Clinical Audits: Auditing the Clinical Research Organisation and the Sponsor
Reviews how to effectively review and qualify a CRO and establish a system to periodically monitor their performance as well as how to perform sponsor internal audits.
This course is based on the following rules and regulations:
- ISO 14155:2011 - GCP for medical devices
- ICH-E6 – GCP for pharmaceutical products (in so far that pharmaceutical products may be involved)
- 21CRF 50 Protection of Human Subjects
- 21CFR 54 Financial Disclosure by Clinical Investigators
- 21CFR 56 Institutional Review Boards
- 21CFR 812 Investigational Device Exemption
- 93/43/EEC and 90/385/EEC medical device and active implantable medical device directives.
Upon completion of this course, trainees will be able to:
- Identify the reasons that warrant an audit of a CRO
- Learn how auditors prepare for conducting a CRO audit
- Identify the relevant areas of the CRO organization that are to be included in the audit
- Set up an internal audit plan for auditing the clinical research department of a sponsor
- Write effective audit reports
- Identify corrective and preventive actions where needed
- Conduct closing activities including a closing meeting
Clinical project managers, clinical research auditors, ), quality assurance managers and regulatory managers, interested in establishing a quality audit system for clinical investigations and/or prepare for clinical investigation audits.
Extensive experience with medical device GCP activities, preferably a minimum of 10 years of active CRA position in the medical device area or project manager position in the medical device area. Experienced audit professionals that come from the pharmaceutical industry should ensure they master perfectly the regulatory requirements of medical devices as outlined in the course description above.