Clinical Trials Monitoring - Comprehensive Training Package (4 Courses)

Clinical trial monitoring is a critical area of concern - get it wrong and the consequences can land a sponsor in regulatory hot water.

To help clinical trial sponsors and research organizations, we have created a comprehensive training webinar recording CD package covering areas such as clinical trial monitoring techniques; audit procedures; differences between auditing and monitoring; and setting up effective Data Monitoring Committees (DMCs).

How It Works:

Each webinar CD package has a series of modules. Our speakers have delivered the modules using PowerPoint slides.

This training is convenient to attend individually or in groups. You don’t have to travel from your office. This means you can afford to have your whole team attend. As the webinar recording CDs are licensed to be used multiple times in a location, you can schedule the training as many times for as many groups/batches as you wish. Your team members will learn the material together; everybody will get the same information.

Webinar Topics included in this package:

• FDA’s Clinical Trials Audit procedures companies should conduct as part of its monitoring program
• Auditing vs. monitoring, defining the purpose, application and process
• Data Monitoring Committees (DMCs) in Clinical Research - its effect on subject public safety and how can it be effectively set up
• Enhanced Monitoring Practices and Techniques That Ensures FDA Compliance

Who will benefit?

These webinar recording CDs will be beneficial to the following:

Personnel in Sponsor Companies (i.e., Pharmaceutical, Biotechnology, Medical Device, etc.); CROs; investigator sites conducting clinical trials; Clinical Research Associates; Study Managers; Site Staff/ Study Coordinators; Quality Assurance auditors; and Regulatory Compliance Associates.

Webinars included in the Package:

FDA’s Clinical Trials Audit procedures companies should conduct as part of its monitoring program (Duration: 60 minutes)

This Clinical Trial Audit training webinar provides information on the importance of having an audit plan in place for clinical trials to be submitted to the FDA. Development of an independent audits/data verification and compliance monitoring program is also discussed.

Areas Covered in the Webinar:

• Key factors of any quality assurance program.
• What audits should constitute an audit program for clinical trial sites.
• Audit plan details.
• Recommendations regarding site selection for audit, audit activities, audit frequency, trending of audit data, identification of quality issues and risks.
• FDA Inspection program for clinical trial sites.
• Most Common FDA findings from clinical site inspections.
• How to use trended data from audits and common FDA findings to ensure audit program will identify these issues.

About the Instructor:

Carol Owen, has been in the Clinical Research Industry for over 20 years. She recently held the position of Director of Quality Assurance for a large Contract Research Organization. She has been involved in training throughout her career particularly in the areas of GCP compliance, FDA regulations and requirements, and audit training.

Auditing vs. monitoring, defining the purpose, application and process (60 minutes)

This Clinical Trial audit training teaches a risk-based approach to the process of monitoring and auditing clinical trial.

Areas Covered in the Webinar:

• Background and Definitions.
• Roles and Responsibilities.
• Symbiosis of Monitoring & Auditing.
• Planning & Conduct of Monitoring & Auditing.
• Identifying & Handling Possible Fraud And Misconduct.
• Ensuring A successful Trial Conduct.
• Continuous Improvement.
• Past Lessons vs. Future Trials.

About the Instructor:

Arash Amirpour, graduated in 1999 with Masters Degree in Natural Sciences from the Technical University of Denmark. He has worked in the pharma industry for more than a decade, and is a certified ISO-9001:2000 Lead Auditor.

Data Monitoring Committees (DMCs) in Clinical Research - its effect on subject public safety and how can it be effectively set up (77 minutes)

This Data Monitoring Committees (DMCs) training for Clinical Research teaches why the increase in using DMCs in Clinical Research affects subject-public safety and hos can they be set up to be effective.

Areas Covered in the Webinar:

• The historical background of why Data and Safety monitoring is essential.
• The purpose of the Data and Safety monitoring plan.
• The Regulatory requirements for safety monitoring.
• Studies requiring a formal Safety Monitoring Committees.
• What does the "Charter" of a DMC compose of?
• What is the composition and function of a DMC?
• What types of studies "require" a DMC?
• Conflict of interest and the DMC.

About the Instructor:

Charles H. Pierce ,MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena. Dr. Pierce serves as an advisor to several clinical research organizations. He has been in the Clinical Research Industry for more than two decades.

Enhanced Monitoring Practices and Techniques That Ensures FDA Compliance (53 minutes)

This Clinical training guides you through Enhanced techniques to optimize productivity without compromising subject safety and quality data in clinical monitoring for US- based premarket trials.

Areas Covered in the Webinar:

• FDA's Clinical Trials Transformation Initiative (CTTI) and concerns surrounding monitoring practices.
• Basic vs. Enhanced monitoring techniques.
• Most Common audit deficiencies noted among sponsors and investigator sites.
• Efficient Monitoring practices before, during and after a site visit.
• Effective Site Monitoring tools and visit reports.
• Effective Site management techniques.
• Monitoring Enhancement Program (i.e., Co-monitoring).

About the Instructor:

Kimberly Kiner, BSc, CCRA is the President of 2K Clinical Consulting, Inc. a niche provider that focuses on simplifying trial management by providing monitoring and co-monitoring services to sponsor companies, CROs and sponsor-investigators. She has more than 13 years of experience in the regulatory/ quality assurance and clinical research industry.

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