Clarification of Registration in According to Date of Initiation and Status as an “Ongoing” Trial

Notice Number: NOT-OD-10-007

Update: The following update relating to this announcement has been issued:

Key Dates
Release Date: October 23, 2009

Issued by
National Institutes of Health (NIH), (

On November 16, 2007, December 21, 2007, December 11, 2008, and September 4, 2009, the National Institutes of Health (NIH) issued the following notices (respectively):

The purpose of this Notice is to clarify earlier statements regarding registration in pursuant to the Food and Drug Administration Amendments Act (FDAAA) of 2007.  The criteria for determining when trials should be registered should read as follows:

When must “applicable clinical trials” be registered?


Specific questions about this Notice should be directed to:

Office of Extramural Programs
Office of Extramural Research
National Institutes of Health

Weekly TOC for this Announcement
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