October 31, 2007, Introduced by Reps. Espinoza, Brown, Byrum, Simpson, McDowell, Bieda, Donigan, Vagnozzi, Valentine, Corriveau, Cheeks, Polidori, Leland, Hopgood, Dean, Miller, Alma Smith, Ebli, Lemmons, Wojno, Kathleen Law, Constan, Jackson, Accavitti and Hammel and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
(MCL 333.1101 to 333.25211) by adding part 96A.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
PART 96A. CLINICAL TRIALS – HUMAN SUBJECT RESEARCH
Sec. 9655. The department shall establish a form for the
reporting of clinical trials and make the form available on its
website. The form shall include the following information
concerning any clinical trial that a manufacturer or other person
has conducted or sponsored or is in the process of conducting or
sponsoring:
(a) The name of the person that conducted or is conducting the
clinical trial.
(b) A summary of the purpose of the clinical trial.
(c) The dates during which the trial has taken or will take
place.
(d) Information concerning the results of the clinical trial
including potential or actual adverse effects of the drug or
biological product.
(e) Any other information determined by the department to be
relevant.
Enacting section 1. This amendatory act does not take effect
unless all of the following bills of the 94th Legislature are
enacted into law:
(a) Senate Bill No.____ or House Bill No. 5395(request no.
02308'07).
(b) Senate Bill No.____ or House Bill No. 5390(request no.
02309'07).
(c) Senate Bill No.____ or House Bill No. 5393(request no.
02312'07).
(d) Senate Bill No.____ or House Bill No. 5391(request no.
02313'07).
(e) Senate Bill No.____ or House Bill No. 5394(request no.
02314'07).