contains the numeric form of EGSTRESC. EGSTRESN should store all numeric test results or findings. | Value of derived parameter |
| --STRESU | Unit of the Standardized Result | Standardized unit used for EGSTRESC and EGSTRESN. | Unit of derived parameter |
| --STAT | Completion Status | Used to indicate when a test is not done or result is missing. Should be null if a result exists in EGORRES. | Automatically done by Ponemah; Either NULL OR "NOT DONE" |
| --REASND | Reason Not Done | Describes why EGSTAT is NOT DONE, such as BROKEN EQUIPMENT. | Automatically done by Ponemah; Either NULL OR "INCOMPLETE WAVEFORM" |
| --NAM | Laboratory Name | Name or identifier of the laboratory or vendor that provided the test results. | Laboratory Name entered in the field in PPP3 Setup>SEND |
| --METHOD | Method of Test | Method of the test or examination. Examples: 12 LEAD STANDARD, 6 LEAD STANDARD. | Method defined in PPP3 Setup>SEND; managed by the SEND.XML file |
| --LEAD | Lead Used for Measurement | Lead identified to capture the measurement. | Label Name entered in PPP3 Setup>Channel Input Setup for each channel |
| --CSTATE | Consciousness State | Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS. | Defined in PPP3 Setup>SEND; managed by the SEND.XML file |
| --BLFL | Baseline Flag | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor defined. | Automatically done by Ponemah; Either NULL OR "Y" ('Y' when Data Reduction has a Control value) |
| --EVAL | Evaluator | 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. | Not currently being populated by Ponemah |
| --DTC | Date/Time of ECG Collection | 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. | Timestamp at the start of the Data Reduction interval |
| --ENDTC | End Date/Time of ECG Collection | Date/Time of end of the ECG data collection, in ISO 8601 format. Should be populated for measurement over a continuous period only. | Timestamp at the end of the Data Reduction interval |
| --DY | Study Day of ECG Collection | Study day of the ECG measurement collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Will report NULL unless an Exposure domain data containing actual dose times is imported |
| --ENDY | Study Day of End of ECG Collection | Study day of the end of the ECG measurement collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Will report NULL unless an Exposure domain data containing actual dose times is imported |
| --NOMDY | Nominal Study Day for Tabulations | 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. | Defined in PPP3 Setup>SEND |
| --TPT | Planned Time Point Name | 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. | Automically done by Ponemah when dose marker is chosen in PPP3>Data Reduction Setup (eg 1hr 45m Predose) |
| --TPTNUM | Planned Time Point Number | Numerical version of EGTPT to aid in sorting. | Automatically done by Ponemah |
| --ELTM | Planned Elapsed Time from Time Point Ref | 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: | Data Reduction labels entered in the field in PPP3 Setup>Data Reduction Setup |
| --TPTREF | Time Point Reference | “-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. | Automatically done by Ponemah with data entered in NOMDY and Dose label in Data Reduction; does not allow for negative study day, it will take the absolute value |
| --RFTDTC | Date/Time of Reference Time Point | Date/Time of the reference time point, EGTPTREF. | Will report NULL unless an Exposure domain containing actual dose times is imported |
| --STINT | Planned Start of Assessment Interval | Planned Start of an asessment interval relative to Time Point Reference (EGTPTREF) in ISO 8601 duration format. | ISO 8601 time format at the start of the Data Reduction interval (eg PT15M, for 15 minutes post dose start time) |
| --ENINT | Planned End of Assessment Interval | Planned End of an assessment interval relative to Time Point Reference (EGTPTREF) in ISO 8601 duration format. | ISO 8601 time format at the end of the Data Reduction interval (eg PT30M, for 30 minutes post dose end time) |
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