Contents

Disclaimer

Oxford University Press makes no representation, express or implied, that the drug dosages in this book are correct. Readers must therefore always check the product information and clinical procedures with the most up to date published product information and data sheets provided by the manufacturers and the most recent codes of conduct and safety regulations. The authors and the publishers do not accept responsibility or legal liability for any errors in the text or for the misuse or misapplication of material in this work. Except where otherwise stated, drug dosages and recommendations are for the non-pregnant adult who is not breastfeeding.

Show Summary Details
Page of

Archiving 

Archiving
Chapter:
Archiving
DOI:
10.1093/med/9780199608478.003.0023
Page of

PRINTED FROM OXFORD MEDICINE ONLINE (www.oxfordmedicine.com). © Oxford University Press, 2021. All Rights Reserved. Under the terms of the licence agreement, an individual user may print out a PDF of a single chapter of a title in Oxford Medicine Online for personal use (for details see Privacy Policy and Legal Notice).

date: 15 January 2021

This chapter discusses the importance of archiving the data. As well as regulatory advice the requirements of the most useful reference guide, ISO11799, is reviewed. Practical advice on issues such as location, storage, security, and environmental controls is given. The management of the archive from preparation to transfer of data is described. Methods of indexing and cataloguing together with tracking are detailed and systems for retrieval of data are explored. The role of the archivist in audits and inspections is discussed as the content of the TMF will be assessed during audit to ensure a clear audit trail is maintained. Retention times for essential documents are reviewed in the EU the regulation stipulates that data has to be kept for 25 years. As more and more information has to be archived the use of off-site or commercial archives is becoming more common and the additional requirements for a third party service provider are described. The introduction of eArchiving and the associated problems with long term storage of electronic data are discussed along with the various methods that may be used. The FDA issued guidance for electronic data and compliance with this guidance, CFR21 part 11, is vital. CFR 21 part 11 is widely followed within Europe and the standard is frequently referred to by the regulatory inspectors.

Access to the complete content on Oxford Medicine Online requires a subscription or purchase. Public users are able to search the site and view the abstracts for each book and chapter without a subscription.

Please subscribe or login to access full text content.

If you have purchased a print title that contains an access token, please see the token for information about how to register your code.

For questions on access or troubleshooting, please check our FAQs, and if you can't find the answer there, please contact us.