Archiving Clinical Trial Documents - Understanding Regulatory Requirements for Paper and Electronic Records

Why Should You Attend:

• Do you understand what regulatory inspectors understand an archive to consist of?
• Do you understand what controls need to be in place for trial documents to be considered to be “archived”?
• Do you understand how to guarantee retrievability and accessibility of electronic documents long after the software that created them exists and for as long as those records are retained?

If you do not know the answer to one or more of these questions attending this one-hour webinar will help you to be better informed requirements for archiving.

This session will be introduced with an overview of the regulations that pertain to archiving of trial documents, including getting clarification on some of the key terminology used. We will then explore specific aspects of establishing and managing archives and how we can effectively meet the expectations of regulatory agencies. Managing electronic documents introduces an additional level of complexity due to the potential obsolescence of hardware, software and operating systems and the natural degradation of electronic storage media. We will look at strategies for mitigating these issues.

Learning Objectives:

At the end of this webinar, participants will understand what the regulatory requirements are for archives and archival processes and will be able to describe the key components of a digital preservation strategy to ensure the ongoing retrievability and accessibility of electronic records.

Areas Covered in the Webinar:

• Defining an archive, an archivist and archive processes
• Determining appropriate retention times
• Regulatory expectations for archives
• Security and access control
• Preservation of records
• Electronic archiving
• Digital preservation strategy

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
• Archivist
• 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.

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