Summary
In this course, you will get a thorough understanding of audits and inspection processes. You will learn how you as site staff and sponsor can prepare to ensure a successful outcome and what it takes to be audit and inspection ready. We will discuss who should attend, what the roles and responsibilities are, and how you can present your procedures and documentation in the most optimal way to avoid misunderstandings during the audit/inspection process. We will also look into reports, what the most common findings are, and how they are presented.
Keywords
- Audit and inspection ready
- Roles and responsibilities
- Findings/classification of findings
- CAPA
- Opening and closing meetings
- Dos and don’ts in audits and inspections
IS THIS COURSE FOR YOU?
This course is relevant if you work as a study nurse, an investigator or a study coordinator at a clinical site.
You will also benefit from the course if you are a
- Clinical Research Associate
- Clinical Trial Monitor from GCP units or Clinical Research Organistions
- Clinical Auditor with limited inspection experience.
What you will learn
- The background and the difference between audits and inspections and the impact of the outcome
- The tools to help you stay audit/inspection ready
- The roles and responsibilities of the key players in an audit/inspection
- To understand the interview techniques and how to respond in a clear and concise way
- How to present electronic data without compromising GCP and data protection
- How to create a team that can work together to achieve good results
What your company will get
- An employee who can contribute to create a successful audit/inspection outcome
- An employee who understands the roles and responsibilities of the key players in an audit/inspection
- An employee who understands the benefit of a successful outcome and the risks of the opposite
Course calendar
DAY 1
- Background and definitions of audits and inspections
- Audit/Inspection preparations - Setting the Team - Logistics & Practicalities
- Input from an Inspector
- Handling the audit/Inspection
- Input from Study Site
- Follow up on Audits and Inspections
- How to stay Audit and Inspection Ready
- Cases
Registration
Registration deadline2. Feb 2022
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarize yourself with the mandatory readings before starting the course.
Prerequisites
To enroll in this course you must have at least one year of experience working with Good Clinical Practice in clinical trials.
Having a diploma in GCP is an advantage, but not a requirement.
Examination
There is no examination for this course.
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WANT TO KNOW MORE or need help?
Contact Client Manager Christina Spangsberg at +45 39 15 09 22
Send me a message