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document.write('<p class="rss_item"><a class="rss_item" href="http://ehip.blogs.com/21cfrpart11/2009/10/microsoft-sharepoint-as-an-edc-or-supporting-an-edc.html" title="There has been some interest in using Sharepoint as an EDC. We have attempted doing so ourselves and found its limitations for actual data collection are significant. Put another way, the amount of effort it would take to write code......" target="_self">Microsoft sharepoint as an EDC or supporting an EDC ?</a><br />');
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document.write('<p class="rss_item"><a class="rss_item" href="http://ehip.blogs.com/21cfrpart11/2009/09/de-identification-of-clinical-trials-data.html" title="A paper by Shostak describes a set of SAS routines for coding clinical trial datasets (paper: http://www.lexjansen.com/pharmasug/2006/publichealthresearch/pr02.pdf; web archive: http://www.webcitation.org/5jxKAuL10). As our recent overview of de-identific..." target="_self">De-identification of clinical trials data</a><br />');
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document.write('<p class="rss_item"><a class="rss_item" href="http://ehip.blogs.com/21cfrpart11/2009/08/21-cfr-part-11-book.html" title="I just wanted to bring to people\'s attention this book which discusses 21 CFR Part 11 and computer systems validation. Although a bit dated, much of the material is still relevant and a good one to have on your part......" target="_self">21 CFR Part 11 book</a><br />');
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document.write('<p class="rss_item"><a class="rss_item" href="http://ehip.blogs.com/21cfrpart11/2009/08/how-many-clinical-trials-are-using-edc.html" title="We recently published a study whose purpose was to estimate the number of Canadian clinical trials (i.e., those with sites in Canada) that were using EDC. We focused on trials that were running during the 2006 and 2007 calendar years......." target="_self">How many clinical trials are using EDC ?</a><br />');
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document.write('<p class="rss_item"><a class="rss_item" href="http://ehip.blogs.com/21cfrpart11/2009/04/open-source-edc.html" title="I have received a number of questions about the existence of an open source EDC system that can be use din the context of academic research. The best known one is OpenClinica and the people I know who have used......" target="_self">Open Source EDC</a><br />');
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document.write('<p class="rss_item"><a class="rss_item" href="http://ehip.blogs.com/21cfrpart11/2008/07/de-identifying.html" title="In the last posting I spoke about masking as a technology to help protect the privacy of patients when using real clinical trial data for testing protocol amendments. Masking is not enough, however. Let me illustrate through an example. Let\'s......" target="_self">De-identifying protocol amendment test data for e-clinical trials</a><br />');
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document.write('<p class="rss_item"><a class="rss_item" href="http://ehip.blogs.com/21cfrpart11/2008/07/protecting-test.html" title="When testing an electronic clinical trial system after a protocol amendment, you will probably need to mask real data so that you can use it for testing. Masking is the first step in protecting the privacy of the patient data......." target="_self">Protecting test data privacy when testing protocol amendments</a><br />');
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document.write('<p class="rss_item"><a class="rss_item" href="http://ehip.blogs.com/21cfrpart11/2008/07/getting-good-da.html" title="After making changes to an e-clinical trial, say due to a protocol amendment, it is necessary to re-validate the system. This necessitates running tests on the data collection forms, any logic embedded within them, real-time or batch rules for the......" target="_self">Getting good data for testing protocol amendments in your e-clinical trial</a><br />');
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document.write('<p class="rss_item"><a class="rss_item" href="http://ehip.blogs.com/21cfrpart11/2008/07/archiving-data.html" title="Most national regulations require that the data from a clinical trial be archived and available for a number of years after the trial\'s completion. That number of years varies by country. This means that the clinical trial needs to have......" target="_self">Archiving data from e-clinical trials</a><br />');
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document.write('<p class="rss_item"><a class="rss_item" href="http://ehip.blogs.com/21cfrpart11/2008/07/whats-in-an-aud.html" title="Maintaining an audit trail is a 21 CFR Part 11 compliance requirement. But what makes a good audit trail that is effective and meets the regulation\'s intentions ? I have seen audit trails that capture every single transaction that runs......" target="_self">What\'s in an audit trail ?</a><br />');
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