|
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 |
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