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.
No, posting of tabular results data to ClinicalTrials.gov is not considered prior publication. Here’s the ICMJE policy.
If required, results must be posted within 12 months of the Primary Completion Date, that is, within 12 months of the last study visit where you collected data for your primary outcome measure.
This 12 month deadline has nothing to do with IRB closure, publication, data analysis, etc. so be prepared to your data within 12 months of your last study visit.
Briefly, before enrollment begins. Applicable Clinical Trials are required under 42 CFR Part 11 to register within 21 days of enrolling the first subject, but NIH and ICMJE policy both require registration prior to the start of enrollment.
Reporting basic results data to ClinicalTrials.gov, if required
Responding to comments and addressing QA issues with the record identified by the ClinicalTrials.gov Protocol Registration and Results System (PRS) staff and UCD AMC ClinicalTrials.gov administrators
Incoming or departing faculty must transfer their ClinicalTrials.gov records with them. Contact email@example.com and we’ll help you transfer your records. (Once Research Transfer resources are ready, lets link to that page)
Yes, if your study is an Applicable Clinical Trial (ACT), or probable ACT.