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Course: Introduction to Digital Preservation / Archiving
Date: 30 March 2021 (2 hours)
Location: Virtual Classroom
Price: £75 plus VAT

Duration: 2 hours
Course Description:

An introduction to digital preservation including expert insights into practical approaches for the archiving of clinical research data and documents.

The retention and archiving of study records and source data, is a critical component of compliance with Good Clinical Practice and the responsibility of both the study investigator and the sponsor. The maintenance and retention of those study records is essential to ensure that a study can be reconstructed and that the data generated and outcomes reported can be verified.

The requirements for archiving digital records are no different to those for physical records but the variety and complexity of digital records requires additional considerations. The purpose of this seminar is to identify and discuss these considerations and to provide guidance on how best to address the challenges.

This event is designed to be complementary to the NHS R&D Forum Archiving Master class with a focus on digital archiving and preservation only. For further details of the full master class link herehttps://rdforum.nhs.uk/open-course-details/?id=3229

Speakers

Russell Joyce

Russell began a varied career in Records Management and Information Governance working for the City of London Police and Serious Fraud Office at the height of the infamous Maxwell and Guinness investigations, since when he has gained valuable experience in banking, professional services, the legal sector, the NHS, and pharmaceuticals. In 2012, Russell established Heath Barrowcliff Consulting Ltd, a wholly independent consultancy specialising in records management and information governance in GCP, GDP, GLP and GMP in the life sciences sector with a focus on evidential value, data integrity, digital archiving, and the exploitation of technologies to maximise operational and financial efficiencies.

Russell is a Director of the Health Sciences Records and Archives Association (HSRAA), an active member of the Drug Information Association (DIA) TMF Reference Model Group Steering Committee, and Project Lead for the DIA Non-Interventional /Real World Studies TMF Model Project. He has spoken extensively on records management and information governance for HSRAA, GCP-RMA, SMi Group, DIA, the Research Quality Association, the Pharmaceutical Quality Group, ISPE/GAMP, the Institute of Clinical Research, and the NHS R&D Forum.

Dr Matthew Addis

Co-Founder and CTO. Digital preservation Technical lead

Matthew is CTO and Founder of Arkivum, responsible for technical strategy. Matthew previously worked at the University of Southampton IT Innovation Centre. Over the last fifteen years, Matthew has worked with a wide range of organisations in the UK, Europe and US on solving the challenges of long-term data retention and access.

Matthew’s expertise includes digital preservation strategies, system architectures, total cost of ownership, how to mitigate the risk of loss of critical data assets and building business cases for both compliance and asset value scenarios.

Who is the Course for?

This seminar has been developed to support Research Management Teams, Named Archivists, Clinical Trial Administrators, Information Governance leads, Sponsor representatives and all those with responsibility for archiving and preserving research records within their organisation.

As with all Forum activities it is also a valuable opportunity to meet with colleagues from across the country to share ideas and experiences, and to discuss challenges and solutions.

Event Structure

A ninety-minute presentation delivered by archiving and digital preservation professionals with expertise taking participants through the key considerations needed to ensure ongoing accessibility, readability, and usability of digital data and records throughout the duration of their required retention period.

Agenda

An introduction to e archiving, GCP and digital preservation processes.

The first half of the event will include an introduction to digital archiving and an exploration of preparation required plus process optimisation. (Russell Joyce)

Technical aspects

The second half will cover an examination of the technical aspects, challenges and solutions possible, and the long-terms benefits of bona fide digital preservation vs simple digital storage. (Matthew Addis)

Q&A and open discussion

Q&A plus open discussion and round up

Learning Objectives:

Objectives

By the end of the session participants will better understand:

  • Regulatory and GCP requirements as they relate specifically to the archiving and preservation of digital clinical research study records and source data;
  • The difference between records storage and digital preservation;
  • The basics of creating a digital archive
  • The challenges presented by the variety and complexity of digital records the additional considerations needed to archive these to ensure their continuing accessibility, readability, and usability;
  • Organisational responsibilities for archiving and preserving digital clinical research records and systems;
  • Practical solutions for improving digital archiving policies and procedures; and
  • Be better prepared for regulatory inspections.

Back to course listing

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