Management Forum Logo

Presented by
Management Forum

Clinical Trial Monitoring Training Course

Including remote, centralized, and Hybrid monitoring and a focus on inspection readiness

This course will assure monitors understand the importance of compliance with GCP standards, and how these apply to monitoring clinical trials including during the pandemic and in the future.

5-6 June 2023
+ 9-10 October 2023
from £1099

Need help?  Enrol or reserve

  • Format: Live online
  • CPD: 12 hours for your records
  • Certificate of completion


With regulatory inspectors increasingly finding GCP issues with monitoring clinical trials, it is becoming even more important for the biopharmaceutical industry, study sites, and CROs to employ efficient and accurate strategies for monitoring clinical trials.

Also, the global COVID-19 pandemic has changed the ways clinical trials are monitored and resulted in remote and centralized monitoring techniques at the forefront of monitoring. This has created an environment that requires monitors to not only purely focus on-site visits. These alternative ways of monitoring trial data are promoted by regulatory authorities and the future is likely to include a more hybrid monitoring approach.

This course will assure monitors understand the importance of compliance with latest GCP standards, and how new monitoring approaches in clinical trials are being employed for the future.

Key Objectives:

Ensure GCP compliance for monitoring clinical trials including during Covid and monitoring approaches for the future
Evaluate the development of monitoring plans through protocol analysis for remote risk management
Discuss tools and risk evaluation approaches for remote monitoring
Ensure appropriate site selection, initiation, monitoring, and close out visits are carried out including during a pandemic.
Review sponsor and CRO oversight of monitors

Who should attend

  • Monitors
  • Clinical research associates (CRA)
  • Clinical Trial Managers
  • Study Coordinators
  • Project managers 
  • Research nurses 
  • Study site assistants 
  • Those responsible for oversight of monitoring
  • Investigators seeking to move into clinical trial monitoring 

This course will benefit those involved in the monitoring of clinical trials, including new and soon-to-be monitors. This will also be an ideal refresher including how monitoring has changed because of the pandemic and those responsible for oversight of monitors.

Enrol or reserve

The Clinical Trial Monitoring course will cover:

GCP Compliance considerations for monitoring clinical including during a pandemic and the future

  • What is the role of the monitor/CRA to comply with GCP and changes as a result of the Covid and technology innovation?
  • The monitoring role in the context of having a quality system for clinical trials
  • ICH E6R3 and update and impact on monitoring

Site Selection

  • Criteria for selecting suitable sites
  • Site Feasibility Assessment 

Site Initiation

  • Preparing for site initiation
  • Agenda and content of site initiation visit report to comply with GCP
  • Risks of inappropriate site initiation & resulting issues 

Monitoring Visit Procedures

  • Preparing for site monitoring
  • Important consideration during SDV and virtual clinical trials
  • Identifying issues and developing solutions
  • Monitoring visit report to comply with GCP

Study close-out visits

  • Preparing for site closure
  • Final preparing of documentation and entering data
  • Content of closeout visit and follow-up to comply with GCP

Planning Patient recruitment strategies

  • Optimising recruitment to clinical trials
  • Common recruitment problems in clinical trials and how these may be managed 

Oversight of monitoring

  • Co-monitoring visits including by the sponsor and CRO management 
  • Preparing a sponsor monitoring oversight visit
  • Follow-up with the monitor/CRO

GCP and Documentation and Archiving

  • Requirements of the GCP Inspectors 
  • TMF considerations

Reporting Serious Breaches and preventing Fraud: What monitors need to know

  • What are the signs a monitor should look for Serious Breaches and Fraud?
  • What actions should the monitor take?
  • How to report serious breaches

Preparing for Audit and Inspection visits to comply with GCP

  • How to prepare effectively for a study site audit and/or regulatory inspection 
  • What do QA departments and inspectors look for? 
  • A brief review of regulatory authority inspections findings

Enrol or reserve

Laura Brown
LB Training and Development Ltd

Dr. Laura Brown is an independent pharmaceutical QA and training consultant. Laura is an expert in GCP compliance for running and monitoring clinical trials. She has more than 20 years of experience in the pharmaceutical industry in several senior roles and has worked for several companies, including GSK, Hoechst Marion Roussel, and Phoenix International in quality assurance of clinical trials.

Laura is an international expert on regulatory requirements in clinical research and was Chair of the Institute of Clinical Research GCP Forum for over six years. She writes regularly on clinical research regulatory requirements and is the author of several articles on the EU Clinical Trial Regulation, ‘The Planning of International Drug Development’ in the Clinical Research Manual, and has written a chapter in International Pharmaceutical Product Registration.

























































































































More details

Book Clinical Trial Monitoring Live online training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

5-6 June 2023

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12762

  • GBP 1,299
  • EUR 1,869
  • USD 2,129

View basket 

Not ready to book yet?

for 7 days, no obligation

9-10 October 2023

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12763

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 04 Sep

View basket 

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.


  • MED-EL
  • Med-El Elektromed. Geräte GmbH

United Kingdom

  • Frontier Science Scotland

Czech Republic

  • Product Life Ltd.


  • Dr. Falk Pharma GMBH


  • JSC Olainfarm


  • Atos Medical

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749