Recent regulatory guidance and the introduction of the PRO and ePRO Consortia are helping to change the landscape with respect to patient self-report data and this educational seminar will feature both the sponsor and partner perspectives on best practice for the future. Hear from industry experts about how to choose the best methodology as part of your future Patient Reported Outcomes strategy.

AGENDA

Keynote Address:

"Validating a gold standard instrument for ePRO - how the eC-SSRS (electronic Columbia Suicidality Severity Rating Scale) has been successfully translated into an electronic modality and is now supporting the FDA guidelines in assessing suicidal ideation and behavior"

Kelly Posner, Ph.D.., Principal Investigator, Columbia/FDA Classification Project for Drug Safety Analysis; Principal Investigator, Center for Suicide

Risk Assessment, Columbia University

John Greist, MD, Director, Healthcare Technology Systems, Inc., Clinical Professor of Psychiatry, University of Wisconsin School of Medicine and Public Health

Michael Federico, VP ePRO Solutions, ERT

A review of the latest ePRO Regulatory Guidance and an introduction to the C-Path Institute's ePRO and PRO Consortia - How the latest guidance impacts on the entire suite of ePRO methodologies and the pros and cons of employing each within your trial.
ERT ePRO Scientific Officer

PRO Scale Selection - How to best plan for success in your studies with respect to selection of the optimal diaries, scales and assessments for collecting your patient self-report data. Hear from an sponsor about their experience of the do's and don'ts and review a case study demonstrating the approach they have taken.
Sponsor speaker

ePRO Modality Selection - One size does not fit all when it comes to ePRO.
How impartial consulting and a technology-agnostic approach to ePRO ensures that sponsors match the right solution with specific patient population demographics and geographic locations.
ERT Product Manager

Data integration - A review of the technical and operational process required to ensure that your ePRO data is seamlessly integrated within your eCRF.
Partner Speaker

There will also be a bonus eC-CSSRS Workshop in Northbrook, IL on September 13th entitled The Need for Prospective Suicidality Monitoring

Prospective Assessment Using the Columbia-Suicide Severity Rating Scale
(C-SSRS): Improved Precision with Reduced Burden Kelly Posner, Ph.D., Principal Investigator, Columbia/FDA Classification Project for Drug Safety Analysis; Principal Investigator, Center for Suicide Risk Assessment, Columbia University

Self-Reported Suicidality Monitoring by eC-SSRS John Greist, MD, Director, Healthcare Technology Systems, Inc., Clinical Professor of Psychiatry, University of Wisconsin School of Medicine and Public Health

eC-SSRS Operational Overview
Prospective Assessment in clinical trials, the eC-SSRS and self-rating at the site Michael Federico, VP ePRO Solutions, ERT

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