Inspection Audit Preparation

$99.00

Clinical trial sites and investigators are routinely audited by their trial Sponsors, CROs, ethics boards regulatory authoritiesThis short course has been designed to help clinical trial sites prepare for the possibility of a routine or for cause audit.

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Clinical trial sites and investigators are routinely audited by their trial Sponsors, CROs, ethics boards regulatory authoritiesThis short course has been designed to help clinical trial sites prepare for the possibility of a routine or for cause audit.

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.

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

Price: $99

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