Retention for study records today includes electronic CRFs and electronic source data at the sites as well as in the sponsor's Trial Master File. Proper indexing and handling of media for long term retention is new to many investigator study teams.
This workshop builds awareness for e archive practices needed to preserve electronic raw data from studies. The need to recreate study results from long retained data is a regulatory requirement for GCP trials. System backup media do not constitute an electronic archive. There is a science to good archive practices in this workshop we explore them.
I. Defining the Purpose, Scope, and Structure of an Electronic Archive
· What is an electronic archive and why is backup media not an electronic archive?
· What is the OECD Guidance approach to archiving and electronic archives?
· Analysis of SOP topics from OECD for establishing an archive
· Defining the role of the Archivist vis-à-vis the IT function supporting an electronic archive
II. Archiving Principles, Archivist Values, and The Electronic Document Difference
· Provenance, Original Order, Indexing, and Catalogue
· Record collection and retention values and best practices
· Scale, Mutability, and Readability
· Needs Analysis for planning a long term retention requirements specification
III. Interactive Exercise
· Archivist Team: Discuss and document a hypothetical “AS IS” analysis report of your group’s companies using the Requirements Specification section of Chapter 9, pp 303-304.
· IT Team: Discuss a hypothetical plan for IT to use to design the infrastructure for an e-archive in a small to medium company using the 13 points quoted in Chapter 9, p 305-307.
· QA Audit Team: Discuss the OECD topics for Archival SOPs.
1. Decide how these should apply to Archive Staff and also to IT Staff.
2. What quality evidence will you look for in an audit of an electronic archive for each department based on this SOP framework?
Workshop Material Chapter 9: The Archivist Role for Electronic Archives in Teri Stokes "Computer Validation: A Common Sense Guide". Organisation for Economic Cooperation and Development (OECD) 2007 Guidance – "Establishment and Control of Archives that Operate in Compliance with the Principles of GLP"