The 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.
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 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.
Course time09h00 - 17h00
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.
- 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
- 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
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)
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