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.

• FY 2011
• FY 2012
• All

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

Time	Target	Number of Inquiries
Oct 2011	N/A	179
Nov 2011	N/A	148
Dec 2011	N/A	177
Jan 2012	N/A	161
Feb 2012	N/A	205
Mar 2012	N/A	196
Apr 2012	N/A	128
May 2012	N/A	133

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

Time	Target	Number of Inquiries
Oct 2011	N/A	15
Nov 2011	N/A	27
Dec 2011	N/A	23
Jan 2012	N/A	40
Feb 2012	N/A	17
Mar 2012	N/A	14
Apr 2012	N/A	20
May 2012	N/A	19

FY 2012 Oct-May Total: 175

Footnotes

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