The course will cover writing clinical development audit reports using investigator site audits as the basis. Reports for other types of audit will also be addressed.
The key to this training will be a practical approach, including exercises, to improve communication of audit findings.
This 1-day course is designed to improve the way you present your audit findings.
The audit report is your "deliverable" and should document what you did and what you found during an audit. It should be clearly and accurately written so that it is understandable and acceptable to the auditees. There also needs to be consistency between auditors within an audit department.
None of these is easy to achieve!
This course is designed to help you get your messages across to your "customers" in a clear and consistent manner.
Course time09h00 - 17h00
Who should attend
This course is designed for clinical quality assurance professionals who wish to improve the quality of their audit reports.
Previous GCP auditing experience is required.
- Structure and content of audit reports (ISO 19011:2011)
- Audit observation writing
- Audit observation grading
- Consistency across auditors / audit reports
- Follow-up and evaluation of CAPA plans
- Practical exercises
- Understand the importance of communicating audit results clearly
- Develop the structure of an audit report
- Write clear and concise audit observations
- Improve consistency in reporting between different auditors
- Evaluate auditees proposals for CAPAs
- Deal with misunderstandings and misinterpretation of audit reports
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained