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.
Related campus :
Related target Audience :
Tags :
Categories :