Saint Luc Clinical Coordinating Center

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  • Approval Process
  • Protocol procedures
  • Drug administration / device use
  • Safety issues
  • When the study site identifies potential patient, they will contact the CCC by phone
  • Investigators or study coordinator will call the CCC for patient approval.
  • CCC physician review eligibility criteria with study site.
  • Study site will provide CCC physician with specific information necessary for approval.
  • 100 % authorization by a CCC physician

Clinical Coordinating Center will follow-up the study site to assure site compliance with protocol.

Study site should refer to the sponsor for questions regarding study drug issues (i.e. damageal kit - drug supply).

Safety issues can be discussed with a CCC physician. We will notify the sponsor.

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