Author: Shannon Roznoski

Shannon Roznoski

As Director of Product Management, Shannon guides the strategic planning and management of Clinical Data Management solutions. She acts as a strong advocate for 21 CFR Part 11 awareness and the adoption of industry standards to ensure Advarra Forte solutions meet the needs of its customer community. Shannon has over 20 years of clinical data management and IT experience, and is a CCDM through SCDM.

Website: Forte

Q&A: How Sites and Sponsors are Collaborating to Move eSource Forward

In this Q&A, Shannon Roznoski from Advarra-Forte and Michael Buckley from Memorial Sloan Kettering Cancer Center answer attendee questions from their webinar, How Sites and Sponsors are Collaborating to Move eSource Forward

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

By inverting the focus from per protocol solutions to holistic site-wide solutions that utilize industry standards, we can revolutionize the use of eSource in clinical trials.

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Reflections on SCDM 2019: Technology’s Role in Transforming Clinical Data Management

Forte’s director of product management attended the SCDM Annual Conference earlier this month, and took the time to reflect on the growth of the clinical data management domain.

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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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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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Designing CRFs for the CDASH Demographics (DM) Domain

Shannon Roznoski of Forte explains how to design electronic case report forms (eCRFs) using the CDASH standard for the Demographics (DM) domain.

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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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