Program Description
Join us for an enriching experience at the 2025 Annual Conference, offering cutting-edge information, tools, best practices, and training to keep you up-to-date and compliant in your clinical research practice. Delve into opening and closing plenary sessions, 8 educational tracks, a peer-driven poster program and award competition, and exciting sponsor and exhibit opportunities. Don't miss this opportunity to enhance your expertise and thrive in the field of clinical research.
Who Should Attend
This conference will welcome a diverse range of clinical research professionals, including investigators, research coordinators, research associates, project managers, consultants, educators, administrators, and individuals 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 Preview
Upon the completion of this course, the attendee should be able to:
- Discuss current and planned FDA initiatives.
- Discuss Phase I trial design trends.
- Discuss the relevance of regulations and guidance to the administration of clinical trials.
- Discuss the use of the CTCAE and best practices for documentation.
- Learn the importance of teaching patients about changing the lifestyle habits.
- Describe current cellular therapies available, common adverse events that occur and answers to
- commonly asked questions.
- Discuss basic ethical concerns about performing sham surgery in clinical research trials for PD.
- Discuss the importance of the inclusion of rural sites in clinical trials.
- Discuss the responsibilities associated with the administration of clinical trials.
- Discuss the proposed key changes in ICH E6 (R3) and how they affect clinical trial operations.
- Discuss a plan for supporting academic clinical trials with minimal funding.
- Discuss issues related to managing clinical trials at a rural site.
- Discuss implementation of a quality assurance program.
- Discuss the nuances of working with Spanish-speaking research part
- Discuss the use of site technology.
- Discuss how to survive and thrive during an inspection or audit.
- Discuss available tools that should help monitors to become more organized and more productive.
- Discuss strategies for communicating effectively with IRBs/Study teams
- Discuss AI use in research.
- Discuss the use of concepts of respect for persons, beneficence, nonmaleficence, and justice to review research.
- Discuss returning genetic testing results from research studies to improve study set-up.
- Discuss the changing ethics of informed consent related to biospecimens in clinical research.
- Discuss the value proposition presented by decentralized clinical trials.
- Discuss vitro diagnostic clinical trials conducted in the US.
- Discuss the basics of how machine learning is integrated into medical devices.
And so much more! Each Annual Conference session and their corresponding objective is available to review in the SOCRA mobile app.