MainThe Office of Good Clinical Practice (OGCP) is the focal point within FDA for good clinical practice and human subject protection issues arising in the conduct of FDA-regulated clinical research. Outreach is an essential part of OGCP’s mission. OGCP strives to share with the public and the clinical research community important information about running clinical trials and compliance with FDA’s regulations. Each month, OGCP receives through its Good Clinical Practice Questions mailbox (<a href=gcp.questions@fda.hhs.gov target=”_blank”>gcp.questions@fda.hhs.gov</a>), or directly to OGCP staff members, an average of 200 inquiries from institutional review boards, clinical investigators, sponsors, contract research organizations, monitors, individuals interested in participating in clinical trials, and others. Those inquiries often involve critical questions about key areas of clinical research. It is crucial that those inquiries receive OGCP’s prompt attention especially when they involve human subject protection or data integrity issues. OGCP posts its responses to redacted inquiries about good clinical practice on the <a href=http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/RepliestoInquiriestoFDAonGoodClinicalPractice/default.htm target=”_blank”>FDA website</a>. (1) This measure will no longer be tracked after May 2012.Number of Inquiriescolumn

FY 2011 Total: 2,141

Oct 2010N/ANov 2010N/ADec 2010N/AJan 2011260Feb 2011235Mar 2011284Apr 2011227May 2011238Jun 2011244Jul 2011217Aug 2011232Sep 2011204

FY 2012 Oct-May Total: 1,502

Oct 2011194Nov 2011175Dec 2011200Jan 2012201Feb 2012222Mar 2012210Apr 2012148May 2012152SubTotal number of inquiries received by OGCP within the month (1)(1) This measure will no longer be tracked after May 2012.Number of Inquiriescolumn

FY 2011 Total: 1,899

Oct 2010N/ANov 2010N/ADec 2010N/AJan 2011223Feb 2011205Mar 2011256Apr 2011207May 2011221Jun 2011213Jul 2011195Aug 2011202Sep 2011177

FY 2012 Oct-May Total: 1,148

Oct 2011179Nov 2011148Dec 2011177Jan 2012161Feb 2012205Mar 2012196Apr 2012128May 2012133SubTotal number of inquiries received by OGCP within the month (1)(1) This measure will no longer be tracked after May 2012.Number of Inquiriescolumn

FY 2011 Total: 242

Oct 2010N/ANov 2010N/ADec 2010N/AJan 201137Feb 201130Mar 201128Apr 201120May 201117Jun 201131Jul 201122Aug 201130Sep 201127

FY 2012 Oct-May Total: 175

Oct 201115Nov 201127Dec 201123Jan 201240Feb 201217Mar 201214Apr 201220May 201219http://www.fda.gov/AboutFDA/Transparency/track/ucm206293.htmFDA-TRACK Office of Special Medical Programs Dashboard ਍††਍਍਍਍਍਍਍