Thursday 24th June 2021, 2pm BST
Presented by Russell Joyce and Matthew Addis, this educational webinar examines 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 webinar is 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.
What will I get out of the webinar?
By the end of the webinar attendees will better understand;
- How to create archives that are fit-for-purpose in the digital era and compliant with regulatory requirements.
- Improve the integrity, trustworthiness, and reliability of archived data and documents.
- The challenges presented by the variety and complexity of digital records and the additional considerations needed to archive these to ensure their continuing accessibility, readability, and usability.
- Practical solutions for improving digital archiving policies and procedures.
- Exploit opportunities for enhanced information sharing and improved collaboration through the use of digital preservation technologies.
Who should attend this webinar?
This webinar has been developed to support Archivists, Records Managers, Clinical Trial Administrators, Clinical Operations Staff, Quality Assurance Personnel and those involved in 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.
27 Apr, 2021
FAIR data principles, what are they and how can they support compliance?
Life Sciences organisations are becoming big data enterprises, generating large amounts of data from clinical studies, lab equipment and drug development. However, this plethora of data is…
20 Apr, 2021
Neuraly Case Study: Helping a revolutionary clinical-stage biotechnology company become GCP compliant
You can access the full Neuraly case study here. With two clinical studies in Phase II and three more in pre-clinical stages, Neuraly – a clinical-stage biotechnology…
13 May, 2021
New eBook: A Guide to Archiving Laboratory Data
The long-term archiving of digital raw data is critical to ensure compliance with Good Laboratory Practice (GLP), to meet the requirements of data integrity guidance issued by…