Table 3Registration and reporting requirements of the U.S. Food and Drug Administration Amendments Act, Section 801a (reprinted with permission from Wood 200942)

Type of RequirementType of TrialDeadline for ReportingType of DataEffective Date
RegistrationApplicable clinical trials of drugs or biologics and devices regulated by the FDAbNo later than 21 days after enrollment of first participant
-

Summary protocol; population, study design, outcome measures

-

Recruitment information

-

Location and contact information

Dec. 26, 2007
Basic results reportingApplicable clinical trials of approved drugs and biologics and cleared or approved devices regulated by the FDAbNo later than 1 year after completion date; delayed submission is permitted in some casesb
-

Demographic and baseline characteristics of participant sample

-

Participant flow

-

Primary and secondary outcomes

-

Certain agreements regarding dissemination of results information

Sept. 27, 2008
Adverse events reportingApplicable clinical trials of approved drugs and biologics and cleared or approved devices regulated by the FDAbNo later than 1 year after completion date; delayed submission is permitted in some casesb
-

Serious events

-

Frequent events

Sept. 27, 2009
Expanded results reportingExamples include applicable clinical trials of unapproved drugs or biologics regulated by the FDAbExamples include extension of submission date, up to 18 months after completion date, and reconsideration of timing and requirements for submitting updatescExamples include technical or lay summaries and complete protocol or other information necessary to evaluate resultsSept. 27, 2010

Note: FDA = U.S. Food and Drug Administration.

a

Information on trial registration, basic results reporting, and adverse events e-reporting is available at http://prsinfo​.clinicaltrials​.gov/definitions.html and at http://prsinfo​.clinicaltrials​.gov/fdaaa.html. The requirements for expanded results have not yet been defined.

b

According to the FDA Amendments Act, an “applicable clinical trial” is generally one that has at least one trial site in the United States. Section 801 excludes phase 1 drug trials and “early feasibility device trials.” All applicable clinical trials of devices must be submitted, but only trials of devices previously cleared or approved are posted. Note that the ICMJE and the WHO require registration of all clinical trials for drugs and devices, regardless of phase.

c

According to the FDA Amendments Act, “completion date” refers to “the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated.”

From: Finding Grey Literature Evidence and Assessing for Outcome and Analysis Reporting Biases When Comparing Medical Interventions: AHRQ and the Effective Health Care Program

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