The overall purpose of the CRO is to provide a centralized service to facilitate protocol handling and to rigorously support clinical research trials for the members of CINJ. The specific objectives of this shared resource are as follows: (1) to submit, activate, update, amend, and summarize protocols and regulators to the regulatory agencies; (2) to communicate the status of clinical trials to all CINJ investigators and affiliates (3) to screen and identify eligible patients for clinical studies; (4 to facilitate enrollment of patients onto clinical trials; (5) to schedule appropriate tests, treatments, and assessments; (5) to collect, verify, and record results; and (7) to ensure compliance with Good Clinical Practice guidelines and the regulations of applicable regulatory bodies. The clinical research enterprise at CINJ is new; there were no organized clinical research activities before 1993, and the vast majority of clinical faculty were recruited since 1995. As patient volumes and number of active studies increased the usage of the CRO accelerated. During the period from January 1, 1996 through December 31, 1998, there were 1,309 protocol entries (650 were onto therapeutic trials, 78 were onto supportive care trials and 581 were onto other studies). Three hundred sixty-four of the 650 (56%) of the therapeutic trial entries were onto investigator-initiated trials, and 100% of the accrual to the """"""""other trials"""""""" category were investigator initiated.
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