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Management Forum

Clinical Trial Monitoring Training Course

This course will assure monitors understand the importance of compliance with latest ICH GCP R3 requirements, and how these apply to monitoring clinical trials in the future.

★★★★★ "Fantastic, energetic, and positive. Very clear describing of the topics and good structure. Discussi... more"

21-22 July 2025 »
from £1299

Need help? Enrol/reserve

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

Course overview

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. Regulatory authorities promote these alternative ways of monitoring trial data and the future is likely to include a more hybrid monitoring approach.

This highly interactive course, which includes group discussions, ensures that monitors not only understand the importance of compliance with the latest GCP standards but also gain insights into how new monitoring approaches are shaping the future of clinical trials.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

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/reserve

This course will cover:

Day 1
Day 2

ICH GCP R3 Compliance considerations for monitoring clinical trials for the future

What is the role of the monitor/CRA to comply with GCP and changes as a result of the pandemic and technological advances?
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, 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

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Laura Brown
Independent Pharmaceutical Consultant

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

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

21-22 July 2025

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 14825

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 16 Jun

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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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; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Clinical Trial Monitoring training course

Fantastic, energetic, and positive. Very clear describing of the topics and good structure. Discussions. It made me feel more involved in the webinar.

Jul 29 2024

Viktoriia Kyrylenko Ukraine
Project Manager, BIOPHARMA PLASMA LLC