Editing, updating and reporting results for applicable UCSF clinical trials
Summarizing trial results in the standardized format
Training for results reporting
Did you know?
Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires responsible parties to submit study results of clinical trials to ClinicalTrials.gov.
FDAAA 801 requires all applicable clinical trials to (a) be registered within 21 days of enrolling the first participant and (b) report results within 12 months of last participant visit into the ClinicalTrials.gov database system. Penalties for noncompliance may include withholding of NIH grant funding and civil monetary penalties of up to $10,000 a day.