FDAAA Registration Requirements

FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 (FDAAA)

I. REGISTRATION
FDAAA is a US law that requires registration of “Applicable Clinical Trials” on ClinicalTrials.gov.
What is an Applicable Clinical Trial?
Applicable Clinical Trials are defined as:

  • Interventional trials (drugs, biologics, devices)
  • Phase 2 – 4 (not phase 1 drug; not small feasibility device)
  • US FDA jurisdiction (e.g. IND/IDE or US site)
  • Studies initiated on or after September 27, 2007 or ongoing as of December 26, 2007

For additional information see Elaboration of Definitions of Responsible Party and Applicable Clinical Trial.

When do I register?
Registration must be completed:

  • Within 21 days of enrollment of 1st subject, AND
  • Updated at least every 12 months

II. RESULTS REPORTING
FDAAA also requires reporting of aggregate results and adverse event information.
Am I required to submit results for my study?
Reporting of results and adverse event information is required for:

  • Interventional trials (drugs, biologics, devices)
  • Phase 2 – 4 (not phase 1 drug; not small feasibility device)
  • US FDA jurisdiction (e.g. IND/IDE or US site)
  • Studies initiated on or after September 27, 2007 or ongoing as of December 26, 2007
  • Study product approved (for any use) by FDA

When do I submit results?
Results reporting must be completed:

  • Within 12 months of primary endpoint completion date, which is defined as the date at which the last endpoint of the primary endpoint was collected (not last subject last visit)
  • Delays are possible by request to CT.gov if you are::
    • The manufacturer of the investigational product and seeking initial approval
    • The manufacturer of the investigational product and seeking approval for a new use
    • You are requesting an extension for “good cause”

Note: Clinical investigations of an FDA approved product that are not intended to be submitted to the FDA in support of a change in labeling, are not eligible for a delay in results reporting. This includes investigations that are conducted under IND/IDE.

III. RESPONSIBLE PARTY
Who is the Responsible Party?
The Responsible Party (RP) is required for two basic elements of compliance:

  • The registration of the “applicable clinical trials”
  • The reporting of summary results information, including adverse events

The FDA Amendments Act of 2007 (FDAAA) defines the Responsible Party as:

  • The IND/IDE holder
  • If no IND/IDE:
    • The industry, cooperative group, consortium or other external sponsor that initiated the study
    • If initiated by a Principal Investigator
      • The grantee institution (i.e. RU)
      • If no external funding, the PI

For additional information see Elaboration of Definitions of Responsible Party and Applicable Clinical Trial.

Can A Grantee Institution Delegate The Responsibilities Of The Responsible Party?
Yes, to an individual who:

  • Is responsible for conducting the study
  • Has access to and control over the data
  • Has the right to publish the trial results, AND
  • Has the ability to meet the requirements