This course provides a step-by-step outline of internal and external audits as well as ongoing actions that should be taken to prepare for an audit. Topics include types of audits; the audit process (sites, sponsors, CROs); planning/preparing for an audit; rules of behavior during and after the audit; and dealing with the results.
Other Credits: BRN: 8 CE hours.
Note: Prerequisite: Good Clinical Practices (FPM 40204 or equivalent) or 2 years clinical research experience. Elective for Professional Certificate in Clinical Trials Design and Management.
Course Number: FPM-40207
Credit: 1.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management
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10/18/2021 - 11/15/2021