4-Drug Nerve Block versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans

Abstract

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, revision/resubmission, 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.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2016
Accession Number
AD1034090

Entities

People

  • Brian A. Williams

Organizations

  • University of Pittsburgh

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Analgesia
  • Anesthesia
  • Drug Abuse
  • Employment
  • Health Services
  • Medical Personnel
  • Peripheral Nervous System
  • Therapy

Readers

  • Clinical Trial Research.
  • Neurotrauma and Rehabilitation Medicine.