US Department of Health and Human Services, National Institutes of Health, National Institute of Mental Health

NIMH Global Mental Health Webinar Series - July 14, 2016

About the Presentation

Good Clinical Practice for Conducting Clinical Trials Research in Low- or Middle-Income Countries
This webinar is designed as an introduction to Good Clinical Practice (GCP) standards for conducting clinical trials research worldwide. Attendees of this webinar will learn about the ethical basis for GCP standards, relevant regulations and guidelines, investigator responsibilities, essential documentation, the informed consent process, adverse event reporting, and other key issues in conducting high-quality clinical research. This webinar will also discuss common issues encountered in the National Institute of Mental Health (NIMH) Global Hubs clinical trials. The webinar will include time for Dr. Kennedy and Ms. Gilardi to share resources and respond to attendees’ questions.

About the Speakers

Katelyn Gilardi Katelyn Gilardi
Clinical Research Monitor
Office of Clinical Research
National Institute of Mental Health

Katelyn Gilardi is a certified clinical research monitor at the NIMH Office of Clinical Research. She conducts on-site initiation visits, interim monitoring visits, and close-out visits for NIMH-funded studies across the United States. Katelyn has extensive experience monitoring pharmaceutical, device, and psychosocial studies. Before joining NIMH, she was a clinical research monitor at Massachusetts General Hospital and a clinical site operations specialist at Ora, Inc.

Ashley Kennedy, Ph.D. Ashley Kennedy, Ph.D.
Clinical Advisor
Office of Clinical Research
National Institute of Mental Health

Dr. Ashley Kennedy is a Clinical Advisor for NIMH’s Office of Clinical Research in the Clinical Trials Operations and Biostatistics Branch (CTOBB). In this position, she supports extramural clinical trials and provides clinical trials operations expertise to NIMH-funded trials, ensuring quality oversight to ensure successful implementation of clinical trial start-up, conduct, and close-out per GCP/Regulatory systems and data integrity systems. She currently serves as CTOBB operations staff to the RedeAmericas, SHARE, and PaM-D Hubs.