The warning letter is a communication sent to sponsors, manufacturers and clinical investigators resulting from inconsistencies and inaccuracies found during FDA audits of clinical research-related activities. Warning letters to investigators can have a major impact on that physicianââ?¬â?¢s practice and their affiliated institution. The objective of this research was to analyze the publicly available warning letters that were sent to clinical investigators during the years 1996 to 2011 to identify areas of deficiencies and educate current and future clinical investigators. The data was extracted from letters to Clinical Investigators published in the Electronic Reading Room on the FDAââ?¬â?¢s website.The specific regulationslisted in the letters that were deemed violated by the respective FDA auditor were used for data analysis and termed ââ?¬Å?infractionsââ?¬Â.This data shows common deficiencies in clinical research programs and can assist investigators in developing preventative measures for future clinical research.
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