Investigational Device Accountability
Overview:
Investigational device accountability is outlined in the FDA's regulations. Included in this topic is the receipt, storage, distribution, reconciliation, return and authorized destruction of investigational devices. Many industry sponsors already have standard operating procedures outline these policies but there are instances when a standard operating procedure or guideline does not already exist and those working with these devices need to know their responsibilities.
Learning objectives:
- Define investigational devices
- Review the regulations and guidance
- Discuss device accountability requirements
- Examine sample materials
Why should you attend: Investigational device accountability ensures that the investigational (non-FDA approved) devices are used only as described in IRB approved protocols under the direction and management of appropriately qualified research team members.
Areas Covered in the Session:
- Investigator Responsibility
- Applicable regulations and guidance
- Definition of Accountability
- Investigational device ordering and receipt
- Investigational device storage
- Investigational device requisition and use
- Investigational device disposition
Who Will Benefit:
- Investigators
- Researchers
- Research Staff
- Study Coordinators
- Auditors
- Research Administrators
Speaker 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. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.
Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
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. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.
Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.