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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 - 2011

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TimeTargetNumber of Inquiries
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/A260
Feb 2011N/A235
Mar 2011N/A284
Apr 2011N/A227
May 2011N/A238
Jun 2011N/A244
Jul 2011N/A217
Aug 2011N/A232
Sep 2011N/A204

FY 2011 Total: 2,141

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 - 2011
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TimeTargetNumber of Inquiries
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/A223
Feb 2011N/A205
Mar 2011N/A256
Apr 2011N/A207
May 2011N/A221
Jun 2011N/A213
Jul 2011N/A195
Aug 2011N/A202
Sep 2011N/A177

FY 2011 Total: 1,899

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 - 2011
Skip graphic and jump to text data.

TimeTargetNumber of Inquiries
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/A37
Feb 2011N/A30
Mar 2011N/A28
Apr 2011N/A20
May 2011N/A17
Jun 2011N/A31
Jul 2011N/A22
Aug 2011N/A30
Sep 2011N/A27

FY 2011 Total: 242

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.