#1
18th September 2014, 04:02 PM
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BU Auditing Courses
Can you tell me about the Auditing in Clinical Research course offered by Boston University?
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#2
18th September 2014, 04:07 PM
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Re: BU Auditing Courses
The Auditing in Clinical Research course offered by Boston University is as follows: Auditing in Clinical Research Clinical research auditing courses ensures that the rights, safety, and well being of the study subject have been protected and the clinical study data are convincing. Auditing clinical trial activities provides the strict mistake of performance with the goal of having a successful submission and noticeable opportunities for improvement. In this practical course, students learn how to prepare and conduct audits, write audit observations, create an audit report and review audit report responses. Students also learn how to manage audits by an outside agency. Good Clinical Practice (GCP) guidelines and regulatory requirements are reviewed along with exploring the concept of a quality system and the writing of audit program Standard Operating Procedure (SOP). Emphasize is given to Develop an audit plan. Group discussions and role- playing are used to develop practical audit techniques. This prepares a student for an introductory auditing position within clinical research. 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