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U.S. Department of Health and Human Services

About FDA

Total number of inquiries received by OGCP within the month (1)

Dictionary: The 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 (gcp.questions@fda.hhs.gov), 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 FDA website.

Fiscal Year - 2012

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TimeTargetNumber of Inquiries
Oct 2011N/A194
Nov 2011N/A175
Dec 2011N/A200
Jan 2012N/A201
Feb 2012N/A222
Mar 2012N/A210
Apr 2012N/A148
May 2012N/A152

FY 2012 Oct-May Total: 1,502

Footnotes

  • (1) This measure will no longer be tracked after May 2012.

Total number of email inquiries received in the OGCP inbox within the month (1)

Fiscal Year - 2012
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TimeTargetNumber of Inquiries
Oct 2011N/A179
Nov 2011N/A148
Dec 2011N/A177
Jan 2012N/A161
Feb 2012N/A205
Mar 2012N/A196
Apr 2012N/A128
May 2012N/A133

FY 2012 Oct-May Total: 1,148

Footnotes

  • (1) This measure will no longer be tracked after May 2012.

Total number of email and telephone inquiries received by staff members within the month (1)

Fiscal Year - 2012
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TimeTargetNumber of Inquiries
Oct 2011N/A15
Nov 2011N/A27
Dec 2011N/A23
Jan 2012N/A40
Feb 2012N/A17
Mar 2012N/A14
Apr 2012N/A20
May 2012N/A19

FY 2012 Oct-May Total: 175

Footnotes

  • (1) This measure will no longer be tracked after May 2012.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.