Professional Inquiries
The Clinical
Research Center includes physicians; registered-nurse study
coordinators; advertising, marketing and recruiting staff; regulatory
and financial staff; and administrative support personnel. The CRC has
performed and managed more than 200 Phase I, II, III and IV clinical
studies. The staff prepares protocols, informed consents and other
regulatory documents for submission to either the EVMS Institutional
Review Board or Chesapeake. Research Review, Inc., which is available
for proposed amendments. The Center creates and buys advertising,
recruits and screens volunteers, obtains informed consents, schedules
all office visits, performs tests and procedures and reports results to
sponsoring organizations.
Routine audits by
pharmaceutical sponsors and the U.S. Food and Drug Administration (FDA)
have resulted in praise for the CRC's overall conduct of studies,
subject retention, record-keeping and drug accountability.
The Clinical
Research Center can support other clinical research by providing
consultation on study design and development of protocols and informed
consents. The CRC provides experienced staff who manage all aspects of
research studies, from recruiting patients and handling biological
specimens to coordinating the study and entering data with post-study
follow-up. |