tag:blogger.com,1999:blog-37644844265755432952024-03-12T19:00:25.660-04:00Compliance NewsCompliance News: A blog on regulatory compliance and quality assurance topics, including current Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.comBlogger21125tag:blogger.com,1999:blog-3764484426575543295.post-43707720697705986392015-10-15T17:00:00.001-04:002015-10-15T17:00:18.308-04:00ICH E6 (R2) GCP Guidelines Issued for Review<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: right; margin-left: 1em; text-align: right;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi-MjofPE8J1SXsAk9GWdnQNJ2j5t8BG0na58OVJPjYKNgPVpqwF7WEwrwpsxmdU35237U1rG8tq2ZIJTlgoes2FXCo1j0JnJVArrH87Y36Ds9BFNJIGR6ePNNG1ARzALFujBEVcw9PiU0/s1600/ICH+E6.jpg" imageanchor="1" style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi-MjofPE8J1SXsAk9GWdnQNJ2j5t8BG0na58OVJPjYKNgPVpqwF7WEwrwpsxmdU35237U1rG8tq2ZIJTlgoes2FXCo1j0JnJVArrH87Y36Ds9BFNJIGR6ePNNG1ARzALFujBEVcw9PiU0/s1600/ICH+E6.jpg" /></a></td></tr>
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<span style="font-weight: normal;"><span style="font-size: 14px;">A new draft of the <a href="http://compliancelogix.com/E6R2-GCP-June-2015.pdf" target="_blank">ICH GCP guideline</a> has been modified</span><span style="font-size: 14px;"> to address the following:</span></span></h1>
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<li style="background-image: url(http://www.gxpsrus.com/wp-content/themes/mwa/images/disc.png); background-position: 0px 6px; background-repeat: no-repeat no-repeat; border-style: none; border-width: 0px; font-size: 14px; line-height: 16px; list-style-type: none; margin: 1.2em 0px 0px; padding: 0px 0px 0px 12px;">data integrity</li>
<li style="background-image: url(http://www.gxpsrus.com/wp-content/themes/mwa/images/disc.png); background-position: 0px 6px; background-repeat: no-repeat no-repeat; border-style: none; border-width: 0px; font-size: 14px; line-height: 16px; list-style-type: none; margin: 1.2em 0px 0px; padding: 0px 0px 0px 12px;">electronic records and controls</li>
<li style="background-image: url(http://www.gxpsrus.com/wp-content/themes/mwa/images/disc.png); background-position: 0px 6px; background-repeat: no-repeat no-repeat; border-style: none; border-width: 0px; font-size: 14px; line-height: 16px; list-style-type: none; margin: 1.2em 0px 0px; padding: 0px 0px 0px 12px;">validation of computer systems used for GCP</li>
<li style="background-image: url(http://www.gxpsrus.com/wp-content/themes/mwa/images/disc.png); background-position: 0px 6px; background-repeat: no-repeat no-repeat; border-style: none; border-width: 0px; font-size: 14px; line-height: 16px; list-style-type: none; margin: 1.2em 0px 0px; padding: 0px 0px 0px 12px;">risk management approach on behalf of the sponsor and the CRO to evaluate, identify, control, mitigate, and communicate the major risks</li>
<li style="background-image: url(http://www.gxpsrus.com/wp-content/themes/mwa/images/disc.png); background-position: 0px 6px; background-repeat: no-repeat no-repeat; border-style: none; border-width: 0px; font-size: 14px; line-height: 16px; list-style-type: none; margin: 1.2em 0px 0px; padding: 0px 0px 0px 12px;">oversight responsibilities of the sponsor</li>
<li style="background-image: url(http://www.gxpsrus.com/wp-content/themes/mwa/images/disc.png); background-position: 0px 6px; background-repeat: no-repeat no-repeat; border-style: none; border-width: 0px; font-size: 14px; line-height: 16px; list-style-type: none; margin: 1.2em 0px 0px; padding: 0px 0px 0px 12px;">integrity of the data</li>
<li style="background-image: url(http://www.gxpsrus.com/wp-content/themes/mwa/images/disc.png); background-position: 0px 6px; background-repeat: no-repeat no-repeat; border-style: none; border-width: 0px; font-size: 14px; line-height: 16px; list-style-type: none; margin: 1.2em 0px 0px; padding: 0px 0px 0px 12px;">risk based monitoring</li>
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Download the new guideline <a href="http://compliancelogix.com/E6R2-GCP-June-2015.pdf" target="_blank">here</a></div>
Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com1tag:blogger.com,1999:blog-3764484426575543295.post-20422641271280097162015-08-07T16:13:00.002-04:002015-08-07T16:14:59.291-04:00FDA Guidance on Analytical Procedures and Methods Validation for Drugs and Biologics<div>
The U.S. Food and Drug Administration released a final guidance on Analytical Procedures and Methods Validation for Drugs and Biologics. The guidance document provides recommendations for submitting analytical procedures and methods validation data to support the documentation of the identify, strength, quality, purity and potency of drug substances and drug products. The scope of the guidance document applies to drug substances and drug products covered in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications.</div>
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Read the Guidance document <a href="http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm386366.pdf" target="_blank">here</a>Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com17tag:blogger.com,1999:blog-3764484426575543295.post-70964240448270148092015-05-22T13:19:00.001-04:002015-05-22T13:19:29.212-04:00How to Tip Off a GCP Auditor in 25 Words or LessGreat article by Laurie Meehan<br />
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<a href="http://mastercontrolinc.blogspot.com/2015/05/how-to-tip-off-gcp-auditor-in-25-words.html">http://mastercontrolinc.blogspot.com/2015/05/how-to-tip-off-gcp-auditor-in-25-words.html</a>Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com11tag:blogger.com,1999:blog-3764484426575543295.post-80745720610860459642015-05-18T12:13:00.002-04:002015-05-18T12:22:30.095-04:00FDA Draft Guidance for Adaptive Designs for Medical Device Clinical StudiesThe U.S. Food and Drug Administration (FDA) issued a draft guidance today for Adaptive Designs for Medical Device Clinical Studies. The document provides guidance on how to plan and implement adaptive designs for clinical studies that allow for prospectively planned modifications based on accumulating study data without undermining the integrity and validity of a trial.<br />
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Read the full draft guidance <a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM446729.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery" target="_blank">here</a>Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com5tag:blogger.com,1999:blog-3764484426575543295.post-39354881561297208652015-04-09T15:33:00.002-04:002015-04-09T15:33:25.606-04:00<div style="margin: 0in 0in 0pt;">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi03Ws0dkh-19BzhCHQeTW3W6jqeU7YgtH3Hksb5f1Ae1SGP7D0g-nZekyEc05D1tJvsGwqRU8Kd7KTzq3VCczV7ZN2UkgBUfDnnYnAGCM1NeRoDj6GTxM6C97WC8lhtcrBUzJA3_CORm8/s1600/informed+consent.jpeg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi03Ws0dkh-19BzhCHQeTW3W6jqeU7YgtH3Hksb5f1Ae1SGP7D0g-nZekyEc05D1tJvsGwqRU8Kd7KTzq3VCczV7ZN2UkgBUfDnnYnAGCM1NeRoDj6GTxM6C97WC8lhtcrBUzJA3_CORm8/s1600/informed+consent.jpeg" /></a></div>
<span style="font-family: Arial, Helvetica, sans-serif;">The U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) will present a webinar on the draft guidance for industry, <i>Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers, </i>on Monday, 20 April 2015, from 1:00 p.m. – 2:00 p.m. EDT.</span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">The guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for regulated clinical investigations. A copy of the guidance may be found at: <a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery">http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery</a></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><strong>Access the Webinar on Monday, 20 April 2015, from 1:00pm - 2:00pm using the following link</strong>: <a href="http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTUwNDA4LjQzOTE3ODMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE1MDQwOC40MzkxNzgzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MTA2MzMyJmVtYWlsaWQ9YnZlbmdyb2ZmQGNvbXBsaWFuY2Vsb2dpeC5jb20mdXNlcmlkPWJ2ZW5ncm9mZkBjb21wbGlhbmNlbG9naXguY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&102&&&https://collaboration.fda.gov/guidancewebinars/?source=govdelivery&utm_medium=email&utm_source=govdelivery">https://collaboration.fda.gov/guidancewebinars/</a></span></div>
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Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com0tag:blogger.com,1999:blog-3764484426575543295.post-28414368821797297942014-07-27T15:42:00.004-04:002014-07-27T15:45:27.889-04:00Draft FDA Guidance for Informed Consent<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhdN9RmZv8SCPrui0TsPow0yl90UpV1D5qTFqCtjlteSUgOACgK_C4O8bIkFV6UnHaji6kF5-NMs4sFgw9YQHFWXfb0Cs5a8-wBdkR_zlWboazZw2Nlz0-IncZLOGrVvV73HHx_K4wqU_k/s1600/informed+consent.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="" border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhdN9RmZv8SCPrui0TsPow0yl90UpV1D5qTFqCtjlteSUgOACgK_C4O8bIkFV6UnHaji6kF5-NMs4sFgw9YQHFWXfb0Cs5a8-wBdkR_zlWboazZw2Nlz0-IncZLOGrVvV73HHx_K4wqU_k/s1600/informed+consent.jpg" height="133" title="Draft FDA Guidance for Informed Consent" width="200" /></a><span style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em; text-align: left;"><br /></span><span style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em; text-align: left;"><br /></span></div>
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The U.S. Food and Drug Administration (FDA) published a new draft guidance for informed consent this July 2014. The guidance is intended to provide information to clinical investigators, study sponsors and institutional review boards (IRBs) about the FDA's informed consent regulations. When finalised, this guidance will supersede FDA's previous publication, "A Guide to Informed Consent" that was issued in September 1988. </div>
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<< <a href="http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM405006.pdf" target="_blank">Click here to view the full guideline</a> >></div>
Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com0tag:blogger.com,1999:blog-3764484426575543295.post-67269163164005953542014-07-24T23:26:00.001-04:002014-07-24T23:26:36.599-04:00Online Training PreviewNew video preview available now: <a href="http://animoto.com/play/w0c0Ntpj7pAANQWhjlsH1Q">Online Training Preview</a>Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com3tag:blogger.com,1999:blog-3764484426575543295.post-34334778529742983632014-05-30T13:31:00.000-04:002014-05-30T13:31:32.779-04:00New Clinical Trials Regulation EU No. 536/2014 on Clinical Trials with Medicinal Products for Human Use<div style="font-family: Helvetica; min-height: 14px;">
<span style="font-size: x-small;"><a href="http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:JOL_2014_158_R_0001&from=EN" target="_blank">Regulation (EU) No 536/2014</a> published on 16 April 2014 by the European Parliament and the Council of the European Union on clinical trials on medicinal products for human use. This regulation will repeal Directive 2001/20/EC. </span></div>
Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com2tag:blogger.com,1999:blog-3764484426575543295.post-20468862065596240342013-05-17T10:47:00.001-04:002015-05-18T12:23:11.926-04:00Dirty Medicine<div>
Original article, "Dirty Medicine: The epic inside story of long-term criminal fraud at Ranbaxy, the Indian drug company that makes Lipitor" by Katherine Eban:</div>
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<a href="http://features.blogs.fortune.cnn.com/tag/ranbaxy/">http://features.blogs.fortune.cnn.com/tag/ranbaxy/</a>Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com21tag:blogger.com,1999:blog-3764484426575543295.post-77304620325342563472013-04-18T07:14:00.001-04:002013-04-18T07:22:56.240-04:00First successful MHRA prosecution under Good Laboratory Practice Regulations<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgxLy_kMOU2KncWqSbn34d9ZMqJyP4Q6eZipCGrZjZ05wJFEF-33hC-3246ML0BppKEVfJYAXTUe9sLkDYYj2y_lP4wUv8cDnaVmXcUFXWXXyC67Lw2hbEvtFTEP2AY3aPgvirLAaWurqM/s1600/GLP_MHRA_Prosecution.jpeg" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgxLy_kMOU2KncWqSbn34d9ZMqJyP4Q6eZipCGrZjZ05wJFEF-33hC-3246ML0BppKEVfJYAXTUe9sLkDYYj2y_lP4wUv8cDnaVmXcUFXWXXyC67Lw2hbEvtFTEP2AY3aPgvirLAaWurqM/s1600/GLP_MHRA_Prosecution.jpeg" /></a></div>
The Medicines and Healthcare Products Regulatory Agency (MHRA) announced yesterday that a man was sentenced to three months in prison for altering pre-clinical trial data designed to support applications to perform clinical trials.</div>
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Steven Eaton was found guilty at Edinburgh Sheriff’s Court in March following a prosecution under the Good Laboratory Practice Regulations 1999. This is the first time the MHRA has successfully used these regulations to bring a prosecution.</div>
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The case came about when Aptuit informed the MHRA that they had identified serious irregularities in pre-clinical data generated to support human clinical trials and the registration of new medicines.</div>
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The irregularities involved changing or providing false analytical data that would be used to determine the concentration of medicine that could be given to clinical trial subjects used to assess the safety and efficacy of a new medicine.</div>
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The MHRA launched an investigation to identify the number of studies affected and the impact the data irregularities would have on the interpretation of important safety data. The investigation concluded that Mr. Eaton had selectively reported analytical data over a number of years, dating back to 2003. During this period he selectively reported data which was used to assess whether analytical methods were working properly or to assess the concentration of the drug in blood. The data manipulation ensured an experiment was deemed successful when in fact it had failed.</div>
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The actions led to the review of many hundreds of safety studies assessing the impact of the data manipulation and to ensure that the compromised data was not used in future submissions to relevant authorities without their knowledge.</div>
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As a result of Mr. Eaton’s actions the development of a number of new medicines were significantly delayed and considerable cost to the study sponsors was incurred as a result of the delay.</div>
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Following a full assessment by the MHRA’s inspection team and assessors it was concluded that the data integrity issues did not invalidate the results of the clinical trials that were affected.</div>
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Gerald Heddell, MHRA Director of Inspection, Enforcement and Standards said, “Mr. Eaton’s actions directly impacted on the validity of clinical trials and delayed a number of medicines coming to market, including one to treat depression. The sentence sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health."</div>
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[Medicines and Healthcare Products Regulatory Agency. (2013). Man jailed in pre-clinical trial data scam case (Press release]. Retrieved from http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON263951.]</div>
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Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com14tag:blogger.com,1999:blog-3764484426575543295.post-56191027903802102102013-03-19T09:17:00.000-04:002013-03-19T09:17:59.936-04:00The 7th System: Integrating Clinical Systems into a Comprehensive Quality Audit Program<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhSe4E8kyRVaigZtF8JNElOupta3KOEpuqXdTJHuLk7iJovWcephYQu4XcMGi6Oas0bR_eFA5CeAXPx5s2FkN720ySaZfLnvQT9Jf090UCtRAawEaRjnCGa97kL6_PdDSSTa8TppozI1aM/s1600/The+7th+System.png" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhSe4E8kyRVaigZtF8JNElOupta3KOEpuqXdTJHuLk7iJovWcephYQu4XcMGi6Oas0bR_eFA5CeAXPx5s2FkN720ySaZfLnvQT9Jf090UCtRAawEaRjnCGa97kL6_PdDSSTa8TppozI1aM/s1600/The+7th+System.png" /></a></div>
<span style="font-family: Arial, Helvetica, sans-serif;"><span style="background-color: white; color: #333333; line-height: 17px;">Clinical quality systems are often managed independently of manufacturing and laboratory operations. This can result in a fractured view of each compliance area (GCP, GMP and GLP) and a failure to provide adequate oversight of an organization’s overall compliance. Using FDA’s six-system inspection model as a starting point, this article will discuss how to integrate the requirements of clinical quality systems with a GMP compliant quality program to provide </span><span style="background-color: white; color: #333333; line-height: 17px;">a system for comprehensive quality oversight. (<a href="http://www.compliancelogix.com/whitepaper/2167-0870-3-126.pdf" target="_blank">View the original article</a>)</span></span><br />
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<span style="font-family: Arial, Helvetica, sans-serif;"><span style="color: #333333;">The goals of a quality audit program are: </span></span><br />
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<li><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">to provide an accurate view of compliance across the organization, including suppliers and vendors; </span></li>
<li><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">to identify and prevent or correct compliance issues; and </span></li>
<li><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">to inform management of the compliance status of the organization. </span></li>
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<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">However, differences in the implementation of GMP (Good </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">Manufacturing Practice) and GCP (Good Clinical Practice) compliance </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">programs may occur due to the different focus of each program. The </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">GMP audit program is concerned with ensuring the identity, strength, </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">safety, purity and effectiveness of the product or device, whereas the </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">GCP audit program is focused on subject rights and safety, protocol conduct </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">and data integrity.</span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><span style="color: #333333;">Communication between the manufacturing and clinical disciplines </span><span style="color: #333333;">may be obstructed in part by the use of different terminology, or </span><span style="color: #333333;">by not using terms in the same manner to appropriately compare </span></span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">audit observations. For example, use of the audit observation type </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">“<i>Validation</i>” may describe an issue related to methods, equipment, </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">packaging, or computer systems. Without an appropriate description, </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">this audit observation type is too ambiguous to be useful in assessing, </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">preventing or correcting compliance issues. “<i>Investigational Product</i>” </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">is a common audit observation type used by clinical auditors, but this </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">term is not sufficiently descriptive when relayed to manufacturing </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">personnel as it does not describe whether the issue is related to the use, </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">storage, labeling, or quality of an investigational product.</span></div>
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<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">The use of different audit observation terminology and separate </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">reporting systems may also obstruct an accurate assessment of the </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">impact of systemic compliance issues and weaker compliance signals </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">may be lost because they are maintained and reported separately. </span></div>
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<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">The accurate assessment of compliance with Standard Operating </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">Procedures (SOPs), personnel training, vendor management, and </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">complaints requires the ability to view issues across the organization, </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">and the use of separate terms and reporting procedures may make it difficult to </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">accurately quantify the total compliance risk of these activities or </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">identify cross-functional issues that could impact investigational product </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">integrity and/or subject safety. Information from inspections of raw </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">materials, production activities, packaging, labeling, warehouse and </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">distribution, and clinical use may not be communicated effectively if </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">issues are reported and communicated separately.</span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><span style="color: #333333;"><span style="line-height: 17px;">A shared quality system, using integrated audit observation </span></span></span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">categories, terminology and reporting can help to improve </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">communication across functions and better meet the objectives of the </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">quality audit program. It should be noted that integrating the GMP </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">and GCP quality audit programs does not necessitate a particular </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">organization of the Quality Unit, although it is recommended to use the same system for </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">assessing, reporting and resolving audit observations </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">across the organization.</span><br />
<span style="color: #333333;"><span style="font-family: Arial, Helvetica, sans-serif; line-height: 17px;"><br /></span></span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">The </span><a href="http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4136b1_05_pharmaceutical%20CGMP.pdf" style="font-family: Arial, Helvetica, sans-serif; line-height: 17px;" target="_blank">Six-System Inspection Model</a><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;"> defined by the U.S. Food and </span><span style="color: #333333;"><span style="font-family: Arial, Helvetica, sans-serif; line-height: 17px;">Drug Administration (FDA) provides an excellent foundation upon </span></span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">which to define the categories of a quality audit program. The model </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">defines the following six systems:</span><br />
<span style="color: #333333;"><span style="font-family: Arial, Helvetica, sans-serif; line-height: 17px;">•<span class="Apple-tab-span" style="white-space: pre;"> </span> Quality System</span></span><br />
<span style="color: #333333;"><span style="font-family: Arial, Helvetica, sans-serif; line-height: 17px;">•<span class="Apple-tab-span" style="white-space: pre;"> </span> Facilities and Equipment System</span></span><br />
<span style="color: #333333;"><span style="font-family: Arial, Helvetica, sans-serif; line-height: 17px;">•<span class="Apple-tab-span" style="white-space: pre;"> </span> Materials System</span></span><br />
<span style="color: #333333;"><span style="font-family: Arial, Helvetica, sans-serif; line-height: 17px;">•<span class="Apple-tab-span" style="white-space: pre;"> </span> Production System</span></span><br />
<span style="color: #333333;"><span style="font-family: Arial, Helvetica, sans-serif; line-height: 17px;">•<span class="Apple-tab-span" style="white-space: pre;"> </span> Packaging and Labeling System</span></span><br />
<span style="color: #333333;"><span style="font-family: Arial, Helvetica, sans-serif; line-height: 17px;">•<span class="Apple-tab-span" style="white-space: pre;"> </span> Laboratory Control System</span></span><br />
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<span style="color: #333333;"><span style="font-family: Arial, Helvetica, sans-serif; line-height: 17px;">Most of the systems defined in the six-system model are readily </span></span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">transferable to audit observation categories useful for the inspection </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">of both manufacturing and clinical activities. Many clinical </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">requirements can be integrated into the six-system model. Within the </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">Quality System, observation types such as audit program, complaints, </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">deviations, personnel training and qualification, Standard Operating </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">Procedures, and vendor qualification may be appropriate to both GMP </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">and GCP activities. Audit observation types related to the Facilities </span><br />
<span style="color: #333333;"><span style="font-family: Arial, Helvetica, sans-serif; line-height: 17px;">and Equipment System, such as calibration/preventive maintenance, </span></span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">equipment management, facility security, cleaning, and sanitation </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">may be appropriate to both GMP and GCP functions. However, audit </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">observation types related to contamination controls, environmental </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif; line-height: 17px;">monitoring, HVAC systems and water systems may be used primarily </span><br />
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<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">for manufacturing rather than clinical activities. </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">Although the six-system model provides an excellent starting point, </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">not all clinical audit observations fit well into the six-system model. </span><br />
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<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">The </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">addition of a seventh Clinical System can accommodate the addition </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">of clinical audit observation types within an integrated inspection </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">model. Examples of audit observation types within the Clinical System </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">may include: adverse events, case report forms/source documents, </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">ethics committee, informed consent, monitoring, protocol compliance, </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">regulatory approval, serious adverse events, trial management and </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">oversight, and trial master file. Although it may be appropriate to create </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">additional systems or categories (e.g., to distinguish safety from other </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">trial management activities) for the purpose of this discussion we will </span></div>
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<span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">create only one additional category for Clinical Systems (Figure 1). </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">With the integration of clinical requirements into FDA’s inspection </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">model, and the addition of a Clinical System to accommodate additional </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">GCP observation types, the seven-system inspection model provides an </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">integrated structure of audit observation categories to help achieve the </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">goals of the quality audit program. The use of audit observation terms </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">in the same manner to define, report and compare audit observations </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">promotes improved transparency and communication between GMP </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">and GCP functions, and a more accurate view of compliance across the </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">organization to effectively assess, communicate and resolve compliance </span><span style="color: #333333; font-family: Arial, Helvetica, sans-serif;">issues identified by the quality audit program.</span></div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhCxKnBCuXGjVLkwOZ0RCqakxg1AwbxhkmM1wmf9rjXqpYw3Rdd6vUZj_JtzmJ9ogj9aqZ70sJE-pdOy6iky5SkMaA4UsEieXwYKgSN6xB1LylPgqwnYnnQ5SQSRFlwhcs9Ys_LmUH-nio/s1600/url.jpeg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="" border="0" height="176" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhCxKnBCuXGjVLkwOZ0RCqakxg1AwbxhkmM1wmf9rjXqpYw3Rdd6vUZj_JtzmJ9ogj9aqZ70sJE-pdOy6iky5SkMaA4UsEieXwYKgSN6xB1LylPgqwnYnnQ5SQSRFlwhcs9Ys_LmUH-nio/s320/url.jpeg" title="FDA Proposes New Rule" width="320" /></a></div>
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The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. The proposed regulation would require that clinical studies conducted outside the United States in support of an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be conducted in accordance with <a href="http://www.compliancelogix.com/training/GCPtraining.html" target="_blank">good clinical practice (GCP)</a>, which includes obtaining and documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of study subjects. The proposed rule is intended to update the standards for FDA acceptance of data from clinical studies conducted outside of the United States and to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies. As part of this proposed rule, FDA is also proposing to amend the IDE and 510(k) regulations to address the requirements for acceptance of data from clinical studies conducted inside the United States. The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type.</div>
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The proposed rule is available using the following web link: <a href="http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTMwMjI2LjE1OTc3MDIxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDEzMDIyNi4xNTk3NzAyMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MDQ0MDQzJmVtYWlsaWQ9YnZlbmdyb2ZmQGNvbXBsaWFuY2Vsb2dpeC5jb20mdXNlcmlkPWJ2ZW5ncm9mZkBjb21wbGlhbmNlbG9naXguY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&100&&&http://www.gpo.gov/fdsys/pkg/FR-2013-02-25/pdf/2013-04201.pdf?source=govdelivery"><span class="s1">http://www.gpo.gov/fdsys/pkg/FR-2013-02-25/pdf/2013-04201.pdf</span></a></div>
Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com0tag:blogger.com,1999:blog-3764484426575543295.post-7023901242089995002013-02-15T07:48:00.000-05:002013-02-26T11:57:17.691-05:00Sharpen Your Skills with Online Courses<span style="background-color: white; font-family: 'Lucida Sans', 'Lucida Sans Unicode', 'Lucida Sans Regular', 'Lucida Grande', 'DejaVu Sans', Arial, sans-serif; font-size: 13px; line-height: 16px;">ComplianceLogix referenced in article at HealthCallings.com. </span><span style="background-color: white; font-family: 'Lucida Sans', 'Lucida Sans Unicode', 'Lucida Sans Regular', 'Lucida Grande', 'DejaVu Sans', Arial, sans-serif; font-size: 13px; line-height: 16px;">Read the full article here: </span><a href="http://career-news.healthcallings.com/2013/02/08/sharpen-your-skills-with-online-courses/">http://career-news.healthcallings.com/2013/02/08/sharpen-your-skills-with-online-courses/</a>Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com0tag:blogger.com,1999:blog-3764484426575543295.post-41854343834185953532013-01-16T10:09:00.001-05:002013-02-26T11:56:41.125-05:00Online Six Sigma Training Course Preview (playlist)<iframe allowfullscreen="" frameborder="0" height="344" src="http://www.youtube.com/embed/videoseries?list=PLZZKhARvptnvU4ZNlz3INjP1XCB8KajHC&index=5" width="425"></iframe>Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com2tag:blogger.com,1999:blog-3764484426575543295.post-42259653574532688472012-11-01T09:59:00.001-04:002013-02-26T11:57:00.150-05:00Six Sigma TrainingNew online training courses available:<br />
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- Six Sigma from 50,000 Feet<br />
- Six Sigma Metrics<br />
- Introduction to Lean Six Sigma<br />
- Design for Six Sigma<br />
- DMAIC for Teams<br />
- Introduction to Statistical Process Controls<br />
Introduction to Statistics<br />
- Basic Statistics<br />
- Constructing Control Charts<br />
- Process Analysis Tools<br />
<br />
More information at <a href="http://www.compliancelogix.com/training.html" target="_blank">www.compliancelogix.com/training</a><br />
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Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com1tag:blogger.com,1999:blog-3764484426575543295.post-6754227988799484892012-08-26T12:48:00.000-04:002013-02-26T11:57:47.305-05:00EU releases updated Pharmacovigilance Monitoring PlanThe European Medicines Agency (EMA) has released an updated pharmacovigilance management plan to deal with the introduction and proliferation of unsafe medicines into the EU's pharmaceutical supply chain.<br />
In its 13 August 2012 posting, EMA explained its plan, has been in operation for nearly three years and applies to all medicines approved within the EU, including those approved by the decentralized and mutual recognition procedures. The plan had recently been updated to reflect the EU's new pharmacovigilance legislation, which should allow regulators to responds to serious and potential threats even faster, EMA said.<br />
"Although the management of the large majority of emerging public health concerns related to the use of medicines has been possible by applying so-called routine measures, in a limited number of cases, commonly described as 'crisis' situations, specific measures had to be taken to allow for an efficient management," EMA explained. "This has been possible through the availability of dedicated 'crisis' management plans at national level."<br />
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The Regulatory Network Incident Management Plan (RNIMP) in Theory</h3>
As part of the plan, EMA said it conducts continuous monitoring of serious adverse events to understand their effects on the broader healthcare system—a process it refers to as proactive incident management. By actively monitoring events, it said it hopes to prevent crises from occurring in the first place with the help of a flexible framework that allows for a coordinated and expeditious response. <br />
The agency said signed Memoranda of Understanding between EMA and National Competent Authorities (NCAs) to share EudraVigilance data and other safety data are a strong component of the coordinated response portion of the plan. "This should allow for a more global approach at EU level in relation to the management of 'crisis' situations," noted EMA.<br />
While the plan is intended to cover a range of issues—quality, efficacy and safety concerns among them—EMA said the majority of cases, in its experience, concern pharmacovigilance issues. Many of these problems require an EU-wide response immediately to take a product off the market or conduct more targeted vigilance measures. EMA also noted that emerging issues may be elevated to an EU-wide response if they are deemed to be a serious potential threat.<br />
<h3>
The RNIMP in Practice</h3>
EMA describes the plan as consisting of two pillars of support: a dedicated management structure contained at the EU-wide level and a procedure administered by the former.<br />
The management structure takes a bifurcated approach toward the exchange of information. A Rapid Alert system communicates urgent safety risks to regulators, while a Non-Urgent Information system funnels potentially serious incidences to the same. Both sets are reviewed by the Incident Review Network—a digital network of EU regulators from EMA, NCAs and the European Commission—which then recommends action to the EU crisis management team.<br />
This crisis management team is composed of an EU Executive Task Force charged with confirming a crisis and initiating a response and an EU Operational Task Force charged with responding to the crisis and recommending changes to avoid the crisis in the future.<br />
The entire RINMP involves a seven step process in which it monitors a threat, evaluates it, confirms the threat is a crisis, initiates and monitors a response, confirms the crisis has been abated and takes steps to determine how it could be prevented from happening again.<br />
<a href="http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500130379" target="_blank">Pharmacovigilance Monitoring Plan</a><br />
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-->Unknownnoreply@blogger.com9tag:blogger.com,1999:blog-3764484426575543295.post-79005012144710935222012-05-01T10:15:00.000-04:002012-05-01T10:16:14.530-04:00FDA Issues Final Rule on Clinical Investigator DisqualificationThe U.S. Food and Drug Administration (FDA) announced an amendment that will expand the scope of clinical investigator disqualification. Under this new regulation, if the FDA Commissioner determines that a clinical investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator will also be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. This rule will become effective May 30, 2012.<br />
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The final rule is available using the following web link: </div>
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<span class="s1"><a href="http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTIwNTAxLjcyMjM5MDEmbWVzc2FnZWlkPU1EQi1QUkQtQlVMLTIwMTIwNTAxLjcyMjM5MDEmZGF0YWJhc2VpZD0xMDAxJnNlcmlhbD0xNjg2OTM5NiZlbWFpbGlkPWJ2ZW5ncm9mZkBjb21wbGlhbmNlbG9naXguY29tJnVzZXJpZD1idmVuZ3JvZmZAY29tcGxpYW5jZWxvZ2l4LmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&100&&&http://www.gpo.gov/fdsys/pkg/FR-2012-04-30/pdf/2012-10292.pdf?source=govdelivery">http://www.gpo.gov/fdsys/pkg/FR-2012-04-30/pdf/2012-10292.pdf</a></span></div>Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com0tag:blogger.com,1999:blog-3764484426575543295.post-35832072103757501422012-03-31T14:41:00.002-04:002012-03-31T15:32:02.246-04:00Conducting Effective Clinical Investigator Audits<a href="http://www.compliancelogix.com/" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;" target="_blank"><img alt="" border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhUmlnxMs-bcUi4Rq6FupNAojTLDoW4f43PHGR-dGZHClLwUdlmjqZudIbhp25ak0AnX0kGfhmlczdlbbXVdkH2MPzo5zgqktILsfM3DZFqHWj71il9IiUAh_OvzLUVEeM6JfZn8Pn__QY/s200/clinical+investigator+audit.jpeg" title="Clinical Investigator Audit" width="142" /></a> <br />
<span style="font-size: 11pt;"><span style="font-family: Arial, Helvetica, sans-serif;">The </span></span><span style="font-family: Arial; text-align: justify;">audit of clinical investigator sites is often related to monitoring activities.</span><span style="font-family: Arial; text-align: justify;"> </span><span style="font-family: Arial; text-align: justify;">Like the monitor, an auditor ensures that reported trial data are accurate and complete, and that the trial is conducted in compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements.</span><span style="font-family: Arial; text-align: justify;"> </span><span style="font-family: Arial; text-align: justify;">These activities help to ensure that the rights and well-being of subjects are protected, viable product candidates reach the public with fewer obstacles, and potential risk or liability to the Company is reduced: i.e., protect the patient, protect the product, protect the Company.</span><br />
<div class="MsoNormal" style="text-align: justify;"><br />
</div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: Arial;">Although both the auditor and monitor share these directives, the auditor differs from the monitor in the scope and performance of their work. Whereas an individual monitor may be concerned primarily with overseeing the progress of a clinical trial at a particular investigator site(s), an auditor is guided by the importance of the trial in submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, the level of risks to the trial subjects, and any identified problem(s) with a particular trial or clinical program. The scope of an audit also includes an assessment of monitoring activities as they relate to the conduct of the trial.<o:p></o:p></span></div><div class="MsoNormal" style="text-align: justify;"><br />
</div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: Arial;">To perform this function, the auditor must be independent of the monitoring and QC (Quality Control) functions to reduce any potential bias from experience with a particular study or investigator site and appropriately evaluate the risks inherent to a particular clinical trial relative to concurrent clinical development activities. It is from this vantage point that clinical investigator sites are selected for audit based on criteria defined in the audit plan for the trial.<o:p></o:p></span></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: Arial;"><br />
</span></div><div class="MsoNormal" style="text-align: justify;"></div><div class="MsoNormal"><span style="font-family: Arial;">Auditors are qualified and selected to conduct investigator site audits based on their training and experience. An auditor must be proficient in the practice of audit conduct, particular aspects of the trial and interpreting relevant information to identify compliance trends. Preparation for a clinical investigator audit typically includes a review of the Investigator’s Brochure, Protocol and amendments, Informed Consent Forms, CRF’s (Case Report Forms), CRF completion guidelines, monitoring reports, SAE (Serious Adverse Event) reports, site correspondence and other relevant documentation in the Trial Master File. The audit should be scheduled such that the Principal Investigator (PI), Site Coordinator(s) and other key staff will be available during the audit. The auditor(s) will discuss site performance and any identified issues with the clinical project team prior to visiting the site.<o:p></o:p></span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span style="font-family: Arial;">During conduct of an audit, auditors will perform a detailed review of site regulatory files, informed consent forms, study correspondence, investigational product/material accountability records, and selected patient files including a comparison of information recorded on source documents with data recorded on case report forms. Interviews will be conducted with the Principal Investigator, Study Coordinator and other site staff to discuss trial roles and responsibilities as well as the conduct of study activities, including procedures for gaining informed consent. An auditor should use appropriate interview techniques to gain additional information to identify potential issues and performance trends as well as the attitudes and behaviors that led to any identified data discrepancies or events observed. For example, is the Investigator reluctant to admit or correct mistakes? Is the data recorded deliberately misleading or is it the result of a limited number of staff taking on too large a volume of work? <o:p></o:p></span></div><div class="MsoNormal"><span style="font-family: Arial;"><br />
</span></div><div class="MsoNormal"></div><div class="MsoNormal"><span style="font-family: Arial;">These observations may result in the discovery of protocol violations, discrepancies in data or differences between site staff description and performance of trial activities. It is an essential part of effective audit technique not only to be able to relate individual observations and data points to identify trends and patterns that may seem hidden among individual discrepancies, but to interpret the value and context of these trends relative to the risks to data integrity and compliance for the trial as a whole. <o:p></o:p></span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span style="font-family: Arial;">If illegal or unethical activity is indicated, the auditor should record their observations, safeguard evidence and obtain copies of pertinent records. A key distinction between demonstrating fraud and misconduct on the part of an investigator is the ability to prove intent. Records and testimony collected during an audit may prove essential to being able to make this legal distinction. <o:p></o:p></span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span style="font-family: Arial;">During the audit exit interview, audit findings are presented and specific questions asked by both the site staff and auditor(s) to ensure accuracy. There should be no ‘surprise’ audit findings if an auditor has been communicating effectively with site personnel throughout the conduct of the audit. The auditor should also communicate with investigators and site staff to identify any issues or concerns that may fall within the influence of the Sponsor.<o:p></o:p></span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span style="font-family: Arial;">As a representative of the Sponsor, it is important that an auditor carry out their work in a professional manner. How an auditor conducts her/himself, both on site and in correspondence, could have a potential impact on the liability of the Company. Inappropriate conduct on the part of the auditor may be subject to actions related to securities laws, antitrust laws, violation of due care, or even aiding and abetting. In addition to the standards of ensuring confidentiality and avoiding conflicts of interest, an auditor should not make any promises to site personnel on behalf of the Sponsor or tell auditees how to do their work (thereby inheriting partial liability for work conduct). </span></div><div class="MsoNormal"><span style="font-family: Arial;"><br />
</span></div><div class="MsoNormal"><span style="font-family: Arial;">Audit reports may be notoriously dry and matter-of-fact, but this approach is both to mitigate legal liability and provide a report of site performance with limited bias. </span><span style="font-family: Arial;">It is not enough, however, to just write an audit report and file it away.</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">Timely follow-up and correction of audit observations will help to keep site operations compliant and data accurate.</span><span style="font-family: Arial;"> </span><span style="font-family: Arial;">Particular site observations may indicate more general actions for the study that can improve the compliance, accuracy, speed and/or costs of conducting the trial.</span></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><span style="font-family: Arial;">Conducting effective clinical investigator audits requires auditors to maintain standards of professional conduct and proficiency to provide an independent, unbiased report to management on the conduct of a clinical trial. Clinical investigator audits, as part of an overall quality oversight program, help to effectively manage the risks to trial subjects, ensure data integrity and limit potential regulatory or legal liability associated with the conduct of clinical trials.</span></div>Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com1tag:blogger.com,1999:blog-3764484426575543295.post-32013764603021769232012-03-12T18:40:00.004-04:002012-03-31T15:33:58.709-04:00FDA Guidance: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND<div style="font-family: Arial,Helvetica,sans-serif;">FDA issued the following guidance, "FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions." The guidance is intended to clarify the requirements if 21 CFR 312.120 and it also provides recommendations for IND's or MAA"s on how to provide evidence of GCP compliance of a non-IND foreign clinical study. </div><br />
<span lang="EN" style="font-family: 'Times New Roman', serif; font-size: 12pt;"><a href="http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTIwMzA1LjU5Nzc3NDEmbWVzc2FnZWlkPU1EQi1QUkQtQlVMLTIwMTIwMzA1LjU5Nzc3NDEmZGF0YWJhc2VpZD0xMDAxJnNlcmlhbD0xNjgzNTUyNyZlbWFpbGlkPWFubmlld29vZGxhbmRAY29tY2FzdC5uZXQmdXNlcmlkPWFubmlld29vZGxhbmRAY29tY2FzdC5uZXQmZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&100&&&http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf?source=govdelivery">http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf</a></span><span lang="EN"> </span>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-3764484426575543295.post-71785125420502862182012-02-18T10:10:00.004-05:002012-04-05T02:06:13.313-04:00Free Whitepaper, "Keys to Implementing a Successful Compliance TrainingProgram"<div class="MsoNormal" style="text-align: justify;"><span style="font-family: Arial;">The expectation of any company is to provide training for their employees in order to perform their required functions. Learn about the many aspects to a comprehensive employee training program. Download the whitepaper at </span><a class="twitter-timeline-link" data-display-url="gxptraining.org" data-expanded-url="http://gxptraining.org/" data-ultimate-url="http://gxptraining.org/" href="http://www.gxptraining.org/" rel="nofollow" style="background-color: white; border-bottom-width: 0px; border-color: initial; border-image: initial; border-left-width: 0px; border-right-width: 0px; border-style: initial; border-top-width: 0px; color: #b40006; font-family: HelveticaNeue, 'Helvetica Neue', Helvetica, Arial, sans-serif; font: inherit; line-height: 18px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; outline-color: initial; outline-style: initial; outline-width: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-decoration: none; vertical-align: baseline;" target="_blank" title="http://gxptraining.org/">http://www.gxptraining.org/</a></div>Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com1tag:blogger.com,1999:blog-3764484426575543295.post-20143383339068877042012-02-14T19:26:00.002-05:002012-03-31T15:33:25.826-04:00FDA Guidance: IND Applications for PET Drugs<div class="p1"><span class="s1"></span><br />
<span class="s1">FDA's draft guidance summarizes the investigational new drug application (IND) process for unapproved positron emission tomography (PET) drugs, makes recommendations on how to submit an IND, provides advice on investigational PET drug access options, and describes the process for requesting permission to charge for an investigational PET drug. Read the guidance at www.fda.gov: <a href="http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTIwMjE0LjU1ODAxNjEmbWVzc2FnZWlkPU1EQi1QUkQtQlVMLTIwMTIwMjE0LjU1ODAxNjEmZGF0YWJhc2VpZD0xMDAxJnNlcmlhbD0xNjgyNTI0NiZlbWFpbGlkPWJ2ZW5ncm9mZkBjb21wbGlhbmNlbG9naXguY29tJnVzZXJpZD1idmVuZ3JvZmZAY29tcGxpYW5jZWxvZ2l4LmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&107&&&http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291573.pdf?source=govdelivery"><span class="s2">Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs (PDF - 461KB)</span></a></span></div>Anonymoushttp://www.blogger.com/profile/08016530894584607696noreply@blogger.com1