Clinical Audits: Auditing the Clinical Research Organisation and the Sponsor
Course Description:
This course outlines the Clinical Research Organizations (CRO) review and qualification process and demonstrates how to conduct sponsor-based internal audits and establish a system to periodically monitor the organization’s performance.
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 what factors warrant a CRO audit
- Understand how auditors prepare for conducting CRO audits
- Identify the relevant CRO areas to include in the audit
- Set up an internal audit plan for a sponsor’s clinical research department
- Write effective audit reports
- Establish corrective and preventive actions where needed
- Conduct closing activities, including a closing meeting
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 welcome 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 ten years (preferably) in an active CRA or project management position in the medical device field
- Expert knowledge of the medical device regulatory requirements outlined in the course description above (applies to experienced auditing professionals from the pharmaceutical industry only)