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Regulatory Knowledge & Support

Regulatory & Compliance Consultation Services

IND/IDE Support

  • Assistance with filing and maintaining investigator-initiated IND/IDE applications with FDA

IRB Assistance and Liaison Program

  • Assistance with IRB submissions (initial and ongoing)
  • Assistance with ongoing IRB filings (adverse event reports, amendments, etc.)
  • Assistance with informed consent forms
  • Certified translations for informed consent forms
  • Liaison to COMIRB and the UCH Research Support Services (UCH RSS)
  • Assistance in navigating through multiple internal and external scientific and regulatory review and approval entities

Monitoring and Auditing

  • Provision of study financial tracking and oversight services
  • QA/QI Oversight Program

Protocol Development

  • New project consultation; assistance in translating a research idea into a complete research proposal with all required documents
  • Study development/design of clinical research protocols
  • Ethical protocol design
  • Review of all new protocol applications to assure compliance with IRB, NIH, and other regulatory agencies

Regulatory Management and Compliance Support

  • Assistance with or maintenance of regulatory binders
  • Assist in the development of multi-site protocol management
  • Assistance with or coordination of research audits (FDA, OHRP, and other agencies)
  • Assistance with or coordination of sponsor site visits
  • Assistance with safety report to IRB and regulatory authorities (US and international)

The following Standard Operating Procedure templates for compliance with Food and Drug Administration regulations and Good Clinical Practice guidelines for clinical trials involving drugs, biologics, or devices, published by the Thomson Center for Clinical Research Practice, Inc are available upon request. Please contact one of the RSAs for further assistance.

Available templates:
  • Standard Operating Procedures for Good Clinical Practice at the Investigative Site
  • Standard Operating Procedures for Good Clinical Practice by Sponsors of Clinical Trials
  • Standard Operating Procedures for Good Clinical Practice by Sponsors of Medical Device Clinical Trials

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