The Protocol and the Investigator Brochure are submitted directly to the University of Cincinnati Medical Center Institutional Review Board (UCMC IRB). The dermatology clinical research team develops the informed consent statement, and works closely with the Sponsor/CRO to insure that the consent statement includes all elements required by the Sponsor, while meeting the requirements of the UCMC IRB. The UCMC IRB meets on Wednesdays and has a turn around time of approximately 21 working days.
The contract is reviewed by Mr. Bill Walker, Business Administrator for DCRC, and by attorneys from the University of Cincinnati Office of Intellectual Properties. These representatives work closely with legal representatives from the Sponsor/CRO so that contract negotiations can be completed in a timely manner.
