Clinical Trial Monitoring Training Course

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.

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