Thursday 20th May 2021, 2pm BST
The preservation of digital source data and associated study documents is a critical component of compliance with Good Clinical Practice and is the responsibility of sponsor, investigator and all third-parties engaged in the study conduct.
Presented by Russell Joyce, our interactive webinar introduces you to the guidelines, standards, regulatory requirements and expectations for the archiving and preservation of digital clinical research data and documents.
Russell will explore the evolving archiving environment, examining regulatory requirements expectations and measures to ensure inspection readiness; organisational responsibilities for archiving and preserving digital clinical research records and systems; and common regulatory in relation to the archives.
As the Director & Principal Consultant for Heath Barrowcliff Consulting Ltd., Director of the Health Sciences Records & Archives Association and a member of the TMF Reference Model Steering Committee, Russell has a wealth of knowledge in GCP data compliance.
What will I get out of the webinar?
By the end of the webinar attendees will better understand;
- Regulatory and GCP guidelines, standards and requirements as they relate specifically to the archiving and preservation of digital clinical research study records and source data.
- Responsibilities and accountabilities for digital archiving and preservation.
- The difference between records storage and digital preservation.
- The fundamentals of creating a digital archive.
- How to be better prepare for regulatory inspections.
Who should attend this webinar?
This webinar has been developed to support Archivists, Records Managers, Clinical Trial Administrators, Clinical Operations Staff, Quality Assurance Personnel or those who have a responsibility for creating, managing, archiving, and preserving clinical research data and documents within their organisation.
This webinar has now taken place but you can access the recording by completing the form below.
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