Zenosis are pleased to announce the release of a new module entitled 'Preparing for a GCP audit or inspection'.

Clinical trial sites of Sponsors and Investigators are subject to rigorous inspection by regulatory authorities to ensure compliance with Good Clinical Practice (GCP). Auditing assures the authority (and the Sponsor) that good standards are being maintained and that the sites are fit to undertake clinical studies.

Preparing adequately to cooperate with auditors/inspectors requires an understanding of their agendas and goals. Understanding why specific documentation, processes and functions are checked and what the auditor/inspector is looking for will substantially enhance internal QA procedures.

This module explores the phases preceding a GCP audit/inspection. It gives an overview of what is meant by audits/inspections and demystifies the whole process by breaking it down to its original components. The differences between audits and inspections are explained in so far as they affect the stages leading up to the procedures themselves. European and US aspects are examined in the context of audit/inspection of the Sponsor and of the Investigator's site.