Skip to main content

Effectively Managing Changes in Patient-Reported Data

FREE WEBINAR 15.02.2024, 08:00 AM PDT | 11:00 AM EST | 17:00 CET | 20:30 IST
Effectively Managing Changes in Patient-Reported Data
    Session Overview: During this 60-minute webinar, you will hear from Viedoc experts how to adjust existing workflows to align with regulatory expectations surrounding patient-reported data—while ensuring that investigators continue to play a central role in the decision-making process for data modifications.

Overview
Historically, service providers, along with their sponsor clients, restricted modifications to patient-reported data, allowing changes only upon securing sponsor approval. Sponsors were tasked with approving or denying data change requests before implementation. However, regulatory directives now stipulate that it is the investigators and not the sponsors that are responsible for maintaining accurate source records.
During this webinar, you will hear about the process and theory of utilizing service-provider technologies to perform and document changes made to patient-reported data by investigators.

      What You'll Learn
  • How to adopt a process of empowering investigators to make data changes
  • The value of supporting data changes with adequate documentation
  • Ways to allow sponsor oversight without controlling source records
  • How service-provider technologies perform and document changes in a way that is consistent with Good Clinical Practice
Who Should Attend
It is dedicated to anyone working with the design of studies or study design protocols


Please note this is a sponsored industry webinar, and therefore content will be commercially oriented. During the registration process, you will be asked to indicate whether you agree that your fist name, last name, email address and company details provided in the registration form can be shared with the webinar sponsor, Viedoc.


Meet the Speaker
Alan Yeomans
Regulatory Affairs Manager
Viedoc
Alan Yeomans has over 30 years in the industry and has been a speaker at many of the top industry events like eClinical Forum, DIA and CDISC around the world. Alan has been at the company for more than 15 years and he has been an essential contributor to the development of Viedoc.

Sverre Bengtsson
Co-Founder, Owner, and Senior Vice President Strategic Relations,
Viedoc
Sverre Bengtsson has extensive experience in the clinical research industry. For the past 20 years, Sverre has worked tirelessly to promote Viedoc—the most sophisticated EDC and ePRO platform on the market—at conferences and seminars around the world.


Need Support?
Technical support:
Click on the help button on the bottom right, select contact support and email the BlueSky team with any technical issues. Otherwise e-mail directly to support@blueskyelearn.com or call +1-888-705-6002 for immediate help.

General support:
The SCDM Learning team is here to help. Contact us at learning@scdm.org or call +32 232 024 87.