Decentralized Clinical Trials

Download Breakout Session Overviews  |  Download Schedule of Breakout Sessions  |  View Conference Schedule

2024 Agenda

Sat., Sept 28 1:40 to 2:25                                     Track: Decentralized Clinical Trials

Role of the HRPP in the Assessment of Decentralized Clinical Trials

Ms. Coleman will discuss and provide an overview of the role of the human research protection program to assist in the assessment of Decentralized Trials. The presentation will share possible models for leveraging the HRPP for assessing DCTs and discuss case studies and lessons learned regarding the role of the HRPP in the review of DCTs. 225

Presenter: Linda Coleman, BPharm, JD, CIP, CHC, CHRC, CCEP-I, Associate Vice Provost, Research Policy & Integrity, Stanford University

Sat., Sept 28 2:30 to 3:15                                     Track: Decentralized Clinical Trials

The ABCs and GCP of Successfully Implementing Decentralized Trials

In May 2023, the FDA issued draft guidance for decentralized clinical trials. Initially embraced as a means to adapt to lockdown conditions during the pandemic, the benefits of remote clinical trial models, including greater operational flexibility, access to diverse populations of study participants, and cost savings are now widely accepted. However, as sites have more opportunities to participate in decentralized trials it is important to be cognizant of the potential GCP risks and measures sites can take to ensure participant rights, safety, and data integrity. 227

Presenter: Lisa Harewood, CCRP, Senior Clinical Trials Regulatory Specialist, Hope Clinic of Emory Vaccine Center

Sat., Sept 28 4:35 to 5:20                                     Track: Decentralized Clinical Trials

Clinical Research in Functional Medicine

Mr. Wehage will discuss the perspectives of a very rural community that has been involved with clinical trials for about eight years. 231

Presenter: Scott Wehage, MS, CCRP, Director, Clinical Trials