Clinical Investigation at External Study Sites Under a University-based IND/IDE Application
The conduct of a multi-center clinical trial (i.e., a study involving one or more external sites) under a University-based Investigational New Drug (IND) or Investigational Device Exemption (IDE) application is only permitted upon satisfaction of the requirements set forth by the University. Faculty seeking to conduct a multi-site clinical trial under a University-based IND or IDE are encouraged to consult with the Division of Education and Compliance for Human Subject Research as early as possible to receive education on the extent of sponsor responsibilities.
To decrease risk to the University-based Sponsor, external study sites should be encouraged, whenever possible, to each submit their own IND or IDE application incorporating the common clinical trial protocol. This approach ensures compliance liabilities are assumed independently by each of the external study sites rather than globally by the University of Pittsburgh.
To find out more, review the Guidance for Investigators document and Formal Application to conduct a multi-center clinical trial. Please email IND and IDE Support at IIS@pitt.edu with any questions regarding the application or guidance.