Clinical Research Center
Established September 1, 2009, the School of Medicine Clinical Research Center (CRC) was developed for facilitating investigator-initiated research involving full-time Faculty, Fellows, Residents and Medical Students. Projects can include trials with patients, chart reviews, surveys, etc. The CRC staff will provide assistance in defining projects, developing experimental protocols, preparing budgets, developing IRB submissions and conducting the study, as well as providing training at each step.
Experience
Our office has experience in conducting Phase I through Phase IV pharmaceutical and device, industry-sponsored, as well as investigator-initiated research protocols.
Services
Marketing
- Match making between Sponsors and Investigators
- Developing/maintaining relationships with outside organizations
- Consultation on protocol development and execution according to ICH/GCP guidelines.
Project Management
- Contract negotiation and execution
- Negotiations and preparation of study budgets
- IRB preparation and submission
- Clinical research coordination by highly qualified, trained coordinators and Registered Nurses.
- Account Management
Education
- Clinical Research Coordinator training
- Investigator training
- Student training
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"Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethic of research involving human subjects: the principles of respect for persons, beneficence and justice."
~Belmont Report 1979 |