Frequently Asked Questions

Are there penalties if I'm supposed to register or report results, but I don't?

Apr 14, 2020, 14:16 PM
Question : Are there penalties if I'm supposed to register or report results, but I don't?
  • Yes, Section 801 of FDAAA amended the FD&C Act authorizes civil monetary penalties against responsible parties who fail to comply with registration and/or results submission requirements.
  • In relation to federally funded studies, section 402(j)(5)(A) of the PHS Act provides for the withholding of remaining or future grant funds from a grantee for failure to submit clinical trial registration and results information.
  • ICMJE policy requires, and recommends that all medical journal editors require, registration of clinical trials prior to the start of enrollment as a condition of consideration for publication. Additionally, ICMJE expects authors to ensure that they have met the requirements of their funding and regulatory agencies regarding posting of results to ClinicalTrials.gov.
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