Article | March 8, 2021

EMA Expands Use Of Remote Source Data Verification

By Bree Burks, RN, MSN, Veeva Systems, Inc.

Blocks saying Guidance

The European Medicines Agency (EMA) has expanded the use and scope of remote source data verification (rSDV) in clinical trials. The updated guidance, now in its fourth version, justifies the use of rSDV on more trials with fewer restrictions.

This is a positive step forward for the industry as the new guidance balances patient safety with the needs of study sponsors, sites, and investigators in maintaining compliance and minimizing risk to trial integrity while dealing with disruptions caused by COVID-19.

Read how the updated guidance justifies the use of rSDV on more trials with fewer restrictions.

VIEW THE ARTICLE!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.

Subscribe to Clinical Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Clinical Leader