This webinar will cover regulatory requirements for archiving clinical trial documents, both paper and electronic records. It will focus on the key components of a digital preservation strategy to ensure the ongoing retrievability and accessibility of clinical trial electronic records.
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.
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
Course Provider
Eldin Rammell,
