How Principal Investigators Can Maintain Oversight: Tips for Sites
It is now a requirement under ICH GCP E6 (R2) addendum for the Principal Investigator (PI) to demonstrate their oversight of a clinical trial. Sites need to be able to provide evidence that the PI is actively involved in the conduct of the trial and is assuming the required responsibilities. The delegation log is not a paper exercise – the PI needs to be able to support their actions if questioned. There has been considerable thought around the format that will be required in the case of an inspection. This session will provide opportunities for PI oversight tips and regulatory oversight ideas from providers themselves.
Facilitator
Nathan Levens, Vice President of Site Solutions, RealTime Software Solutions
Panelists
Rick Arlow, CEO and Founder, Complion
Wilfredo E. De Jesus-Monge, MD, MSc, Chief of Clinical Research, Hospital HIMA, San Pablo Caguas
Kay Scroggins, RN, Board Member, Flourish Research
Help, This Study is Complicated! Current & Future Needs of Sites
Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through the years have not been documented, evaluated or published to guide new staff as programs grow and take on new challenging protocols. It is easy to say what your needs are in the moment when planning or conducting a study, but what about predicting future needs when it comes to complex trials? Top sites and CROs share current best practices that they are doing to manage complex protocols in this session.
Facilitator
April M. Coburn, Associate Director, Therapeutic Area, Site Activation Liaison, ICON, PLC
Panelists
Betsy Henk, Director, SCRI, Quality Assurance, Sarah Cannon Research Institute
Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare
Jennifer Hunter, CCRP, BAAS, Director of Research Operations, Mary Crowley Cancer Research
Sofie Vanderplaten, MSc, Executive Director, Project Delivery, PPD, part of Thermo Fisher Scientific
Site-Centricity & Relationships: The Importance of Site Needs
Over the past decade, we have put a strong focus on patients. However, we are seeing now that we need to give additional recognition to research sites and ensure site needs are met. In this session, we will discuss the definition of ‘site-centricity’ and how site relationships play a role in achieving a more site-centric model.
Facilitator
Dan Otap, Principal, Alliance and Partnerships Lead, Genentech
Panelists
Karri Venn, RD, CCRC, COO, President, Centricity Research
Dawn Overcash, Director, Strategic Site Collaborations, PPD, part of Thermo Fisher Scientific
Steven Ringel, General Manager, Time, Tempus Labs
Jeffrey Sorenson, MBA, CEO, Yunu.io