Clinical Research Organization Audit for Good Clinical Practice

Why Should You Attend:

A Contract Research Organization (CRO) has specific responsibilities in auditing a clinical study for conformance with the applicable Good Clinical Practice (GCP) regulations. The CRO is required to certify conformance with the study design, conduct of the work, accuracy of recorded data and information, analysis of results and reports to FDA. CRO audits ensure that the study data and results are credible and accurate, and that the rights and well-being of study subjects have been protected. CRO audits also identify needed corrective and preventive actions. Government regulation of GCP protects human subjects who participate in clinical studies. FDA publishes specific GCP regulations based on the laws enacted by the Congress (amendments to the FD&C Act). These laws make the protection of clinical study subjects the joint responsibility of four independent parties, each with specific obligations:

• Product Sponsor
• Institutional Review Board
• Clinical Investigator
• FDA

Areas Covered in the seminar:

• Pre-study Requirements and Start-Up:
  • Study Protocol
  • IRB
  • Investigator and Staff Credentials
  • Site Inspection
  • Control of Drug or Product
  • Data Management
  • Regulatory Binder
  • Standards of Procedures Binder
• Ongoing Study Requirements:
  • Significant Safety Reports (Adverse Events)
  • Protocol Amendments
  • IRB Updates
  • Correspondence
  • New Safety Data
  • Monitor Visits (Case Report Forms Review)
  • Regulatory Binder Updates
  • Standards of Procedures Updates
• Close-out Study Requirements:
  • Safety Data Report
  • Final IRB Report
  • Study Protocol Compliance
  • Correspondence
  • Data Management
  • Monitor Visits (Case Report Forms Review)
  • Record Retention Requirements
  • Possible FDA Inspection
  • NDA/PMA Filing Status
  • Drug or Product Supplies

Who will benefit:

• Executive Management (Sponsor)
• Sponsor Supported CRO
• Regulatory Compliance Managers
• Project and Program Managers
• Product Development, R&D and Engineering Managers
• Internal Auditors (Sponsor)
• Quality Assurance Risk Management Manager
• Information Technology/Data Management Personnel

Instructor Profile:

Ron Schoengold, is a private consultant to the biotechnology and medical device industry, offering the most current quality, technical and business information on how to commercialize and maintain medical products in a competitive environment. An active contributor to the industry for over 40 years, Ron has developed commercially successful screening and diagnostic products for gastroenterology, infectious disease and point-of-care testing. He serves as an advisor for the Larta Institute which is supported by the National Institutes of Health Commercialization Assistance Program to help companies awarded SBIR grants. Ron has published, presented or contributed to more than 16 scientific journal articles, co-authored a book chapter on point-of-care testing and holds 8 patents related to point-of-care diagnostics. He earned his bachelor’s degree in biology and chemistry did his graduate studies in microbiology, biochemistry, genetics, molecular biology and immunology.

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