Course Description

Clinical Audits: Sponsor/Third Party Audits of Clinical Investigation sites

Course Description:

This course reviews the steps to prepare, conduct, and close out effective investigation site audits.

The content of this course is based on:

  • ISO 14155: 2011: Good Clinical Practice for Medical Devices
  • ICH-E6: Good Clinical Practice for Pharmaceutical Products
  • 21CRF 50 Protection of Human Subjects
  • 21CFR 54 Financial Disclosure by Clinical Investigators
  • 21CFR 56 Institutional Review Boards
  • 21CFR 812 Investigational Device Exemptions
  • 93/43/EEC Medical Device Directive
  • 90/385/EEC Active Implantable Medical Device Directive

Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Determine when an investigation site audit is required
  • Prepare an investigation site audit
  • Identify the relevant areas of facility, staff, clinical investigation conduct, and documentation to include in the audit
  • Write effective audit reports
  • Establish corrective and preventive actions where needed
  • Conduct closing activities, including close-out meetings

Who Should Enroll:

Clinical project managers, clinical research auditors, and quality assurance and regulatory managers interested in establishing an auditing system for clinical investigations or in preparing clinical investigation audits are all encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

The following material is required:

  • Extensive experience with medical device good clinical practice activities
  • A minimum of five years (preferably) in an active CRA or project management position in the medical device field
  • Clinical Audits: Fundamentals of Auditing Medical Device Clinical Evaluations (ID 217)

Subject Matter Expert:
Alodia Ruiz

66 min

Related resources:

Case studies:

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