Agenda

Quality Management Virtual Conference 


Day 1


1:00 to 2:00 pm ET - The Importance of Quality Management System (QMS) in the Conduct of Clinical Trials

Sandhya Patel, BScN, BSc, Independent Consultant  

This session will discuss the importance of QMS in clinical research. It will focus on the components of QMS, the implementation of Quality Assurance Programs, and the importance of institutional support.

2:00 to 3:00 pm ET - Risk Management and Quality Systems

Alyssa Gateman, MPH, CCRP, Director of Quality Assurance, Yale University, Center for Clinical Investigation

This session will explore the roots and evolution of Risk Management, identify FDA regulations and ICH Good Clinical Practice expectations surrounding Risk Management, and review the key steps and elements in Risk Management and Quality Systems.

3:00 to 3:15 pm ET – Break

3:15 to 4:15 pm ET - Training and Tools Used to Assess and Control Risk within Clinical Trial Project Management

Janelle Allen, MS, CCRP, Professional Consultant & Corporate Trainer, Faculty at Miami University

This session will detail best practices in assessing and mitigating risk in clinical trial project management. Review of professional tools and training pathways will be investigated to optimally equip teams.

Day 2


1: 00 to 2:00 pm ET - Instituting an Internal Monitoring Program for Academic Institutions

Greg Staios, MSc, CCRP, Professor, Seneca College, School of Biological Sciences and Applied Chemistry, Clinical Research Program

Monitoring can be an effective method to complement an internal quality program by providing with ongoing and early information when quality issues may be becoming concerning within a particular study.  While the benefits of such a program are clear, many institutions struggle with lack of resources and support to institute such programs.  The aim this talk will be to provide attendees with key information regarding risk assessments, monitoring plan creation, monitor training and providing ongoing support and oversight of monitors in the field as well as providing them with a potential plan of action that could be instituted in their own institutions.

2:00 to 3:00 pm ET - Building a Quality Assurance Program to Manage the Risk Associated with Investigator-Initiated Studies

Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality and Safety, Dartmouth-Hitchcock Medical Center

The objective of this talk is to discuss how to develop and implement a Quality Assurance (QA) Program for Investigator-Initiated Trials (IITs). The presentation will focus on:  1) discussing the essential components of a successful IIT QA program and 2) providing the audience with strategies for program development and sustainability.

3:00 to 3:15 pm ET – Break

3:15 to 4:15 pm ET - QA Initiatives: Hands-On Quality and Study Tools Working Group

Jennifer Li, BSc, CCRP, Quality Assurance Supervisor, Princess Margaret Cancer Centre

The speaker will share two quality initiatives at an academic research centre, from planning to implementation. The Hands-On Quality program invites staff within the Research Program to conduct a “real-life” quality assurance review. The Study Tools Working Group consists of representatives from various research departments and meets monthly to review and provide feedback on study tools.

 Day 3


1:00 to 2:00 pm ET - Audit/Inspection Readiness: Part 1: Setting Up for Success

Alyssa Gateman, MPH, CCRP, Director of Quality Assurance, Yale University, Center for Clinical Investigation

Jessica Rowe, MA, MS, Human Research Protections Program Manager, WellSpan Health

This session will cover the essentials of conducting an audit/inspection ready study, from startup to close out, including best practices for prospectively maintaining essential documents necessary for a successful audit/inspection. Part 1 of this session will also provide guidance on management from the time of audit/inspection notification through the visit itself.

2:00 to 3:00 pm ET - Audit/Inspection Readiness: Part 2: Successfully Crossing the Finish Line

Alyssa Gateman, MPH, CCRP, Director of Quality Assurance, Yale University, Center for Clinical Investigation

Jessica Rowe, MA, MS, Human Research Protections Program Manager, WellSpan Health

This session will provide best strategies on audit/inspection close out processes, FDA classifications and reporting requirements. Part 2 will include formulating appropriate audit/inspection responses through use of root cause analysis techniques and CAPA development.

3:00 to 3:15 pm ET – Break

 3:15 to 4:15 pm ET - Management of Serious Breaches and Non-Compliance

Jennifer Gaskin, CCRP, Senior Director, CQA, Centrexion Therapeutics Corp.

This session will discuss the management of serious breaches and non-compliance while protecting the integrity of the investigation and the rights of the investigator and sponsor. It will help teams to address the sometimes conflicting responsibilities and outcomes of serious breaches and noncompliance.

Day 4


1:00 to 2:00 pm ET – Impact of Systemic Non-Compliance

Nancy Wintering, MSW, LSW, CCRP, Assistant Director of Research, Thomas Jefferson University  

This session will outline the impact of system non-compliance, sanctions, and fraud.

2:00 to 2:15 – Break

2:15 to 3:15 pm ET - Using QA and QC trends to Drive Education and Training

Janelle Allen, MS, CCRP, Professional Consultant & Corporate Trainer, Faculty at Miami University

This session will outline top QA and QC trends to elucidate ideal training and educational needs. It will help teams hone in on focus areas of interest to create efficiency and optimal performance.

3:15 to 4:15 pm ET – Faculty Question and Answer Session