Registration of applicable clinical trials is a requirement - per the FDA Amendments Act FDAAA, 42 U.S.C. 282(j)(1)(A), section 402(j)(1)(A) of the PHS Act.
Register and update your protocol on ClinicalTrials.gov Protocol Registration System.
Log onto Clinicaltrials.gov Protocol Registration System at least every 6 months to see any new required fields that need completion.
Also remember to update with:
- any changes in status (recruiting or closed to recruitment)
- change in owner (if person who registered trial leaves UK)
- study results and/or citation to publications
- any other modifications
NOTE: The UK IRB is in the process of revising the informed consent template to include the FDA required statement for registered trials to disclose trial registration to subjects. See FDA Final rule for details and timelines for compliance.
“A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
Administrator for the UK account on Clinicaltrials.gov
Laura Ashe, CCRC
Regulatory Manager
(859) 323-2782
llashe2@email.uky.edu