Effective January 18, 2017 more studies require registration in clinicaltrials.gov and the reporting requirements have increased. Investigators have 90 days to come into compliance. The NIH is mandating that all clinical trials with any NIH funding register. Summary results information must be submitted for more trials, including FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA. Reporting changes include uploading the full IRB protocol and providing more information regarding adverse events. Clinicaltrials.gov reporting takes a substantial time investment, you should consider including effort in your proposal budget. Additionally, many journals require registration before the first research participant is enrolled. Enforcement for noncompliance includes the termination or withholding of grant funding.