Grants and Funding
NIH Implementation of FDAAA

FDAAA Requirements for NIH Grantees At-A-Glance

The following NIH "FDAAA Requirements for NIH Grantees At-A-Glance" chart provides basic information about the key moments when FDAAA requires certain activities be undertaken. The chart also identifies whether the action is required of all NIH grantees regardless of whether or not they are the responsible party, or required only of the responsible party. Note, actions required only of the responsible party may not be undertaken by entities or individuals who are not the responsible party. For further information, please see FAQ for NIH Grantees:

FDAAA Requirements for NIH Grantees At-A-Glance

 

Trigger event

Action

Required of all NIH grantees regardless of whether or not they are the responsible party

Required of the responsible party only

A

Prior to applying for the NIH grant or cooperative agreement

Determine if the proposed or on-going trial is an applicable clinical trial that is required to register in ClinicalTrials.gov under FDAAA. (See step 1)

Yes

No

B

NIH grant application submission

If the trial is an applicable clinical trial that is required to be registered in ClinicalTrials.gov under FDAAA, certify compliance with FDAAA in the competing application. (See step 2)

Yes

No

C

Prior to registration in ClinicalTrials.gov

Appropriate institutional officials should ascertain which entity or individual is the responsible party. (See step 3 and 4)

Yes

No

D

Enrollment of first subject

Register trial no more than 21 days after the enrollment of the first subject. (See step 5)

No

Yes

E

NIH progress report submission

Certify compliance with FDAAA in non-competing continuation progress reports. (See step 2)

Yes

No

F

Enrollment status changes

Update the recruitment status not later than 30 days after the recruitment status of the trial has changed. (See step 6)

No

Yes

G

A year has passed since the record was last updated.

Update the record not less than once every 12 months, unless there were not changes to the clinical trial information during the preceding 12-month period. (See step 6)

No

Yes

H

Final subject is examined or receives an intervention for the purpose of final collection of data for the primary outcome. (called the "primary completion date" in ClinicalTrials.gov)

Update the primary completion date entry for the applicable clinical trial not later than 30 days after the primary completion date. (See step 6)

No

Yes

I

Not later than 1 year after the final data collection for the prespecified primary outcome measure (called “primary completion date” in ClinicalTrials.gov)

Submit summary results (including adverse event information) if required. (See step 7)

No

Yes



The NIH encourages registration and results reporting for all NIH-supported clinical trials, regardless of whether or not they are subject to FDAAA.

This page last updated on May 26, 2011
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