FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
A Food and Drug Administration (FDA) inspection of a clinical investigator can occur at any time. The FDA conducts inspections of clinical investigators to verify clinical trial data submitted to FDA; to ensure that the rights, safety, and welfare of human subjects enrolled in FDA-regulated clinical trials are protected; and to assess regulatory compliance. By understanding the clinical investigator inspection process and learning how to address inspectional findings, your involvement in an FDA inspection could be transformed into a less stressful and more positive experience.
In this webinar, Advarra’s Constance Cullity, Senior Director, Regulatory Compliance, and Michele Russell-Einhorn, Chief Compliance Officer and Institutional Official, will provide an overview of the clinical investigator inspection process and what to expect.
- Identify the types of clinical investigator inspections: routine and for-cause
- Outline the inspection process and what information will be evaluated and considered during an inspection
- Summarize best practices for addressing inspectional findings during and after an inspection
Senior Director, Regulatory Compliance
Chief Compliance Officer and Institutional Official
Who should watch?
This content applies to principal investigators; sponsors and sponsor-investigators; regulatory affairs representatives; research operations personnel; and others involved in research compliance from sponsors, CROs, and investigative sites.
Attendance at this session has been approved for 1.00 contact hour 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 1 hour of CE credit.
If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.
Certificate of Attendance
After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.
DATE: April 8, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour