Summary

ClinSpark supports a number of workflows that can involve reviews of ECG data. Standard reviews can be done on specific timepoints that allows qualified users to review static outputs of parameters and PDF renderings of ECG waveforms. However, more advanced ECG reviews are also possible allowing investigators and cardiologists the ability to further analyze and annotate ECGs, overlay multiple timepoints to look for trends, or change automatically placed calipers for a more accurate assessment of key ECG parameters for applicable trials.

These advanced reviews mechanisms in ClinSpark are made possible through an integration with the CalECG software, provided from AMPS.

ClinSpark supports advanced reviews through all of the ECG file types supported by CalECG, which includes (but are not limited to) FDA XML, MUSE XML, CardioSoft XML, and Mortara XML.

Overview

The following video provides a high-level overview of the advanced overread capabilities between ClinSpark and CalECG.

Requirements for Use

Advanced overview capabilities are dependent on local user workstations having both CalECG and the ClinSpark Agent installed. The minimum required Agent version for the integration is 1.3.1, however, it’s recommended that users install the latest version of the Agent whenever possible. Details about Agent releases are in other help site articles.

CalECG is expected to be invoked via ClinSpark in the web browser. When done so, it will run in ‘embedded mode’ when opening ECG files, to best accommodate over-read workflows facilitated through the browser.

To support this, a specific build of CalECG version 4.1.0 is used. This build is no different from the commercially available version of CalECG, other than enforcing the requirement for ‘embedded mode’ capabilities and to verify proper licensing. Users will still be able to open CalECG manually outside of ClinSpark to modify certain settings, but they will not be able to manually load in ECG files for review.

The CalECG build which is intended for ClinSpark use is uniquely identifiable. The product name (via the About menu) reports as ‘CalECG-CS’, and the following build number:

To verify that the correct build is installed, users can open the CalECG4.exe executable in the installation directory:

Open

Using the Help menu, select About CalECG4…

Open

Within the About screen, you will see the product name listed as CalECG-CS and Build Info reporting the unique build number, which is different from the commercial release.

Installing CalECG

To acquire the installation files for the ClinSpark specific build of CalECG, customers must reach out to IQVIA via the Service Desk to request a download link.

The installation process can be completed by running the application setup file. Selecting default installation settings is recommended.

Managing License Files

CalECG is a licensed product that requires a valid license file matching the version and build of CalECG being invoked. For example, a version 4.1.0 commercial license file will not work with the ClinSpark specific build of CalECG.

Each installation of CalECG comes pre-configured with a ‘demo’ license which allows limited access to basic functions of the application. However, the ‘demo’ license file will not work with the ClinSpark embedded workflows.

License files for CalECG can only be obtained through AMPS.

Each license file is provided with an activation period. Once the expiry date of the license file has passed, CalECG can longer be invoked.

License files are located in the default installation directory C:\Program Files(x86)\AMPS\CalECG\Licenses

Multiple license files can exist in that directory. Each time invoked, CalECG will check the directory to ensure that a valid (non-expired) file exists, and will use whichever license file is still active.

Enabling Advanced Reviews

During onboarding, customers will work with IQVIA to establish a proper set of environment configurations that enable the use of advanced reviews and configurations of CalECG features. These are some examples of applicable settings:

With certain system configurations in place, users can also enable advanced reviews on a per-study basis by visiting the ECG > Configure component.

Troubleshooting

ClinSpark users will receive an error message if attempting to invoke advanced review capabilities without the proper version of CalECG installed, or, without a valid license file.

CalECG will also provide a ‘warning’ message to users when licenses are soon to expire. These messages are informational and should not prevent use of CalECG or ClinSpark until expiry date as passed.

ClinSpark Agent log files may also contain logged statements if issues occur between ClinSpark and CalECG. It’s recommended that customers reach out via the service desk to report any potential interface issues, and supply the ClinSpark Agent log files during that process to further troubleshoot.

Additional Resources

The User Manual and System Manual documents are provided to users via the CalECG installation process, accessibly within the application installation directory. They are also provided here for reference.