• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » EMA Publishes Nine Q&As Discussing New DMC Guidelines

EMA Publishes Nine Q&As Discussing New DMC Guidelines

October 12, 2020

A new guideline from the European Medicines Agency (EMA) provides recommendations on how data monitoring committees (DMC) should proceed when considering stopping a trial.

The recommendations in the question-and-answer supplement to the EMA’s existing DMC guidelines are not binding for the trial sponsor but the agency suggests that sponsors should notify the ethics committee and regulatory bodies if they don’t plan to follow DMC recommendations to stop or significantly modify their trial.

According to the EMA, both the DMC and the sponsor’s representative(s) should make efforts “to reconcile their opposing views” about stopping a trial. If this reconciliation isn’t possible, a closed session with the DMC, senior sponsor staff and external experts should be convened to reach a consensus.

Read the full EMA document here: https://bit.ly/2GNoj3k.

COVID-19
  • Related Directories

    Olumiant (baricitinib)

    Veklury (remdesivir)

    Comirnaty (COVID-19 Vaccine, mRNA)

Upcoming Events

  • 06Jun

    Gene & Cell Therapy Regulation: Comparability and Other New Developments

  • 07Jun

    Developing World-Class SOPs: Optimizing Quality and Compliance

  • 08Jun

    Implementing ICH E8 R1 Recommendations Increases Site and Participant Relationship Scoring Measures

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • MAGI East 2023

    MAGI East 2023 Preview: Janssen Reports on Environmental Impact of Trials

  • Complexity-360x240.png

    Phase 3 Trials Significantly Rising in Complexity, Says CSDD

  • Quality Level Scale

    Build Quality into Trials Like You’d Build a House, Says FDA’s BIMO Director

  • DE&I

    Trust-Building, Community Connection Still Essential to DE&I Efforts, Experts Say

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 or Share My Data

Footer Logo

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

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing