Introductory Course on Auditing Investigator Sites
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| 08/09/2025 | Introductory Course on Auditing Investigator Sites | Brussels | EUR 1775 | Book |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
This auditing investigator sites course will cover the history and current context of GCP QA auditing, selection of investigator sites for audit, preparation and conduct of investigator site audits, audit report writing and follow-up, CAPA plans and metrics. One session will be devoted to trouble-shooting and practical aspects, including communication. There will also be several practical exercises.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
We provide this course in two distinct formats: Classroom OR OnlineClassroom: 2-Day face-to-face: 09:00 - 17:00 | Online: 4 webinar sessions of 3 hours |
Course Description
You want to know more about auditing and/or the techniques used in GCP-auditing?You do not see the difference between quality assurance and quality control?This auditing investigator sites course is designed to provide a basic understanding of the Good Clinical Practice (GCP) audit process in clinical drug development and to demonstrate the importance of audits in ensuring good data quality. It will include practical tips when conducting an audit.An overview of quality management, quality assurance and quality control in clinical research will be presented. The role of investigator site audits in this context will be highlighted, as well as the application of current auditing standards, such as ENGAGE and ISO 19011. All steps involved in the audit process - planning, conduct, documentation, follow-up and close-out - will be explained. General expectations and specific requirements from GCP auditors as well as qualification requirements for auditors are included.Programme highlight
- Quality and audit concepts
- Current auditing standards
- Different approaches to planning and conducting investigator site audits
- Reporting audit findings
- Audit follow-up and CAPA plans
Learning objectives
- Understand the importance of investigator site audits within the quality assurance system
- Differentiate the various types of investigator site audits
- Be familiar with applicable audit standards
- Know the data requirements specific to GCP audits
- Prepare for investigator site audits
- Conduct investigator site audits
- Evaluate observations and write audit reports
- Know the importance of audit follow-up / CAPA plans
- Recognize GCP audits as a method of ensuring data quality
Who should attend
This course is designed for clinical research professionals with previous working experience in a GCP or in a Quality Assurance environment and who wish to understand how to conduct an investigator site audit.
Auditing experience is not required.Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (2)
- Investigational Product Development and Regulation (4)
- Clinical Studies Operations (GCPs or ISO 14155) (4)
- Study and Site Management (2)
- Data Management and Informatics (2)
- Leadership and Professionalism (1)
- Communication (1)
- Teamwork (0)
- Business acumen (0)
Trainers
Katharina Stolar
Octapharma
Good introduction for people new in this field - received lots of good advice for future conduct of Audits and Audit Report writing, as well as helpful advice on how to prepare for Audits - very satisfied - I would like to thank the Trainer for this great course and hope to see her in future courses.
Els Tassenoy
AML Research
Anonymous
EyeD Pharma
Diletta Ricci
GLPG