Jan Robinson MICR CSci
Keywords
Audit, Good Clinical Practice (GCP), Quality assurance, Survey
Whatever your current role or previous experience in the pharmaceutical industry, quality activities will have impacted your working life. In clinical operations, a plethora of audits will have featured in your project plans and no doubt you will have been at the receiving end of a variety of quality initiatives. If you work in a quality role, you may well have been audited either by your own QA department, or by a client, or both.
We all know the requirement for clinical trial audit as expressed in ICH GCP Section 1.6: “
Systematic and independent examination of trial related activities and documents to determine whether the evaluated trial activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP) and the applicable regulatory requirements”.
No-one questions the need for quality assurance of clinical trial activities but as someone at the receiving end have you ever been asked your opinion of the process? To what extent do you perceive audit as just a painful cross to bear and a necessary, negative experience? In your view, is audit a positive force for improvement? To what extent do study audits really benefit the study in question and the programmes in general? Are they the best means of advancing best practice or should we be taking a different approach?
Somewhat foolishly, I mentioned to my quality colleagues that l thought that implementation of the Clinical Trial Directive (2001/20/EC) had substantially increased the audit burden across the industry and academia and that the outcome was not all positive. This resulted in a request to represent the view of clinical operations at the BARQA annual conference this October which has as the theme “Quality Assurance: Friend or Foe?”
Being somewhat circumspect about my personal bias, I searched for articles and surveys written from a clinical perspective without success. How much more powerful then to harness the members of ICR and BARQA currently working at the coalface of clinical operations and quality assurance in order to provide a broader and more robust perspective?
So, here is your chance to provide feedback coupled with the opportunity to be entered for a prize draw to win six bottles of champagne. The survey is not too challenging and should take about 10-15 minutes to complete. Overall results will be presented at the BARQA conference and published in full, in future issues of CRFocus and Quasar; individual responses will not be made public.
Six whole bottles of champagne… that may soften the blow of the next audit! To complete the survey and have a chance to win, just go to
www.zoomerang.com/Survey/?p=WEB229CUTX55QE.
Jan Robinson MICR CSci is former Chair and a key member of the ICR Project Management Special Interest Group.
