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FDAAA 801, The Final Rule (42 CFR Part 11), and ClinicalTrials.Gov Registration
drug, biological, or device product is tested in conjunction with, or compared to, one or more other drug, biological, or device products (including a placebo or sham), then the products would be considered "under investigation" for purposes of this ACT condition.
G. Which trials need to be registered and results reported in ClincalTrials.gov?
Registration
PI is the IND/IDE Holder FDA Applicable Trials Funding source -NIH Required by Funding Agency Required by CMS
Required by Journal Publisher
Results Reporting
PI is the IND/IDE Holder FDA Applicable Trials Funding source -NIH Required by Funding Agency Required by CMS
Required by Journal Publisher
Multi-site trials are required to be registered only once, not by individual sites. Generally, industry sponsored trials do not need to be registered by local sites. They will be registered by the industry sponsor.
Key Clinical trial requirements
