2 ICORG study sites pass Irish Medicines Board GCP Audit

Two ICORG sites past Irish Medicines Board audit: There is a new initiative by the Irish Medicines Board to audit a percentage of the most active Irish investigators each year. This started in 1999. Two ICORG study sites were chosen for review in the first year. The audit possibility has always been available to the Irish Medicines Board in the past but for a variety of reasons has not been enforced prior to 1999. There is a growing local necessity for a more active regulatory role in light of the developments at a European level. The EU intends to implement a community wide single regulatory process covering a range of regulatory responsibilities spanning from the initial clinical research stage through to the licensing of the final pharmaceutical product. In view of this the Irish medicines board must ensure that the research being carried out in this country is up to the European GCP standard (GCP is good clinical practice, a directive for standards in clinical research developed by the EU commission starting in 1987 amended many times up to 1997 at which point it was combined with similar guidelines in Asia and was finalised as the “ICH – GCP guidelines”). (Link to be EMEA ICH GCP guidelines Web address) I'm delighted to be able to report that these audits went very well, the protocol adherence, clinical methods, data collection and, regulatory and ethical compliance were all found to be “to a very high standard, and fully in compliance with GCP”. The audit preparation process and the discussions during the audit have proved to be very useful experience, ICORG can therefore add pre-Irish medicines board audit advice to the range of audit advice already available to members.