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.
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.
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
Course Provider
Eldin Rammell,
