• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » EMA Expands Use of Remote Source Data Verification in Clinical Trials

EMA Expands Use of Remote Source Data Verification in Clinical Trials

February 15, 2021

The European Medicines Agency (EMA) will now permit remote source data verification (rSDV) in trials dealing with serious or life-threatening conditions as long as measures are in place to protect patients’ private data.

The remote option is allowed in cases in which critical data must be verified to avoid unacceptable risks to participants’ safety or the reliability or integrity of trial results, the guidance says. The EMA also expanded rSDV in cases “involving particularly vulnerable participants, such as children or those temporarily or permanently incapable of giving their informed consent.”

Before using rSDV, the EMA said, trials should have a plan for protecting patients’ privacy that could include such features as a policy on how a site can share deidentified participant documents with CRAs, security controls that limit remote access to patients’ electronic medical records or a system for video review of medical records that does not require sending data directly to CRAs and does not allow them to record images during the review.

Read the EMA’s guidance here: https://bit.ly/3q09sEp.

Upcoming Events

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

Featured Products

  • Regenerative Medicine – Steps to Accelerate Development : PDF

    Regenerative Medicine: Steps to Accelerate Development

  • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

    Clinical Trial Agreements: A Guide to Key Words and Phrases

Featured Stories

  • InputinLights-360x240.png

    Seeking Patient Input Early Helps Ensure Minority Participation in Trials

  • Oncology-360x240.png

    Global Oncology Trial Launches Drop Dramatically During Pandemic, Study Shows

  • Qualification-360x240.png

    Sites and Sponsors Streamlining Qualification Efforts with Technology, Process Revisions

  • New Algorithm Tested and Validated by CSDD Highly Predictive of Patient Burden

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing