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Description
ECG Test Results (EG) is a findings domain that contains ECG data, including position of the subject, method of evaluation, all cycle measurements and all findings from the ECG including an overall interpretation if collected.
This section provides EG domain metadata for 3 different data collection scenarios.
Scenario 1: Central Reading
In this scenario, results are captured directly by an electronic device and transmitted separately or read by a central vendor, rather than recorded on the CRF. The accession number and date collected on the CRF can be used as an aid in reconciliation of the electronic data.
Scenario 2: Local Reading
In this scenario, subjects' ECGs are performed and analyzed, and then the results are recorded directly on the CRF. 
Scenario 3: Central Reading with Investigator Assessment of Clinical Significance Assessment and/or Overall Interpretation
In this scenario, results are captured directly by an electronic device by a central vendor. The results are provided in an electronic file to the applicant. In addition, the results are provided to the investigator for assessment of clinical significance for any abnormal values, and that information is provided to the applicant on the CRF.
Specification
TIG v1.0 Metadata Check for CDASH Domain Specification Table Beta 2
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
| Observation Class | Domain | Data Collection Scenario | Implementation Options | Order Number | Collection Variable | Collection Variable Label | DRAFT Collection Definition | Question Text | Prompt | Data Type | Collection Core | Case Report Form Completion Instructions | Tabulation Target | Mapping Instructions | Controlled Terminology Codelist Name | Subset Controlled Terminology/CDASH Codelist Name | Implementation Notes |
| Findings | EG | Central Reading | N/A | 1 | STUDYID | Study Identifier | A unique identifier for a study. | What is the study identifier? | [Protocol/Study] | Char | HR | N/A | STUDYID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation. |
| Findings | EG | Central Reading | N/A | 2 | SITEID | Study Site Identifier | A unique identifier for a site within a study. | What is the site identifier? | Site (Identifier) | Char | HR | N/A | DM.SITEID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. EDC: This should be pre-populated. |
| Findings | EG | Central Reading | N/A | 3 | SUBJID | Subject Identifier for the Study | A unique subject identifier within a site and a study. | What [is/was] the (study) [subject/participant] identifier? | [Subject/Participant] (Identifier) | Char | HR | Record the identifier for the subject. | DM.SUBJID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This variable collection is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain. |
| Findings | EG | Central Reading | N/A | 4 | VISIT | Visit Name | The name of an encounter that encompasses planned and unplanned study interventions, procedures, and assessments that may be performed on a subject. | What is the visit name? | [Visit] | Char | R/C | N/A | VISIT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | The name of the clinical encounter is typically pre-printed or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain. |
| Findings | EG | Central Reading | N/A | 5 | VISDAT | Visit Date | Date the encounter occurred (or started). | What [is/was] the date of the visit? | (Visit) Date | Char | R/C | Record the [date/start date] of the visit using this format (DD-MON-YYYY). | N/A | This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable EGDTC in ISO 8601 format. | N/A | N/A | The date the ECG measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the ECG measurements at that visit, or the collection date can be included on the ECG CRF using the date (EGDAT) field. |
| Findings | EG | Central Reading | N/A | 6 | EGCAT | Category for ECG | A grouping of topic-variable values based on user-defined characteristics. | What was the category of the ECG finding? | [ECG Category]; NULL | Char | O | Record the ECG finding category, if not pre-printed on the CRF. | EGCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included as the column header. |
| Findings | EG | Central Reading | N/A | 7 | EGSCAT | Subcategory for ECG | A sub-division of the EGCAT values based on user-defined characteristics. | What was the subcategory of the ECG finding? | [ECG Subcategory]; NULL | Char | O | Record the ECG finding subcategory, if not pre-printed on the CRF. | EGSCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as "Subcategory" can be included as the column header EGSCAT can only be used if there is an EGCAT, and it must be a subcategorization of EGCAT. |
| Findings | EG | Central Reading | N/A | 8 | EGPERF | ECG Performed | An indication of whether a planned ECG measurement, series of ECG measurements, tests, or observations was performed. | Was the ECG performed? | ECG Performed | Char | HR | Indicate whether or not an ECG or specific ECG test was done. | EGSTAT | This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable EGSTAT. If the collection field EGPERF= "N", the value of EGSTAT will be "NOT DONE". If EGPERF = "Y", EGSTAT should be null. A combination of tabulation variables (e.g., EGCAT and EGSCAT, EGTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable EGTESTCD would be populated as EGALL and an appropriate test name (EGTEST) provided. | (NY) | N/A | This may be implemented for an entire ECG, or a specific ECG test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing. |
| Findings | EG | Central Reading | N/A | 9 | EGREPNUM | ECG Repetition Number | 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 timepoint, within a visit; multiple measurements of blood pressure, multiple analyses of a sample). | Which repetition of the ECG is this? | Repetition number | Char | O | Record which repetition of the ECG this is. | EGREPNUM | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | If there are multiple ECGs, this is used to record in which order this ECG occurred. |
| Findings | EG | Central Reading | N/A | 10 | EGREFID | ECG Reference ID | An internal or external identifier of the ECG (e.g., waveform number). | What was the (ECG) [reference identifier/accession number]? | (ECG) [Reference Identifier/Accession Number] | Char | O | Record the identifier number assigned. | EGREFID | Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain. | N/A | N/A | This can be used to confirm that the appropriate data record is present in the electronic transfer if this reference ID happens to be available to the site at the time of collection. It can also be used to link the clinical significance assessment to the proper record in the electronic data. (e.g., UUID for external waveform file, session number automatically generated by electronic equipment). |
| Findings | EG | Central Reading | N/A | 11 | EGMETHOD | Method of ECG Test | Method of the test or examination. | What was the method used for the ECG? | Method | Char | O | Record the method used for the ECG. | EGMETHOD | Maps directly to the tabulation variable listed in the Tabulation Target column. | (EGMETHOD) | N/A | Results may be affected by whether conditions for ECG as specified in the protocol were properly met. One possible condition is the method used to collect or calculate the ECG data. If the protocol requires this type of information, then this question may be included to confirm that the method used matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:
|
| Findings | EG | Central Reading | N/A | 12 | EGLEAD | ECG Lead Location Used for Measurement | The lead used for the measurement (e.g., "LEAD I", "LEAD II", "LEAD III", "LEAD rV2", "LEAD V1") | Which lead location was used for this measurement? | Lead Location | Char | O | Record which lead was used for this measurement. | EGLEAD | Maps directly to the tabulation variable listed in the Tabulation Target column. | (EGLEAD) | N/A | This is used when more specificity for the location is desired for the ECG data. |
| Findings | EG | Central Reading | N/A | 13 | EGPOS | ECG Position of Subject | The position of the subject during the ECG measurement. | What was the position of the subject during the ECG measurement? | Position | Char | O | Record the position of the subject during the ECG. | EGPOS | Maps directly to the tabulation variable listed in the Tabulation Target column. | (POSITION) | N/A | Results may be affected by whether conditions for ECG as specified in the protocol were properly met. One common condition is the subject's position. If the protocol requires this type of information, then this question may be included to confirm that the subject's position matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:
|
| Findings | EG | Central Reading | N/A | 14 | EGDAT | ECG Date | The date the ECG was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What was the date of the ECG? | ECG Date | Char | R/C | Record the date the ECG was done using this format (DD-MON-YYYY). | EGDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable EGDTC in ISO 8601 format. | N/A | N/A | A complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required. |
| Findings | EG | Central Reading | N/A | 15 | EGTPT | ECG Planned Time Point Name | A text description of planned time point when measurements should be taken as defined in the protocol. | What was the planned time point of the ECG measurement? | [Planned Time Point Name] | Char | R/C | Record the time point labels for when the ECG test should be taken, if not pre-printed on the CRF. | EGTPT | Maps directly to the tabulation variable listed in the Tabulation Target column. Tabulation time-point anchors EGTPTREF (text description) and EGRFTDTC (date/time) may be needed, as well as tabulation variables EGTPTNUM, EGELTM. | N/A | N/A | Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Planned Time Point" can be included as the column header. |
| Findings | EG | Central Reading | N/A | 16 | EGTIM | ECG Time | Time of ECG, represented in an unambiguous time format (e.g., hh:mm:ss). | What was the time the ECG was collected? | ECG Time | Char | R/C | Record the time the ECG was done (as complete as possible). | EGDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable EGDTC in ISO 8601 format. | N/A | N/A | May be required when multiple assessments are done on 1 day or when the timing in relationship to study product is required for analysis. |
| Findings | EG | Local Reading | N/A | 1 | STUDYID | Study Identifier | A unique identifier for a study. | What is the study identifier? | [Protocol/Study] | Char | HR | N/A | STUDYID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation. |
| Findings | EG | Local Reading | N/A | 2 | SITEID | Study Site Identifier | A unique identifier for a site within a study. | What is the site identifier? | Site (Identifier) | Char | HR | N/A | DM.SITEID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. EDC: This should be pre-populated. |
| Findings | EG | Local Reading | N/A | 3 | SUBJID | Subject Identifier for the Study | A unique subject identifier within a site and a study. | What [is/was] the (study) [subject/participant] identifier? | [Subject/Participant] (Identifier) | Char | HR | Record the identifier for the subject. | DM.SUBJID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain. |
| Findings | EG | Local Reading | N/A | 4 | VISIT | Visit Name | The name of an encounter that encompasses planned and unplanned study interventions, procedures, and assessments that may be performed on a subject. | What is the visit name? | [Visit] | Char | R/C | N/A | VISIT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain. |
| Findings | EG | Local Reading | N/A | 5 | VISDAT | Visit Date | Date the encounter occurred (or started). | What [is/was] the date of the visit? | (Visit) Date | Char | R/C | Record the [date/start date] of the visit using this format (DD-MON-YYYY). | N/A | This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable EGDTC in ISO 8601 format. | N/A | N/A | The date the ECG measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the ECG measurements at that visit, or the collection date can be included on the ECG CRF using the date (EGDAT) field. |
| Findings | EG | Local Reading | N/A | 6 | EGCAT | Category for ECG | A grouping of topic-variable values based on user-defined characteristics. | What was the category of the ECG finding? | [ECG Category]; NULL | Char | O | Record the ECG finding category, if not pre-printed on the CRF. | EGCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included as the column header. |
| Findings | EG | Local Reading | N/A | 7 | EGSCAT | Subcategory for ECG | A sub-division of the EGCAT values based on user-defined characteristics. | What was the subcategory of the ECG finding? | [ECG Subcategory]; NULL | Char | O | Record the ECG finding subcategory, if not pre-printed on the CRF. | EGSCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as "Subcategory" can be included as the column header EGSCAT can only be used if there is an EGCAT, and it must be a subcategorization of EGCAT. |
| Findings | EG | Local Reading | N/A | 8 | EGPERF | ECG Performed | An indication of whether a planned measurement, series of measurements, test, or observation was performed. | Was the ECG performed? | ECG Performed | Char | HR | Indicate whether or not ECG or specific ECG test was done. | EGSTAT | This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable EGSTAT. If the collection field EGPERF="N", the value of EGSTAT will be "NOT DONE". If EGPERF="Y", EGSTAT should be null. A combination of tabulation variables ( e.g., EGCAT and EGSCAT, EGTPT ) is used to indicate that multiple tests were not done. In this situation, the tabulation variable EGTESTCD would be populated as EGALL and an appropriate test name (EGTEST) provided. nal information. | (NY) | N/A | This may be implemented for an entire ECG, or a specific ECG test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing. |
| Findings | EG | Local Reading | N/A | 9 | EGREPNUM | ECG Repetition Number | 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 timepoint, within a visit; multiple measurements of blood pressure, multiple analyses of a sample). | What repetition of the ECG is this? | Repetition Number | Char | O | Record which repetition of the ECG this is. | EGREPNUM | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | If there are multiple ECGs, this is used to record in which order this ECG occurred. |
| Findings | EG | Local Reading | N/A | 10 | EGMETHOD | Method of ECG Test | Method of the test or examination. | What was the method used for the ECG? | Method | Char | O | Record the method used for the ECG. | EGMETHOD | Maps directly to the tabulation variable listed in the Tabulation Target column. | (EGMETHOD) | N/A | Results may be affected by whether conditions for ECG as specified in the protocol were properly met. One possible condition is the method used to collect or calculate the ECG data. If the protocol requires this type of information, then this question may be included to confirm that the method used matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:
|
| Findings | EG | Local Reading | N/A | 11 | EGLEAD | ECG Lead Location Used for Measurement | The lead used for the measurement (e.g., "LEAD I", "LEAD II", "LEAD III", "LEAD rV2", "LEAD V1"). | Which lead location was used for this measurement? | Lead Location | Char | O | Record which lead was used for this measurement. | EGLEAD | Maps directly to the tabulation variable listed in the Tabulation Target column. | (EGLEAD) | N/A | This is used when more specificity for the location is desired for the ECG data. |
| Findings | EG | Local Reading | N/A | 12 | EGPOS | ECG Position of Subject | The position of the subject during the ECG measurement. | What was the position of the subject during the ECG measurement? | Position | Char | O | Record the position of the subject during the ECG. | EGPOS | Maps directly to the tabulation variable listed in the Tabulation Target column. | (POSITION) | N/A | Results may be affected by whether conditions for ECG as specified in the protocol were properly met. If the protocol requires this type of information, then this question may be included to confirm that the subject's position matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:
|
| Findings | EG | Local Reading | N/A | 13 | EGDAT | Date of ECG | The date the ECG was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What was the date of the ECG? | ECG Date | Char | R/C | Record the date ECG was done using this format (DD-MON-YYYY). | EGDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable EGDTC in ISO 8601 format. | N/A | N/A | A complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and if so, a separate assessment date field is not required. |
| Findings | EG | Local Reading | N/A | 14 | EGTPT | ECG Planned Time Point Name | A text description of planned time point when measurements should be taken as defined in the protocol. | What was the planned time point of the ECG measurement? | [Planned Time Point Name] | Char | R/C | Record the time point labels for when the ECG test should be taken, if not pre-printed on the CRF. | EGTPT | Maps directly to the tabulation variable listed in the Tabulation Target column. Tabulation time-point anchors EGTPTREF (text description) and EGRFTDTC (date/time) may be needed, as well as tabulation variables EGTPTNUM, EGELTM. | N/A | N/A | Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Planned Time Point" can be included as the column heading. |
| Findings | EG | Local Reading | N/A | 15 | EGTIM | Time of ECG | Time of ECG, represented in an unambiguous time format (e.g., hh:mm:ss). | What was the time the ECG was collected? | ECG Time | Char | R/C | Record the time the ECG was done (as complete as possible). | EGDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable EGDTC in ISO 8601 format. | N/A | N/A | May be required when multiple assessments are done on 1 day or when the timing in relationship to study product is required for analysis. |
| Findings | EG | Local Reading | N/A | 16 | EGTEST | ECG Test or Examination Name | Descriptive name of the measurement or finding. | What was the ECG test name? | [ECG Test Name] | Char | HR | Record the name of the ECG measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended. | EGTEST; EGTESTCD | Maps directly to the tabulation variable listed in the column with the heading Tabulation Target. The tabulation variable EGTESTCD may be determined from the value collected in EGTEST. The tabulation variables EGTESTCD and EGTEST are required in the tabulation datasets. Use appropriate CDISC Controlled Terminology for the test and test code. | (EGTEST) | N/A | Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Test" can be included as the column heading. |
| Findings | EG | Local Reading | N/A | 17 | EGORRES | ECG Result or Finding in Original Units | Result of the measurement or finding as originally received or collected. | What was the result of the ECG? | (Result) | Char | HR | Record test results, interpretations or findings. | EGORRES | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Both quantitative results and interpretive findings or summaries may be recorded here. |
| Findings | EG | Local Reading | N/A | 18 | EGORRESU | ECG Original Units | The unit of the result as originally received or collected. | What was the unit of the ECG results? | Unit | Char | R/C | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | EGORRESU | Maps directly to the tabulation variable listed in the Tabulation Target column. | (UNIT) | (EGORRESU) | May be included if quantitative results are recorded. Because units for quantitative ECG results are typically limited, units should be pre-printed on the CRF with the associated test when possible, rather than having sites record the units. This item is not necessary for qualitative results. |
| Findings | EG | Local Reading | N/A | 19 | EGCLSIG | ECG Clinical Significance | An indication of whether the ECG results were clinically significant. | Was the ECG clinically significant? | Clinically Significant | Char | O | Record whether ECG results were clinically significant. | SUPPEG.QVAL | This does not map directly to a tabulation variable. This information could be represented in a SUPPEG dataset as the value of SUPPEG.QVAL where SUPPEG.QNAM ="EGCLSIG" and SUPPEG.QLABEL="Clinically Significant". | (NY) | N/A | Could apply to specific measurements or to overall interpretation. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 1 | STUDYID | Study Identifier | A unique identifier for a study. | What is the study identifier? | [Protocol/Study] | Char | HR | N/A | STUDYID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 2 | SITEID | Study Site Identifier | A unique identifier for a site within a study | What is the site identifier? | Site (Identifier) | Char | HR | N/A | DM.SITEID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be on the CRFs that are shipped to each site. EDC: This should be pre-populated. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 3 | SUBJID | Subject Identifier for the Study | A unique subject identifier within a site and a study | What [is/was] the (study) [subject/participant] identifier? | [Subject/Participant] (Identifier) | Char | HR | Record the identifier for the subject. | DM.SUBJID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 4 | VISIT | Visit Name | The name of an encounter that encompasses planned and unplanned study interventions, procedures, and assessments that may be performed on a subject. | What is the visit name? | [Visit] | Char | R/C | N/A | VISIT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | The name of the clinical encounter is typically on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 5 | VISDAT | Visit Date | Date the encounter occurred (or started) | What [is/was] the date of the visit? | (Visit) Date | Char | R/C | Record the [date/start date] of the visit using this format (DD-MON-YYYY). | N/A | This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable EGDTC in ISO 8601 format. | N/A | N/A | The date the ECG measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the ECG measurements at that visit, or the collection date can be included on the ECG CRF using the date (EGDAT) field. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 6 | EGCAT | Category for ECG | A grouping of topic-variable values based on user-defined characteristics | What was the category of the ECG finding? | [ECG Category]; NULL | Char | O | Record the ECG finding category, if not on the CRF. | EGCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included as the column heading. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 7 | EGSCAT | Subcategory for ECG | A sub-division of the EGCAT values based on user-defined characteristics | What was the subcategory of the ECG finding? | [ECG Subcategory]; NULL | Char | O | Record the ECG finding subcategory, if not on the CRF. | EGSCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a applicant-defined codelist. If the form is laid out as a grid, then words such as "Subcategory" can be included as the column heading. EGSCAT can only be used if there is an EGCAT, and it must be a subcategorization of EGCAT. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 8 | EGPERF | ECG Performed | An indication of whether a planned measurement, series of measurements, test, or observation was performed | Was the ECG performed? | ECG Performed | Char | HR | Indicate whether or not an ECG or specific ECG test was done. | EGSTAT | This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable EGSTAT. If the collection field EGPERF="N", the value of EGSTAT will be "NOT DONE". If EGPERF="Y", EGSTAT should be null. A combination of tabulation variables (e.g., EGCAT and EGSCAT, EGTPT ) is used to indicate that multiple tests were not done. In this situation, the tabulation variable EGTESTCD would be populated as EGALL and an appropriate test name (EGTEST) provided. | (NY) | N/A | This may be implemented for an entire ECG, or a specific ECG test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 9 | EGREPNUM | ECG Repetition Number | 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 timepoint, within a visit; multiple measurements of blood pressure, multiple analyses of a sample). | Which repetition of the ECG is this? | Repetition Number | Char | O | Record which repetition of the ECG this is. | EGREPNUM | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | If there are multiple ECGs, this is used to record in which order this ECG occurred. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 10 | EGREFID | ECG Reference ID | An internal or external identifier of the ECG (e.g., waveform number) | What was the (ECG) [reference identifier/accession number]? | (ECG) [Reference Identifier/Accession Number] | Char | O | Record the identifier number assigned. | EGREFID | Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain. | N/A | N/A | This can be used to confirm that the appropriate data record is present in the electronic transfer if this reference ID happens to be available to the site at the time of collection. Examples: Universally Unique Identifier (UUID) for external waveform file, session number automatically generated by electronic equipment. This can also be used to link. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 11 | EGMETHOD | Method of ECG Test | Method of the test or examination | What was the method used for the ECG? | Method | Char | O | Record the method used for the ECG. | EGMETHOD | Maps directly to the tabulation variable listed in the Tabulation Target column. | (EGMETHOD) | N/A | Results may be affected by whether conditions for ECG as specified in the protocol were properly met. If the protocol requires this type of information, then this question may be included to confirm that the method used matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:
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| Findings | EG | Central Reading with Investigator Assessment | N/A | 12 | EGLEAD | ECG Lead Location Used for Measurement | The lead used for the measurement (e.g., "LEAD I", "LEAD II", "LEAD III", "LEAD rV2", "LEAD V1") | Which lead location was used for this measurement? | Lead Location | Char | O | Record which lead was used for this measurement. | EGLEAD | Maps directly to the tabulation variable listed in the Tabulation Target column. | (EGLEAD) | N/A | This is used when more specificity for the location is desired for the ECG data. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 13 | EGPOS | ECG Position of Subject | The position of the subject during the ECG measurement | What was the position of the subject during the ECG measurement? | Position | Char | O | Record the position of the subject during the ECG. | EGPOS | Maps directly to the tabulation variable listed in the Tabulation Target column. | (POSITION) | N/A | Results may be affected by whether conditions for ECG as specified in the protocol were properly met. If the protocol requires this type of information, then this question may be included to confirm that the subject's position matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:
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| Findings | EG | Central Reading with Investigator Assessment | N/A | 14 | EGDAT | Date of ECG | The date the ECG was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY) | What was the date of the ECG? | ECG Date | Char | R/C | Record the date ECG was done using this format (DD-MON-YYYY). | EGDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable EGDTC in ISO 8601 format. | N/A | N/A | A complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and if so, a separate assessment date field is not required. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 15 | EGTPT | ECG Planned Time Point Name | A text description of planned time point when measurements should be taken as defined in the protocol | What was the planned time point of the ECG measurement? | [Planned Time Point Name] | Char | R/C | Record the time point labels for when the ECG test should be taken, if not on the CRF. | EGTPT | Maps directly to the tabulation variable listed in the Tabulation Target column. Tabulation time point anchors EGTPTREF (text description) and EGRFTDTC (date/time) may be needed, as well as tabulation variables EGTPTNUM, EGELTM. | N/A | N/A | Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Planned Time Point" can be included as the column heading. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 16 | EGTIM | Time of ECG | Time of ECG, represented in an unambiguous time format (e.g., hh:mm:ss) | What was the time the ECG was collected? | ECG Time | Char | R/C | Record the time the ECG was done (as complete as possible). | EGDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable EGDTC in ISO 8601 format. | N/A | N/A | May be required when multiple assessments are done on 1 day or when the timing in relationship to study product is required for analysis. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 17 | EGEVAL | ECG Evaluator | The role of the person who provided the evaluation | Who provided the information?; Who was the evaluator? | [Evaluator/Reporter] | Char | O | Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR). | EGEVAL | Maps directly to the tabulation variable listed in the Tabulation Target column. | (EVAL) | N/A | Used only for results that are subjective (e.g., assigned by a person or a group). May be pre-printed or collected. Applicants may collect the data using a subset list of controlled terminology on the CRF. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 18 | INTP_EGORRES | ECG Interpretation | Overall interpretation of the result of the measurement or finding | What was the interpretation of the ECG? | Interpretation | Char | O | Record overall interpretations of the ECG. | EGORRES | This does not map directly to a tabulation variable. For the tabulation dataset, the recorded interpretation is populated into the tabulation variable EGORRES where EGTEST= "Interpretation", and EGTESTCD="INTP". | N/A | N/A | The overall interpretation of an ECG is mapped into the appropriate tabaulation test and result variables. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 19 | EGCLSIG | ECG Clinical Significance | An indication of whether the ECG results were clinically significant | Was the ECG clinically significant? | Clinically Significant | Char | HR | Record whether ECG results were clinically significant. | SUPPEG.QVAL | This does not map directly to a tabulation variable. This information could be represented in a SUPPEG dataset as the value of SUPPEG.QVAL where SUPPEG.QNAM = "EGCLSIG" and SUPPEG.QLABEL="Clinically Significant". | (NY) | N/A | Could apply to specific measurements or to overall interpretation. In this scenario, clinical significance could be provided by the investigator. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 20 | EGMHNO | Related Medical History Event ID | Identifier for the medical history event that was reported as a clinically significant ECG finding | What was the identifier for the medical history event that was reported as a clinically significant ECG finding? | Medical History Event Identifier | Char | O | Record the identifier for the medical history event that was reported as a clinically significant ECG finding. | N/A | This does not map directly to a tabulation variable. For the tabulation datasets, may be used to create RELREC to link this record with a record in the MH domain. | N/A | N/A | Intent is to establish a link between the clinically significant ECG finding and the medical history event that was reported. EGMHNO can be used in RELREC to identify a relationship between records in EG dataset and records in the MH dataset. |
| Findings | EG | Central Reading with Investigator Assessment | N/A | 21 | EGAENO | Related Adverse Event ID | Identifier for the adverse event that was reported as a clinically significant ECG finding | What was the identifier for the adverse event(s) that was reported as a clinically significant ECG finding? | Adverse Event Identifier | Char | O | Record the identifier for the adverse event that was the reported as a clinically significant ECG finding. | N/A | This does not map directly to a tabulation variable. For the tabulation datasets, may be used to create RELREC to link this record with a record in the AE domain. | N/A | N/A | Intent is to establish a link between the clinically significant ECG finding and the AE that was reported. EGAENO can be used to identify a relationship between records in EG dataset and records in the AE dataset. |
Assumptions
- The ECG tests that should be collected are not specified by the TIG; this is a medical and scientific decision that should be based on the needs of the protocol and regulatory requirements.
- Applicants should decide which scenario is appropriate for each protocol.
- As required or defined by the study protocol, clinically significant results may need to be reported on the Adverse Event CRF.
- As required or defined by the study protocol, changes that are worsening may need to be reported on the AE CRF.
- As depicted in scenario 3, where the CRF includes site assessment of clinical significance and/or overall interpretation, results are returned to the sites, and the sites complete a CRF page of clinical significance for any abnormal/unexpected values and/or record an overall interpretation of the results. As in scenario 1, the actual testing results are transmitted electronically, but the CRF includes data necessary to identify and rate the clinical significance of the abnormal results.
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