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.
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.
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.
Are you prepared for the risk management requirements in ICH GCP E6 (R2)? This session will provide a high-level walk through of quality risk management, the key components of a risk management program, and how to conduct a risk assessment at the system and protocol level. We will review the key steps of the process: risk identification, assessment, control, review, reporting, management, and communication. Having an effective risk management program not only ensures compliance with the ICH GCP E6 R2 requirements, but also ensures continuous improvement strategies for your clinical trials. Practical take-aways will be shared along with sample tools.
Purpose: focuses on practical aspects of the preparation and execution of clinical study initiation; identifying and describing key activities, processes, and critical personnel.
Methods: provides a practical overview of the significant processes in starting research at a site and a clear understanding of the main components of study initiation: document management, logistics, and people management. Guidance, tools, and resources help the primary investigator and coordinator perform efficiently and understand how their responsibilities tie together with the tasks and duties of others.
Conclusions: Organization and adequate time for the initiation process are critical to successful studies. Multiple activities must be orchestrated and performed concurrently, requiring use of study tools and efficient processes. Identification and use of numerous research resources improve efficiency of study initiation and decrease work load and frustration.