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SCHOOL OF MEDICINE
ROUTING FOR CORPORATE-SPONSORED
CLINICAL STUDY AGREEMENTS THROUGH THE
CENTER FOR CLINICAL TRIALS (CCT)


Where do I obtain the CCT Service Request Form? 

  • The Service Request Form is located at www.umaryland.edu/cct
  • When the Service Request Form has been completed and submitted to CCT, CCT will e-mail a Cover Sheet to the PI


When should I begin routing?
Route proposals after the Cover Sheet has been received from CCT


Where do I obtain the routing form? 
Web-based routing form at https://ord2.umaryland.edu/uom/index.lasso


What signatures are required? 

  • PI signature, required
  • If required, Division Chief, Center Director, or similar position
  • Department Chair
  • Dean’s Office

What does CCT require in order to begin review/ negotiation?

  • Protocol
  • Completed Service Request Form
  • Proposed agreement if provided by Sponsor


How is the agreement finalized?

  • PI will be informed of any significant agreement issues raised by the Sponsor or UM.
  • Issues are resolved through negotiation


What does CCT require in order to sign the agreement for UM? 

  • Completed, signed routing form
  • Sponsor indemnification letter (if not incorporated in agreement)
  • Budget and all appendices
  • IRB approval


Who sends the agreement to the Sponsor? 

  • Unless otherwise instructed by PI, CCT will return the agreement to the Sponsor as either fully executed or to await full execution by the Sponsor.  
  • When the agreement has been fully signed, CCT will provide a copy to the PI 


When can I begin enrolling study subjects? 

  • Study subjects may only be enrolled after the protocol has been approved by the IRB and the agreement has been signed by both UM and the Sponsor
Research
 

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