Practical Approaches to Digital Preservation for TMF & GCP Data
Watch the recording of the session below
This educational session examined practical approaches for the successful archiving and preservation of clinical research source data and documents. The preservation of digital source data and associated study documents is a critical component of compliance with Good Clinical Practice (GCP) and the responsibility of both sponsor, investigator and all third-parties engaged in study conduct.
The purpose of this presentation was to identify the challenges presented by the variety and complexity of digital records; discuss additional considerations needed to archive these to ensure their continuing accessibility, readability, and usability; explore practical solutions for improving digital archiving policies and procedures; and provide guidance on how best to address the challenges presented by “the ticking clock” of digital ephemerality.
Speakers: Matthew Addis, CTO and Founder, Arkivum Russell Joyce, Director, HSRAA and Director, Heath Barrowcliff Consulting Ltd