Description
The US Food and Drug Administration (FDA) has a comprehensive program of on-site inspections and data audits to monitor the conduct of reporting of FDA-regulated research. The aims of these programs are to provide uniform guidance and specific instructions for conducting clinical investigator inspections and to gather evidence to support the regulatory decision-making process. This course is designed to help clinical investigators understand the goals of the inspections, prepare for them, and how to conduct any post-inspection follow-up.
Attendance at this program has been approved for 0.50 contact hours of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 0.50 hours of CE credit.
Objectives
- Understand the history and importance of the Bioresearch Monitoring Program
- Understand the difference between routine and for cause inspections
- Discover best practices for preparing for an inspection, participating in an inspection, and following up after the inspection.
Certificate
By completing/passing this course, you will attain the certificate Advarra Completion Certificate
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