Workshop: New regulations and policies for Clinicaltrials.gov
Newly expanded requirements for submitting clinical trial registration and results to ClinicalTrials.gov are the result of national efforts to improve the quality and transparency of clinical trial research. The new federal regulations and NIH policies go into effect on Jan. 18.
A notable change is that protocols and statistical analysis plans will be required to be uploaded to face the public when reporting results. Consequences of noncompliance include steep fines, civil penalties and criminal liability.
To learn more about how these upcoming changes will affect your trials, please attend a training session where U-M Medical School Office of Regulatory Affairs presenters will highlight key regulatory and policy changes, reveal new and newly required fields, and perform a live demonstration of the new ClinicalTrials.gov system.
Three trainings will be offered in January. Click here to register for a session. Monthly hands-on registration and results reporting workshops for ClinicalTrials.gov users are also available by visiting the registration website.