GCP: A Question & Answer Reference Guide Figure 2: INSPECTIONS OUTSIDE EU (January 2013-December 2013-52 inspections) General Trial Management (Sponsor) Investigational Site Deficienty Category Name Investigational Medicinal Products (IMP) Subject protection IEC/IRB Informed Consent (IC) Laboratory/Technical Facilities Computer System Regulatory Issues Others 0 30 60 90 # Deficiencies 120 150 180 Q4. The FDA and European Medicines Agency (EMA) have published the report from the pilot GCP cooperation program. What can we expect for the next steps and goals for 2014? Is further cooperation planned/anticipated? A. In light of the successful implementation of the initiative between FDA and EMA since 2009, the EMA, the FDA and the regulatory authorities in some EU Member States agreed to launch a joint initiative to collaborate on the sharing of information and conduct of inspections of bioequivalence studies submitted in support of marketingauthorisation applications for generic medicines. The objectives and the list of EU Member States involved are described in the Terms of Engagement (http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/12/ WC500158548.pdf) for this initiative. The initiative began with an 18-month pilot phase that will run between January 2014 and June 2015. A report on its outcome will be made available after the pilot phase. Q5. In the past you have noted the problem of sponsors not securing compliance at sites after discovering noncompliance? Is this getting better or is it still an issue? A. A significant part of the issues raised at investigator sites arise from issues related to the sponsor/CRO role, either prospectively through poor design and planning or as the trial proceeds through failures to review, analyse, and act upon information coming back from the sites whether in the form of monitoring reports or of data. Q6. Is there any update or new GCP/compliance perspectives we can expect focusing on issues related to computerized systems and electronic records and the use of electronic systems in clinical trials? A. In this context the following reflection paper was published in 2013, Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials (http://www.ema.europa.eu/docs/ en_GB/document_library/Scientific_guideline/2011/08/WC500110227.pdf). 572http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/12/WC500158548.pdf http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/12/WC500158548.pdf http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500110227.pdf http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500110227.pdf