Making your study available to on-line public searches is optional. Currently the Cancer Center, the Dept. of Medicine, the Positive Health Program and others all maintain separate web sites which list open studies. The Office of Research is making this web site available in the hope that a single web site will be useful for patients and other volunteers interested in participating in research.

Only if the information is to be posted on another website which does not have a published policy consistent with FDA Guidance below. In that case please also identify the web site.

The CHR is required to review and approve advertisements for research. However the FDA has published guidance that "IRB review and approval of listings of clinical trials on the internet would provide no additional safeguard and is not required when the system format limits the information provided to basic trial information, such as: the title; purpose of the study; protocol summary; basic eligibility criteria; study site location(s); and how to contact the site for further information." A CHR staff member will review the content of the information to be posted to make sure it meets the above criteria but a formal approval letter is not necessary and will not be issued. CHR review and approval is still required for flyers, posters, radio and TV advertisements, and letters sent to potential subjects.

The Principal Investigator, the Co-Principal Investigator and the Contact Person listed on the approved CHR application are given permission to submit this information through Research Online.

As soon as sufficient information is in the database the public search site will go live, hopefully by the end of October.