42 C.F.R. § 11.8
In what format must clinical trial information be submitted?
Information submitted under this part must be submitted electronically to ClinicalTrials.gov, in the format specified at https://clinicaltrials.gov or successor site.
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Information submitted under this part must be submitted electronically to ClinicalTrials.gov, in the format specified at https://clinicaltrials.gov or successor site.