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Management Forum

Clinical Trial Monitoring Training Course

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

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.

★★★★★ "It was good to actively take part as this makes you think harder about what you have been told."

29-30 April 2024
+ 11-12 July 2024, 2-3 December 2024 »
from £1099

Need help? Enrol or reserve

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

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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. 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:

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 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

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

29-30 April 2024

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 13523

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

Until 25 Mar

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

11-12 July 2024

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 13740

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

Until 06 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

View basket

Not ready to book yet?

for 7 days, no obligation

2-3 December 2024

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 13968

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

Until 28 Oct

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

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.