I need a copy of the consent form used in the  " A to Z trial "
involving the drugs Aggrastat and Zocor (a Merck product) , most
particularly that used for the Z phase
(zocor aka simvastatin ).Research projects require Informed consent 
by the use of informed consent forms to test drugs on human subjects.
This study was published in the AMA journal  9/15/04 JAMA 292-11 page
1307 deLemos et.al, the study was initially described in an article by
 Blazing et.al. Am Heart J 2001;142:211-217 . I need a copy of the
form itself among the multicenters were U of Texas Southwestern med
Ctr in Dallas , Duke , Brigham and Womens in Boston .

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Request for Question Clarification by welte-ga on 16 Jan 2006 13:56 PST

Is there a particular institution from which you are seeking the
consent form for this study?

      -welte-ga

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Clarification of Question by jpalmerlaw-ga on 16 Jan 2006 15:47 PST

I would prefer the one used at Southwestern Medical Center in Texas in
connection with the A to Z study, however , any form used for this
study at any institution that participated in the study will satisfy
my request .

The "A to Z Trial" is a global study that initially intended to
include 381 medical centers in 38 countries.  As you mention in your
question, informed consent (IC) is required in most, if not all,
countries in which clinical research trials are preformed.  Although
the research sponsor (Merck in this case) will often provide a
recommended, or template, Informed Consent (IC), it is up to the
individual research site to finalize an IC for their particular
patient population.  As such, there probably exist nearly 380
different versions of informed consent (one for each study site) for
this very one study.  It should be noted that each site usually has
its own Institutional Review Board (IRB) which provides final approval
for the informed consent document that will be utilized at its
particular site.

Perhaps you can clarify the particular site for which you are
interested in viewing the informed consent.  It may be possible to
contact the study coordinator or principal investigator at that site
and have them fax you a copy.

njbagel