Resources

Author: Shannon Roznoski

Shannon Roznoski

As Director of Product Management, Shannon guides the strategic planning and management of OnCore and Forte EDC. In her role, she acts as a strong advocate for 21 CFR Part 11 awareness and the adoption of industry standards to ensure Forte solutions meet the needs of its customer community. Shannon has 14 years of clinical data management and IT experience, and is a CCDM through SCDM.

Website: Forte

Report Card: Methods for Managing Lab Norms within your EDC System

How varying protocols and operations should change your organization’s approach to handling external data in your EDC system.

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Better Together: Site and Sponsor Collaboration to Revolutionize eSource in Clinical Trials 

Forte’s mission to better connect Sites and Sponsors is embodied in the Trial Data Exchange (formerly known as DIRECT). Our goal is to standardize and automate the data exchange between stakeholders rather than relying on per protocol solutions, manual data entry and manual report compilation. While the Trial Data Exchange will be able to exchange

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5 Steps to Follow When Shopping for a Validated EDC System

Shopping for a validated EDC system can seem like a daunting task. Learn five steps that make the process less confusing.

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How to Use CDASH Controlled Terminology

Shannon Roznoski of Forte discusses controlled terminology and the uses of these standardized lists of terminology.

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21 CFR Part 11: Vendor Vs Sponsor Responsibilities – Q&A

Shannon Roznoski, answers questions following her recent webinar on the roles both vendor and sponsor play during the validation process of an EDC system.

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Tips for Writing Effective Edit Checks in eCRFs

Shannon Roznoski of Forte shares tips for writing effective edit checks in electronic case report forms (eCRFs).

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Creating Electronic Case Report Form Templates Using CDASH

Shannon Roznoski of Forte shares her experiences in creating electronic case report form (eCRF) templates using the CDASH standard.

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