4-Drug Nerve Block versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans
Technical Report,30 Sep 2015,29 Sep 2016
UNIVERSITY OF PITTSBURGH PITTSBURGH United States
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During the research period, all team efforts entailed the management of regulatory requirements. These included i Food and Drug Administration Investigational New Drug FDAIND Application, review, revisionresubmission, and approval, ii University of Pittsburgh Institutional Review Board IRB, iii VA Pittsburgh IRB, iv University of Pittsburgh Research Conduct and Compliance Office, v VA Pittsburgh Research and Development Quality Assurance, vi University of Pittsburgh Data Safety Monitoring Board, and ultimately vii DOD Human Research Protection Office HRPO review and approval. The FDA-IND process included the determination of safety of the 4-drug nerve block mixture these proceedings led to an accepted manuscript in a peer-reviewed journal. Throughout this time, all study-related infrastructural issues were addressed, managed, and finalized, including case report forms, computer-based data entry and management via the REDCap system, and formulation of the Manual of Operating Procedures.
- Medicine and Medical Research