Core--Clinical research support

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Description: (Applicant's Description) UPCI Clinical Research Services provides the central resource for (1) assisting, principal investigators in protocol composition, consent form construction and protocol summary development; (2) submission of protocols to UPCI Protocol Review Committee, Institutional Review Board (IRB) and General Clinical Research Center (GCRC) Advisory Committee; (3) submitting investigator IND applications to FDA; (4) providing data management and coordinator for all UPCI clinical trials, (5) overseeing external reviewers site visits and audits; (6) assessing UPCI recommended patient availability for new studies; (7) evaluating clinical research costs associated with new studies and (8) assisting principal investigators in research development budgets for externally supported trials. This central UPCI resource provides the infrastructure for development, conduct, and oversight of all UPCI clinical research studies.