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Warning Letters to Sponsor-Investigators at Academic Health Centres ? The Regulatory ?Canaries in a Coal Mine? |pdf=|usr=}}{{24309225}} gab.com Text Warning Letters to Sponsor-Investigators at Academic Health Centres The Regulatory Canaries in a Coal Mine JO: Clin Invest Med http://www.kidney.de/pget.php?&tw=1&pmid=24309225 #FOAvip Purpose: This study highlights Warning Letters (WL) findings issued to sponsor-investigators (S-Is) by the Food and Drug Administration (FDA). Methods: The online index of WLs issued from October 1, 2007 through September 30, 2012 was reviewed [1]. Through a manual screening process, letters were evaluated if specifically issued to ?clinical investigators?, ?sponsors? or ?sponsor-investigators?. A particular focus was given to S-Is at Academic Health Centres (AHCs). Each letter was scored for the presence of violations in 40 general regulatory categories. Results: A review of FDA WLs issued over a five year period (FDA Fiscal Years 2008?2012) revealed that WLs to S-Is represent half of the WLs issued to all sponsors (16 of 32 letters). A review of these letters indicates that S-Is are not aware, or simply do not meet, their regulatory responsibilities as either investigators or sponsors. In comparing total sponsor letters to those of S-Is, the most cited violation was the same: a lack of monitoring. A review of publicly available inspection data indicates that these 16 letters merely represent the tip of the iceberg. Conclusion: This review of the WL database reveals the potential for serious regulatory violations among S-Is at AHCs. Recent translational funding initiatives may serve to increase the number of S-Is, especially among Academic Health Centres (AHCs) [2]. Thus, AHCs must become aware of this S-I role and work to support investigators who assume both roles in the course of their research. Twit Text FOAVip Warning Letters to Sponsor-Investigators at Academic Health Centres The Regulatory Canaries in a Coal Mine ????Clin Invest Med http://www.kidney.de/pget.php?&tw=1&pmid=24309225 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=24309225 #FOAvip English Wikipedia <ref>{{Cite pmid|24309225}}</ref> Warning Letters to Sponsor-Investigators at Academic Health Centres ? The Regulatory ?Canaries in a Coal Mine? #MMPMID24309225 O?Reilly EK; Blair Holbein ME; Berglund JP; Parrish AB; Roth MT; Burnett BK Clin Invest Med 2013[]; 36 (6): E290-6 PMID24309225show ga Purpose: This study highlights Warning Letters (WL) findings issued to sponsor-investigators (S-Is) by the Food and Drug Administration (FDA). Methods: The online index of WLs issued from October 1, 2007 through September 30, 2012 was reviewed [1]. Through a manual screening process, letters were evaluated if specifically issued to ?clinical investigators?, ?sponsors? or ?sponsor-investigators?. A particular focus was given to S-Is at Academic Health Centres (AHCs). Each letter was scored for the presence of violations in 40 general regulatory categories. Results: A review of FDA WLs issued over a five year period (FDA Fiscal Years 2008?2012) revealed that WLs to S-Is represent half of the WLs issued to all sponsors (16 of 32 letters). A review of these letters indicates that S-Is are not aware, or simply do not meet, their regulatory responsibilities as either investigators or sponsors. In comparing total sponsor letters to those of S-Is, the most cited violation was the same: a lack of monitoring. A review of publicly available inspection data indicates that these 16 letters merely represent the tip of the iceberg. Conclusion: This review of the WL database reveals the potential for serious regulatory violations among S-Is at AHCs. Recent translational funding initiatives may serve to increase the number of S-Is, especially among Academic Health Centres (AHCs) [2]. Thus, AHCs must become aware of this S-I role and work to support investigators who assume both roles in the course of their research. äWarning Letters to Sponsor-Investigators at Academic Health Centres ? (epmc).pdf DeepDyve Pubget Overpricing