Think Like a Clinical Trial Site Auditor - Webinar CD/Transcript

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Think Like a Clinical Trial Site Auditor: Strategies for Successful Monitoring

Clinical trial site monitors are expected to ensure a study site is following study protocol and GCPs — and, when necessary, identify and fix deficiencies.

Studies show, however, that monitors that are good at identifying deficiencies frequently fail when it comes to fixing them.

What does this mean for you and your site? That you may have serious deficiencies (or worse, a pattern of serious deficiencies) that could require lengthy and expensive CAPAs … extensive remediation … and even lost trial data.

How can you avoid getting into such situations?

By ordering the Think Like a Clinical Trial Site Auditor: Strategies for Successful Monitoring webinar CD and transcript.

In this session, you'll learn to start thinking from the perspective of an auditor, rather than waiting fearfully for what an auditor might have to say about your site.

In doing so, you'll quickly find your monitoring practices transformed, becoming far more effective than in the past, going beyond spotting problems to actually fixing them.

In just 90 minutes, you'll learn such specifics as:

  • Key differences between auditing and monitoring  and how to look at your site more like an auditor does
  • Strategies used by seasoned auditors to help them move beyond simply listing deficiencies and focus on the correct issues
  • Going beyond the template. A site monitoring template is a great roadmap for finding and fixing problems at a site — if you know how to use it
  • Practical methods to eliminate finger-pointing and, instead, launch effective corrective and preventive actions in response to monitoring findings

Plus, you'll gain understanding of how to prepare your monitoring reports with an auditor's thought process in mind … the problem patterns auditors watch for in reports … how auditors suss out deficiencies over time, by investigator, even by checking office records … and much more.

Finally, you'll learn how monitors, study coordinators and investigators can all work together to successfully find the root of a problem, rather than just document deficiencies.

  • Regulatory affairs directors
  • Compliance officers
  • Legal counsel

Ms. Pamela Nelson, RN, currently resides in Allen, TX. Pam has been a nurse for over 30 years. She worked for many years in Oncology before entering into Clinical Research.

Pam founded the Bracane Company, a medical services consulting firm in 2002. The Bracane Company provides functional services to the research industry including trial management, supplies and QA compliance. The Bracane Company is a Certified Minority Woman Owned Business Enterprise.