| Do I need CHR approval for these listings? 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." CHR review and approval is still
required for flyers, posters, radio and TV advertisements,
and letters sent to potential subjects. |