Regulatory

Manager: Kelly Shaffer, M.S.

The Clinical Research Office offers regulatory services for both industry-initiated and investigator-initiated research projects.  The goal of our program is to conduct clinical trials of the highest quality standards, and we welcome collaboration with investigators.

Our experienced and dedicated staff is available to assist investigators in all aspects of conducting clinical studies, from developing the protocol to closing the study.  Regulatory services include: helping develop protocols for investigator-initiated studies, preparing IRB submissions throughout the study, helping investigators register their trial at ClinicalTrials.gov, and preparing IND applications.  For sponsored clinical research, we also help with coordinating site selection and initiation visits, filing regulatory documentation with sponsors, preparing study budgets, and coordinating study monitoring visits.