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Brody School of Medicine
Clinical Trials Office






Clinical Trials Working Group

 
Purpose
The purpose of the Clinical Trials Working Group is to establish a standardized, uniform process for initiating new clinical trials at East Carolina University.
 
Mandates of Clinical Trials Working Group
  • Improve and speed up process whereby clinical trials are initiated and performed at East Carolina University and create corresponding standard operating procedures for their administration.
  • Formal tracking of clinical trials.
  • Help to insure that all studies will be conducted in accordance with the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), the Health Insurance Portability and Accountability Act (HIPAA), State of North Carolina law and East Carolina University policies and procedures.
  • Review post-approval to insure compliance with contractual, budgetary, regulatory, legal and other requirements.
  • Provide education to and be a resource for university personnel involved in clinical trials.
 
Clinical Trials Working Group Membership
  • Office of the Associate Dean for Research and Graduate Studies, School of Medicine
  • Clinical Trials Officer
  • Representative(s) from Office of Sponsored Programs (OSP)
  • Representative(s) from Administration and Finance
  • Representative(s) from Grants and Contracts Administration
  • Representative(s) from the Office of the University Attorney
  • Clinical Trials Office Staff
  • Representative(s) from Risk Management
  • Representative(s) from Compliance Office
 
Responsibilities
The Clinical Trials Working Group will meet as needed. Administrative duties such as scheduling meetings, preparing agendas, collecting forms/paperwork and keeping minutes will be performed by designated members of the Working Group. Each group member will be responsible for reviewing each Clinical Trial in their area of expertise and for tracking timelines relative to these areas.