Clinical Investigator Resource Core (CIRC) (Center for Translational Medicine)

Guidance in meeting regulatory requirements for clinical research.General information or brief consultation regarding availability of resources and services to support clinical and translational research. Connections to potential mentors, collaborators, and research resourcesPre-review of investigator-prepared regulatory documents: a review of all draft documents prior to submission to the IRB to ensure that they are complete, correct, and consistent. A Pre-Review usually takes less than 2 business days and typically results in a significant decrease in time required to attain final approval of the protocol. (please log in to the eIRB site for access to Pre-Review).
Preparation of regulatory documents for submission to the IRB and the sponsor.Preparation of, or guidance concerning, budgets for research studies.
(increased fee structure; time estimates vary depending upon the complexity of the protocol.)
Preparation of/comprehensive consultation regarding an IND or IDE to the FDA.Protocol development and consultation.Preparation of study initiation documents.Preparation of regulatory binders.Preparation for an audit.Other complex regulatory activities or filings.