Program Description

This three day conference will offer current information, tools, best practices, and training to assure that you’re up-to-date and compliant in your clinical research practice. The program will feature live opening and closing plenary sessions, 8 educational tracks with on demand content and live Q+A, a peer-driven poster program and award competition, plus sponsor and exhibit opportunities.    

Who Should Attend

Clinical research professionals including investigators, research coordinators, research associates, project managers, consultants, educators, and administrators. Such participants may be affiliated with medical centers; cooperative research groups; research consortia; pharmaceutical, device, and biotechnology companies; contract research organizations; site management organizations; and independent research firms.

Learning Objectives

Upon completion of this course the attendee should be able to:

  • Discuss how to better connect with patients while better complying with new regulations that promote participant understanding.
  • Discuss what to consider when planning and managing behavioral health research 4
  • Discuss the requirements for including neonates and children in research
  • Discuss creating a Clinical Evaluation Report (CER) that meets international regulators’ expectations
  • Discuss key areas in monitoring and assessment tools to evaluate monitoring adequacy
  • Describe informed consent unanticipated problems and provide strategies to prevent
  • Discuss how to revise or re-negotiated a budget with confidence
  • Discuss strategies to minimize risk and improve quality in investigator-initiated trials
  • Discuss ideas to streamline the start-up process in a Clinical Trials Office in an academic institution or other similar setting
  • Discuss FDA’s expectations and regulations when selected for an FDA audit
  • Discuss best practices and potential approaches to managing projects involving complex data collection structures
  • Discuss practical methods for conducting foreign trials that rely upon the United States for regulatory purposes
  • Discuss European legislation updates
  • Discuss ways to work with study team members and other stakeholders to implement quality assurance within an academic organization.
  • Discuss factors that promote as well as hinder research compliance and integrity and practices that may help protect against research integrity violations
  • Discuss how to seek professional mentorship and effectively network in the field of clinical trials/translational research
  • Discuss the various aspects regarding eligibility criteria and study procedures of oncology investigator-initiated interventional clinical trial protocols
  • Discuss how to organize and complete the study start up quickly and accurately to ensure compliance
  • Discuss unique community engaged research recruitment and tools to set up a research initiative at a large scale event
  • Discuss high level planning of the enrollment and how the resources can be well-managed
  • Discuss tools to oversee vendors and mitigate risk
  • Discuss opportunities and challenges with internal collaboration
  • Discuss the value of in-home visits and understand the basics
  • Discuss common questions related to the revised Rule and implement the requirements for informed consent in the revised Common Rule
  • Discuss identifying and resolving key risk issues in clinical trial agreements in a proper and efficient manner
  • Discuss the requirements and strategies required to develop the Clinical Research Response Toolkit (CCRT) and how to customize it to fit the rapid response needs for conducting clinical research during an infectious disease outbreak
  • Discuss viable and economic alternatives for educating a highly efficient workforce