ACRP Certification Exam Live Study Session

Prepare for your upcoming ACRP Certification exam with a two-hour, live study session hosted by an ACRP Certified instruction. The study session will cover the Detailed Content Outlines for the exams as well as content from the ICH Guidelines and the Declaration of Helsinki. A question and answer session with the instructor will be included.

Risk-Based Monitoring: The Essentials

Become an expert on quality and risk-management strategies and procedures. This interactive eLearning course answers the fundamental questions: What is RBM and how is it different from the standard monitoring approach?

Write Like an 8th Grader! Improving Readability in Clinical Research

How do you ensure that your clinical research materials are readable for the audiences you want to reach? This session will help you learn how to measure and improve the readability of your clinical research communications to a participant and public-facing audience. We will discuss the importance of readability and explore the pros and cons of tools you can use. Case examples from the Duke Clinical Research Institute including informed consent forms, recruitment materials, and lay summaries will highlight how to use free and existing resources to improve your communication.

Updates on Fraud, Waste, and Abuse in Clinical Research and the False Claims Act

Whistleblower Acts play an important role in detecting fraud, waste and abuse. A person who “knows” of fraud being committed against the government can file a lawsuit and, in some cases, receive a reward for bringing original information about a violation to the government’s attention. Because of the importance of the False Claims Acts in clinical research, this presentation will provide a primer on the Acts, address fraud enforcement trends and the various “hot button” issues in clinical research. It will also discuss how non-compliance compromises not only the financial and operational viability of current trials, but may result in a loss of funding, a risk of fines and penalties imposed by oversight agencies, settlement costs and/or damages arising from actions, and diminution of the organization’s reputation.

Unveiling the Mystery of Quality Tolerance Limits

This session focuses on answering the questions of what quality tolerance limits (QTLs), risk indicators, and thresholds are by defining them and discussing how to establish them. We will look at examples of QTLs, risk indicators, and thresholds and discuss appropriate responses to breaches in the thresholds. In addition, documentation of breaches will be reviewed, reporting expectations and long-term plans for the QTLs, risk indicators, and thresholds. Key take-aways will include examples of QTLs, risk indicators, and thresholds to help one get started with establishing QTLs at their organization.