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Management Forum

Clinical Trial Monitoring Training Course

Including inspection readiness and monitoring during a pandemic

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.

2-3 Feb 2023 + 2 more dates

Need help?  Enrol or reserve

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

Overview

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

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. 

It is more important than ever to look at ways to monitor clinical trials including managing the conduct of clinical trials remotely and hybrid approaches. Sites have had to modify strategies to manage patients in clinical trials and sponsors/CROs have had to adapt to meet obligations to the regulatory agencies including EMA and FDA to ensure trials are conducted under GCP.  

Key Objectives:

  • Ensure GCP compliance for monitoring clinical trials including during Covid and monitoring 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.

Who should attend:

  • Monitors
  • Clinical research associates (CRA)
  • Clinical Trial Managers
  • Study Coordinators
  • Project managers 
  • Research nurses 
  • Study site assistants 
  • 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 as a result of the pandemic.

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 

Co-monitoring procedures performed as Sponsor

  • Monitoring plans
  • Co-monitoring visits 
  • Preparing a sponsor monitoring oversight visit
  • Follow-up with the monitor/CRO

GCP and Documentation and Archiving

  • Requirements of the GCP Inspectors 
  • TMF considerations
  • The TMF plan – recommended format for compliance

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

Dr. Laura Brown is an independent pharmaceutical QA and training consultant and the Senior Lecturer for the MSc in RegulatoryAffairs, TOPRA. 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

2-3 Feb 2023

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 12761

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

Until 29 Dec

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Not ready to book yet?

for 7 days, no obligation

5-6 Jun 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 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 01 May

View basket 

 
Not ready to book yet?

for 7 days, no obligation

9-10 Oct 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.

Austria

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

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
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy