Keeping Your Research Study Compliant: What You Should Know

This clinical compliance training will explain how human subject research studies are regulated. Attendees will learn best practices to ensure compliance with clinical research regulations.

Why Should you Attend:

Research compliance is a growing, changing, and challenging arena. This can be especially difficult for individuals or small organizations conducting human subjects research studies because there is so much to know and a readymade network of individuals and resources may not be on hand. The following questions will often crop up for those embarking on clinical research:

• What are the regulations?
• Who are the regulatory bodies?
• What should I know if I am asked to help out with a research study?
• How do I know if this is regular practice or research?
• How can I protect myself?

This clinical research compliance webinar will address these questions and help attendees learn the best practices to ensure they don’t fall short in complying with regulatory requirements.

Areas Covered in the Webinar:

• Research regulatory framework
• Knowing your role
• How sound practices lead to fewer compliance issues
• Case examples – is it research?
• What could happen if a study goes wrong
• Resources

Who Will Benefit:

This webinar will provide valuable assistance to following personnel:

• Clinical research coordinator
• Investigators
• Administration in charge of clinical research
• Human subjects research professionals
• Regulatory compliance
• Those involved in health plans and health care clearinghouses

Instructor Profile:

Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University.