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Fedor, Carol; Ferrazzano Yaussy, Cristina; Cola, Philip A. – Journal of Research Administration, 2008
Recent trends in Human Research Protection Programs (HRPPs) have contributed to the rising emphasis on prospective monitoring of clinical research and education programs. Therefore, internal efforts and resources to monitor investigator compliance and site performance have become an important focus in the conduct of clinical research. Once the…
Descriptors: Compliance (Psychology), Research Administration, Evaluation, Professional Continuing Education
Fedor, Carol; Cola, Philip; Polites, Stephanie – Journal of Research Administration, 2007
The reporting, analysis, and management of adverse events (AEs) provide an ongoing assessment of risk in the context of a clinical trial and enhance the protection of human research participants and the informed consent process. Effective and efficient review of AEs has been a long-standing challenge for Institutional Review Boards (IRBs) and…
Descriptors: Medical Research, Research Administration, Patients, Participation