TO:  Research Advisory Council

FROM: Lisa Pitler, Assistant Vice Chancellor for Research

RE: New rules pertaining to Clinicaltrials.gov

The Final Rule for Clinical Trials Registration and Results Submission (42 CFR Part 11) and the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information become effective for clinical trials initiated on or after January 18, 2017.  Additional information is available at the following websites: 

https://prsinfo.clinicaltrials.gov,

https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trialsregistration-and-results-information-submission

https://clinicaltrials.gov/ct2/manage-recs/resources#FDAAA2007

https://prsinfo.clinicaltrials.gov,

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-149.html

Both rules have significant implications, including lack of funding, potential civil or criminal actions, and civil monetary penalty actions as outlined in 42 CFR 11.66. 

Educational materials and webinars are available on the OVCR Clinical Trials Office website at http://research.uic.edu/ct under the clinicaltrials.gov tab.  Please note that you will need to click on the “Log in for Secure Content” to gain access to the materials and webinars.

For additional information, please contact, Lisa Pitler, JD, MS, RN, Assistant Vice Chancellor, Office of the Vice Chancellor for Research at 312-413-1632; or lpitler@uic.edu.

Have a Wonderful Holiday Season and a Happy, Healthy New Year.