ECG Terminology - Package 33

• Discussion on whether to develop Holter ECG domain (Diane and Fred)
• Before creating CT for QTTEST-CD, the ECG team would like to better understand the new ECG QT Correction Model Data domain (Diane's request)
• ECG team's comments and questions over the updated EG example: https://wiki.cdisc.org/display/SDTMIG33/PR+Example+2 (Diane's request)

Holter Domain Discussion -

Issues:

1. Cardiologist evaluation: normal vs abnormal
2. Data output for holter is much larger than ECG 
3. Data that can't fit into the current EG domain: findings and tests currently not in the controlled lists (the result and test codelists are extensible, if not controlled by CDISC, can be added to sponsor specific codelist), further characterization of the device.

Decisions:

1. Will not create Holter ECG domain - final decision?
2. Add "holter monitoring/recording" to the ECG Test Method codelist and map specific Holter ECG Tests and results to the method of holter monitoring - basically it would be a restricted tests/results only for Holter Monitoring.
3. There will be two codelists supporting the EGTESTCD variable: ECG Test Code and Holter ECG Test Code. Need to update the EG domain in SDTMIG v3.3 to reflect this change, also add a Holter example in the IG3.3, update assumptions and show users that both regular ECG and holter ECG datasets can be represented by the EG domain. This change may or may not make IGv3.3 release.

• Kalai to send holter data example for team review
• Diane to dicuss with the SDS team to update the EG domain in IG3.3 to show Holter datasets.

• Show Kalai's examples and discuss her questions about the new ECG domain assumptions
  • Need volunteers to help Diane with Holter ECG example
• Before creating CT for QTTEST-CD, the ECG team would like to better understand the new ECG QT Correction Model Data domain (Diane's request)
  • What QTTEST/CD terms are Diane requesting from the example (looks like Diane only requested for two) 
• ECG team's comments and questions over the updated EG example: PR Example 2 (Diane's request)

Holter Domain Discussion - Continued:

Regulatory guidance on what should be submitted for Holter? CDISC will not create a Holter domain for 3.3.

• QT Correction Model Domain Discussion with CDISC leadership team

1. During the QTTAUG development, the ADaM team was involved and reviewed the content of TAUG. Depending on who is processing the QT correction data, QT data can be represented in either ADaM or SDTM. From the FDA’s perspective, it is best to represent the data consistently in one place. Therefore the final decision was to have QT correction model data in SDTM. This solution is not ideal but it provides a consistent way of representing this type of data.
2. An ad hoc QT terminology team will be formed to deal with terminology request. Request will be removed from the ECG CT team.

• New term request: Holter Monitoring
• Brief team on QT request final decision