The October 2021 Clinical Research Staff Quarterly Training will focus on sponsor-initiated studies.
Join us on October 21 for the next session of the Tufts Medical Center (Tufts MC) and Tufts CTSI Professional Education Clinical Research Staff Quarterly Training series.
This quarter will be all about sponsor-initiated studies: from study start-up to audits, we will cover tools, resources, tips, and best practices to help you run a successful study. These quarterly trainings are also a great way to get connected to the community of clinical research professionals at Tufts MC.
Alyssa Cabrera, MPH, Senior Project Manager, Tufts CTSI
Carly Tucker, MPH, Clinical Research Compliance Manager, Tufts Medical Center
Kimberly Garabedian, IRB Analyst, Tufts Medical Center
Vidya Iyer, MBBS, CPI, Manager, Tufts CTSI Clinical and Translational Research Center (CTRC)
The Study Start-up Toolkit
This section will cover how the Study Start-up Toolkit can be used as a resource for getting clinical trials up and running. We will walk you through key sections of the toolkit and how it can support overall trial efficiency. You will walk away with a clear understanding of study start-up and your role in supporting sponsor-initiated studies during this phase.
Did you know there are a number of resources available to help you maintain audit readiness? The Tufts Health Sciences IRB will discuss best practices for conducting routine self-audits to keep your regulatory files in order and introduce self-auditing tools to ensure your study is always in an audit-ready state! In addition, the Tufts MC Compliance Department will also discuss their audit preparation resources.
Surviving the Sponsor Audit
In this section, we will cover a broad overview of the regulatory bodies that can audit an investigator/site. You will learn some of the major reasons for being audited and the difference between sponsor audit versus a monitoring visit. You get an in-depth review of best practices and tips that will prepare you for sponsor audits.
Who should attend
Clinical research staff are encouraged to attend.
Thursday, October 21, 2021
Online via Zoom (a link will be sent to those who register).