An Overview of Clinical Archiving. Russell Joyce Records & Information Manager

Transcription

1 An Overview of Clinical Archiving Russell Joyce Records & Information Manager

2 Objectives To understand the Historical context of archiving Importance of archiving Regulatory & legal frameworks Archiving challenges Meeting archiving challenges ICR/SAG Conference 11th February

3 Historical Context Etymology 1. Derived from the Greek word ἀρχή (arkhē) meaning government or order (e.g. anarchy, monarchy) and ἀρχεῖον (arkheion), the home of the Archon, in which important official state documents were filed and interpreted under the authority of the Archon. ( History 1. Archives were well developed by the ancient Chinese, Greeks and Romans. Definition of archive 1. Documents or records related to the activities, business dealings, etc. of a person, family, corporation, association, community, or nation. 2. Any extensive record or collection of data 3. A collection containing records, documents, or other materials of historical interest. ( ICR/SAG Conference 11th February

4 Historical Context Medicines Development Incident driven (e.g. Thalidomide) Increasing legislative environment Increasing regulatory environment ICR/SAG Conference 11th February

5 Importance of Archiving Reasons to archive Legal reasons Regulatory reasons Commercial reasons Historical reasons Accountability reasons ICR/SAG Conference 11th February

6 Importance of Archiving Responsibilities Senior Management Information Technology Individual Employees The Archivist! ICR/SAG Conference 11th February

7 Regulatory & Legal Frameworks Documents (Definitions) Documents that individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data produced, are defined as essential documents according to CPMP/ICH/135/95 Information (recorded in any format or medium) created, received, and maintained as evidence and information by an organisation or person, in pursuance of legal obligations or in the transaction of business. (ISO : 2001) All records, in any form, (including, but not limited to, written, electronic, magnetic, and optical records; and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct and/or results of a trial, the factors affecting a trial, and the actions taken (ICH GCP 1.23) Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (ICH GCP 1.22) ICR/SAG Conference 11th February

8 Regulatory & Legal Frameworks Retention Must be retained for sufficient periods to allow for audit and inspection by regulatory authorities and be readily available. Documents serve to demonstrate compliance and monitor standards Retain trial documentation for at least 5 years after trial conclusion (Commission Directive 2005/28/EC Article 17; SI 2006:1928; SI 2004:1031) Retain all other documentation pertaining to the trial as long as the product is authorised. (EU Directive 2003/63 Annex 1) Personal data subject to elements of EU Directive 95/46/EC and UK Data Protection Act ICR/SAG Conference 11th February

9 Archiving Challenges Ready Availability Records must be readily available, upon request, to the competent authorities. (EU Commission Directive 2005/28/EC Article 17) Access must be restricted only to authorised personnel. ICR/SAG Conference 11th February

10 Archiving Challenges Storage Preferably purpose built weatherproof space Appropriate environmental controls Protection from fire, flood and pests to prevent deterioration May be transferred to a sub-contractor (CPMP/ICH/135/95, 5.2.1) The investigator should inform sponsor of archive facilities at investigator sites ICR/SAG Conference 11th February

11 Archiving Challenges Electronic Records Potential file format obsolescence Potential software obsolescence Potential hardware obsolescence Potential operating system obsolescence Media deterioration ICR/SAG Conference 11th February

12 Meeting Archiving Challenges Ready Availability Catalogue accurately to ensure ready availability (e.g. Compound & Study ID; Department; Classification; Meaningful Description) Document procedures in SOPs (receipt, registration; maintenance; loans & destruction) File documents to facilitate trial management, audit and TMF inspection Set up TMF plan at trial start and maintain throughout the trial. Factor archiving costs in trial design phase ICR/SAG Conference 11th February

13 Meeting Archiving Challenges Storage Remove all non-paper items from documents Evaluation & audit of premises Periodical checks to ensure compliance & maintenance of standards Requirements mandated in contract Business continuity plan ICR/SAG Conference 11th February

14 Meeting Archiving Challenges Electronic Records Archiving in native format maintains metadata and enables re-use Archive in non-proprietary format may loose metadata & prevent re-use ISO : 2005 Electronic document file format for longterm preservation Validate when archiving to another system (EudraLex Vol 10, Chapter 5) ICR/SAG Conference 11th February

15 Meeting Archiving Challenges Retention Schedule Define the classification of documents Records relevant date for retention purposes Ensure consistent & systematic application of retention periods ICR/SAG Conference 11th February

16 Meeting Archiving Challenges Standards & Training Qualified or experienced staff Train staff Accurate job descriptions, goals & development plans Utilise guidance e.g. MHRA Guidance Advice SAG Guidance on the Archiving of GCP Materials! ICR/SAG Conference 11th February

17 When things go wrong ICR/SAG Conference 11th February

18 When things go wrong ICR/SAG Conference 11th February

19 When things go wrong ICR/SAG Conference 11th February

20 When things go wrong ICR/SAG Conference 11th February

21 Further Reading (References) ICR/SAG Conference 11th February

22 Further Reading ICR/SAG Conference 11th February

23 Questions ICR/SAG Conference 11th February