Managing the Trial Master File - Considerations for Moving to Electronic TMFs

This clinical compliance training will review what issues one needs to consider if one’s organization is thinking about introducing an IT solution for the management of trial master file content. Attendees will gain an understanding of how to comply with the regulatory requirements that are pertinent to the maintenance of the TMF and how to choose efficient supporting TMF processes.

Why Should You Attend:

• Do you understand what regulations apply globally to the management of trial-related documents?
• Do you understand how those regulations should be interpreted when using electronic systems?
• Do you understand the different functionalities that are possible with electronic TMF systems and their potential impact on trial-related processes?

If you do not know the answer to one or more of these questions, then attending this one-hour webinar will help you improve your understanding of eTMF solutions.

This session will be introduced with an overview of the regulations that pertain to the management of trial documents. The instructor will then explore what differences exist in an electronic environment and identify the potential issues that are often overlooked. The introduction of eTMF technology offers a wide range of options so this webinar will be looking at how implementation can be optimized depending on the needs of your organization.

Learning Objectives:

At the end of this webinar, participants will understand what the regulatory requirements are for electronic TMF systems and will be able to describe what issues need to be addressed to develop an implementation strategy.

Areas Covered in the Webinar:

• Defining the trial master file.
• Understanding requirements for an electronic TMF.
• The importance of content classification and metadata.
• Options when using CROs and other third parties.
• Signing and approving documents.
• Hosting a regulatory inspection using an eTMF.
• Archiving and digital preservation.

Who will Benefit:

This webinar will provide valuable assistance to the following personnel:

• Clinical IT Project Managers
• Clinical Operations Management
• Clinical Project Managers
• TMF Specialists
• Records Managers
• Clinical Compliance Officers

Instructor Profile:

Eldin Rammell, is an independent records management consultant with over 25 years experience within the life sciences sector. Gaining experience within major pharmaceutical companies, he has managed on site and off site records centres and archives and overseen major records management projects. During the last 10 years, he has been the owner and principal consultant at Rammell Consuting Ltd, providing bespoke consultancy in clinical records management. He has been engaged as a consultant on several eTMF implementation projects for clients ranging from multinational pharmaceutical companies to small biotechnology companies. He is recognized as an industry key opinion leader in the area of TMF management and is a regular conference speaker.