UPCOMING WEBINAR: Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?
We are pleased to invite you to attend an upcoming webinar hosted by the DIA Study Endpoints Community and presented by the ePRO Consortium.
Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?
Date: Wednesday, September 18, 2019
Time: 11:00 am – 12:00 pm Eastern (US)
Join via Zoom Meeting: diaglobal.zoom.us/j/401173715
Good Clinical Practice (GCP)/ethics review guidelines (ICH E6 R2) indicate that written information provided to the patient must be submitted for ethical review. However, many clinical studies also include clinical outcome assessments (COAs) to measure how patients feel and function in order to evaluate clinical benefit of treatment interventions. These instruments are often completed electronically (eCOA) and are presented to patients for completion as a scientific aspect of the research, not as inducements to participate.
Many have broadly interpreted the GCP requirement concerning “written information” to mean that screenshots for every proposed patient-facing image must be provided for review, approval, and filing prior to study initiation. The presenters question whether requests from ethics review bodies for eCOA screenshots is warranted and will propose a new path forward.
Sue Vallow, RPh, MBA, MA; Executive Director, Patient-Centered Outcomes Research Worldwide Clinical Trials
Steve Raymond, PhD; Chief Scientist, Scientific Affairs, ERT
Art Gertel; CEO, MedSciCom, LLC
Olivier Chassany, MD, PhD, HDR; Deputy Director of Patient-Centered Outcomes Research, Paris-Diderot University and INSERM
David Forster, JD, MA, CIP; Chief Compliance Officer, WIRB-Copernicus Group
|Please share or like on LinkedIn|