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Multicenter Guidance

Clinical Investigation at External Study Sites Under a University-based IND/IDE Application

The conduct of a multicenter clinical trial (i.e., a study involving one or more external sites) under a University-based Investigational New Drug (IND) Application or Investigational Device Exemption (IDE) is only permitted upon satisfaction of the requirements set forth by the University.  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. Faculty seeking to conduct a multi-site clinical trial under a University-based IND or IDE are encouraged to consult with the ECS-HSR as early as possible to receive education on the extent of sponsor responsibilities.

To find out more, review the information below. Please email IND and IDE Support at IIS@pitt.edu with any questions regarding the application or guidance.

A person completing paper application

Multicenter Application

An Application to Conduct a Multicenter Trial must be completed and submitted to IND & IDE Support for review by members of the Office of Research Protections leadership. 
Person on laptop with eyeglasses laying on top of notebook

Multicenter Guidance

Refer to the External Study Site Guidance for the submission and maintenance requirements for the multicenter application.

 
UPitt at spring time

Contract Research Organizations (CRO)

UPitt has established a University-wide Contracted Suppliers Agreement to assist our University-based Sponsors' ability to enter into a contract with a CRO. Working with a CRO may be necessary while conducting multicenter trials to obtain services such as trial monitoring, project management, database development, data management, and regulatory support. 

The Pay, Purchase, and Travel website lists information on each of the contracted suppliers:

Full details on the CROs and contracting process, as well as a matrix for individuals to compare services, can be found on the Purchase, Pay & Travel website.

Should a University-based IND Sponsor enter into an agreement with a CRO, execution of a Transfer of Regulatory Obligations (TORO) should be considered.  Click here for a TORO template.  Please email IND and IDE Support at IIS@pitt.edu with any questions about a TORO.