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Subject:
Need consent form used in A to Z study of Zocor ,a Statin
Category: Health > Medicine Asked by: jpalmerlaw-ga List Price: $200.00 |
Posted:
02 Jan 2006 14:36 PST
Expires: 01 Feb 2006 14:36 PST Question ID: 428144 |
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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There is no answer at this time. |
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Subject:
Re: Need consent form used in A to Z study of Zocor ,a Statin
From: njbagel-ga on 02 Jan 2006 20:02 PST |
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 |
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