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8.0 Site Queries and Data Notifications
Philips BioTel Research uses a Query Management System (QMS) to communicate issues with submitted data to
selected site personnel. Sites will be emailed login credentials and a link to access the QMS once they have been
final qualified.
A data query or data notification email can be sent for the following reasons:
Data Query: If the data cannot be loaded or analyzed a query will be sent and held open until it is resolved.
Data Notification: If there is a minor discrepancy with the data, an email notification will be sent though the
data will proceed through the process.
Queries will be sent to your site via email within 5 business days of receipt at Philips BioTel Research. We will
follow-up with your site once a week until the queries are resolved. If your site is unresponsive or the issue has
not been resolved after three follow-up attempts, approximately 21 days, the issue will then be escalated to the
Sponsor study team for further direction.
9.0 CardioPortal
Philips BioTel Research ECG reports are posted on CardioPortal after receipt of the ECGs. Reporting can be
delayed due to poor quality of the ECG recording or a pending site query.
At the beginning of the study, the site will receive a Site Information Form that allows them to identify one
person from their site to obtain access to CardioPortal. The identified person will be provided a username,
password, CardioPortal login instructions and a Quick Reference Guide via email. If you have any questions
regarding login credentials, please contact BTRsupport@gobio.com.
TPS-SM-72/ v: 1.1/ ed:30Nov2018
ECG Acquisition Guide
Page 14 of 17
TM-79602-01 / v: 1.0 / ed: 27Apr2022
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