Show Summary Details
Page of

Audits and inspections 

Audits and inspections
Chapter:
Audits and inspections
DOI:
10.1093/med/9780199608478.003.0024
Page of

PRINTED FROM OXFORD MEDICINE ONLINE (www.oxfordmedicine.com). © Oxford University Press, 2020. 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: 22 September 2020

Audits and inspections are a vital and well recognised part of the clinical trial process. The requirement for quality data is recognised by everyone who works in clinical research. The ability to maintain accuracy and quality throughout a clinical trial is a dynamic process which involves both ongoing quality control (QC) steps and systematic and independent quality assurance (QA). This chapter starts by outlining the comparison between QC and QA and how these important processes form part of a Quality Management System (QMS) for an organisation. Additionally, we cannot begin to start discussing aspects of quality in clinical research without thinking about Good Clinical Practice (GCP) and this is frequently referenced throughout the chapter. Establishing a QA Unit, especially in the healthcare environment can be daunting. There always seems to be so many priorities and there are often pressures from within the organisation or from other teams for your help and support. It is important to allocate resources carefully to ensure the QA Unit is effective. By having an effective Quality Management System and a QA programme of effectual audits means that a range of possible risks may be prevented. Study-specific audits looking particularly at site audits are discussed as well as a systems based approach which is more common in larger QA Units. The audit process is reviewed in detail for both internal and external audits. Finally, inspection preparation, the inspection process and a detailed comparison of EMA, FDA and MHRA regulations used by inspectors is presented.

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.