Consistent with the default adverse events reporting provisions of section 801(a) of the FDA Amendments Act of 2007 (FDAAA) [as it amends 42 U.S.C. 28 2(j)(3)(I)(ii)-(iii)], starting on September 27, 2009, Responsible Parties are expected to submit summary adverse event information when providing study results to ClinicalTrials.gov. Responsible Parties who submit results information-or update a record that contains results information-on or after September 27, 2009 must submit adverse event information in order for their submission to be accepted by the system.

The adverse event module consists of two tables for adverse events: one table for serious adverse events, and one table for other (not including serious) adverse events that exceed a frequency threshold of 5 percent within any arm of the clinical trial. Responsible Parties may voluntarily use a reporting threshold that is lower than 5 percent, if they so desire, but they will no longer be permitted to use a reporting threshold that is higher than 5 percent. (Note that data submitted to the adverse event module prior to September 27, 2009 will only need to be updated if the data entered correspond to a threshold greater than five percent.)

Several optional data elements were added to the system in early September 2009 and include the following:

• Time Frame for Adverse Event Reporting
• Additional Description of adverse event data collection, overall and/or for any individual Adverse Event Term
• Table Default for entering Source Vocabulary and/or Assessment Type (to facilitate data entry)
• Total Number of Participants at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events (per arm/group; required if Number of Participants at Risk for each term is not entered)

Additional Information

Last updated: September 28, 2009