Clinical Trial Site Audit Preparedness
Clinical trial sites and investigators are routinely audited by their trial Sponsors, CROs, ethics boards and most dauntingly local regulatory authorities (Food and Drug Administration (FDA), Health Canada etc).
The findings uncovered in these audits may have cascading consequences for unprepared sites and investigators. They may lead to the suspension of a trial at a site or even cessation of all research related activities until the findings have been resolved.
This short course has been designed to help clinical trial sites prepare for the possibility of a routine or for cause audit. The information presented in the course outlines the common rational for audit targeting, preparing your site for an audit, hosting the audit through to responding to audit findings and implementing corrective and preventative action.
The course will conclude with a short case study on select audit findings, including root cause determination and the corrective and preventative actions followed to resolve them.
Contributing authors to this course include:
• Lead Canadian / US Good Clinical Practice auditor
• Sponsor Quality Assurance and Clinical Operations Personnel
• Site Clinical Research Coordinators who have undergone Sponsor, IRB and FDA audits
The program is offered in a custom built Learning Management System (LMS) which will track progress of each student and issue a certificate of training for all modules completed. This certificate and syllabus should be retained as evidence of training for sponsors, CROs, ethics boards and regulatory authorities.
This course is offered via an on-line, self-paced eLearning platform. The eLearning environment is custom built to cater to the three primary learning styles, in an engaging setting. Practical job aids are included which can be retained upon course completion for use at your site.
This course has been designed to provide comprehensive, performance based content blended with real world applications. After reviewing the comprehensive content, students will use scenario based learning to apply these skills and ensure retention of the content.
The estimated time to complete this course is 2 hours.
The cost to purchase this course is $125
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