January 18, 2017, is the date the final rule for ClinicalTrials.gov and the new National Institutes of Health (NIH) policy regarding clinical trials registration are slated to take effect.
The new ClinicalTrials.gov rule will make some previously optional elements required and will change some options available to choose from in the various drop-down boxes. Two significant changes under the new rule are changes in the results reporting section and a requirement for the protocol and statistical analysis plan. The final rule will continue to exclude Phase 1 and small device feasibility trials. More details about the changes are available here.
The revised NIH policy will require all studies, including behavioral research and regardless of phase, to register and to submit results if they receive full or partial monetary funding. This funding criterion excludes equipment and institutional support.
Full compliance with the revised rule and policy will be expected by April 18th, 2017. Possible consequences for failing to comply can include refusal to publish, civil penalties of up to $10,000 per violation, and loss of NIH funding for both the investigator and the institution.
For additional help with registration and reporting, you can contact clinicaltrials.gov administrator Tracy Gatlin at 501-686-6803 or at tlgatlin@uams.edu.
See the table below for a summary of registration and reporting requirements that may affect your research.
- International Committee of Medical Journal Editors requirements.
- This is the new clinicaltrials.gov rule.
Our thanks to Ms. Gatlin for putting this blog item together for us!