69.00€
In the “Guidelines, Regulations, and Tools Related to Trial Master File” course, you will learn based on which regulations we work with clinical documentation. How the approach to TMF has changed over time, and what conclusions have various legislation has ultimately reached about document management.
Well, because that documentation is not an inseparable part of clinical research we know, but basically what legal basis do we have for it? This is what you will learn about in the course.
With the basic idea coming out of the regulations being the proper care and oversight of the TMF with constant preparation for inspections, the course will also discuss the tools required for this purpose. You will learn how to properly set up the TMF not only in the study, but also in the entire organization using the TMF Reference Model, and how the Expected Document List or milestones help us.
After completing this course, you will be able to properly oversee and monitor TMF Completeness, TMF Timeliness, and TMF Quality. You will know how to use available KPIs, and metrics, and which reports to use when evaluating TMF Health at different levels – from the site to the study, to entire departments or the organization.
Do you want to manage TMF effectively and be TMF Inspection Ready at all times, but don’t quite know how? This course is for you!
She has been involved in the clinical research industry since 2015. She currently works for a global pharmaceutical company as a Manager in the Clinical Documentation team, where her main role is FSO Operations Lead.
She places high value on personal development and the quality of performed activities, which makes her a valued member of project teams. She has operational experience gained in global CROs and pharmaceutical companies. She has worked on both investigational and medical device projects in a variety of therapeutic areas.
From the very beginning of her work in clinical research, she has struggled with the complex nature of clinical trial documentation and TMF, which she continues to explore to this day.
In addition to her day job, she is actively involved in the academic community, initially as a coordinator and support to the manager of a post-graduate study in the clinical trial area. Currently, she is a lecturer at Conducting and Monitoring Clinical Trials and a manager of postgraduate study Project Management in Clinical Trials.
This collaboration started after the previously completed postgraduate studies in Conducting and Monitoring Clinical Trials. Graduate of Nicolaus Copernicus University in Torun in the faculties of molecular biology and environmental protection.
Although she started her professional life at the Central Forensic Laboratory of the Police, she now finds herself perfectly at work in clinical project activities and now she is conducting other types of investigations.
Don’t miss out on this opportunity to revolutionize your employee development process with AIDIFY’s freemium license. Fill out our form to get started today!
Reviews
There are no reviews yet.