Frederick W. Luthardt, Jr., D.Be., MA (he/him/his)

Johns Hopkins University School of Medicine
Baltimore, MD

Frederick W. Luthardt, Jr., D.Be., MA, Director, Compliance Monitoring Program, Johns Hopkins University School of Medicine, Office of Human Subjects Research, has been involved in clinical research as a study coordinator, investigator, research oversight and compliance expert, educator, and ethicist. Fred has been specifically engaged in post-approval monitoring activities as part of the Johns Hopkins IRB since 2004. Fred currently advises and consults with researchers in designing and implementing quality management systems, including internal monitoring and auditing procedures. Also, Fred provides guidance and assistance to investigators in the development of Data Safety Monitoring Boards and charters. Fred has presented many education and training sessions in research oversight, investigator responsibilities, and research ethics for the Johns Hopkins University schools of Medicine, Nursing, and Public Health.

Presentation(s):

• G16 - [IN-PERSON/RECORDED] ICH E6 Good Clinical Practice (GCP) Training: Programs‐‐Approaches to Achieving Training Compliance Certification for Researchers

  Wednesday, December 6, 2023
  11:30 AM – 12:30 PM ET

• H05 - [IN-PERSON/RECORDED] Postapproval Monitoring (PAM) for Studies Overseen by a Single External IRB of Record: Challenges forLocal Monitoring Programs

  Wednesday, December 6, 2023
  1:45 PM – 2:45 PM ET