The Digital Measurement and Annotation Module adds study-specific measurement protocols with cardiologist instructions. Optional VERITAS™ semi-automatic caliper placement speeds analysis and adds accuracy and consistency. Blinding and randomization features support E14 QT study requirements.
Administrators assign role-based permissions and study access to E-Scribe™ and Microsoft® Active Directory user accounts. Authorized Windows™ users can view ECGs without having to enter additional credentials. All ECG activity is tracked with record-specific audit trails. Passwords and reasons can be enabled for 21 CFR Part 11 compliance.
Customized demographic fields such as subject and visit numbers can be defined for each study.
ECG data can be exported in the XML format required by the FDA as well as Mortara's data exchange XML format. Study results can be consolidated in a single XML file as needed. ECGs can also be exported in PDF and TIFF formats.
Customizable automatic processing rules route ECGs to any destination, for any reason. ECGs can be printed, e-mailed, faxed, exported, and added to worklists based on ECG status, demographics, automatic measurements, interpretation, and acquisition priority flag.
Configurable worklists organize ECGs according to a study's workflow processes. Worklists give quick access to ECGs requiring demographics verification, measurements, and quality checks.