Regulatory / Legal
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2023 Agenda
Friday, September 29, 2023 at 1:15 to 2:00 Track: Regulatory / Legal
Why Boilerplate Clauses in Clinical Trial Agreements Matter
CTA negotiations are often long, time-consuming, and costly. As a result, many sites simply chose to ignore the boilerplate clauses such as governing law, venue, assignment, survival, force majeure, and others. This can unnecessarily expose the site, the PI, and all study personnel to serious financial risk. This presentation will help identify and describe the key boilerplate clauses in CTAs and will then provide the attendees with suggestions of how to negotiate these clauses in a proper and efficient manner. 409
Presenter: Marlon Rajakaruna, BA, MBA, LLB, CRCP, Lawyer, Kingsgate Legal
Friday, September 29, 2023 at 2:05 to 2:50 Track: Regulatory / Legal
How to Assess Adverse Event Causality in a Clinical Trial
There have been numerous methodological publications for assessing causality in adverse events. The Bradford Hill Criteria is one of the most practical and easy to implement. This presentation will discuss the diverse options for assessing causality and present a pragmatic approach to this important task. 411
Presenter: Gerald Klein, MD, , Principal, MedSurgPI LLC, Adj. Prof. Pharmacology & Toxicology in Brody Medical, School at East Carolina University
Friday, September 29, 2023 at 3:25 to 4:10 Track: Regulatory / Legal
The Difference is in the Details – Drug vs. Device Trials: A Regulatory Perspective
Overview of FDA regulatory requirements for INDs and IDEs is presented as a side-by-side comparison, based on the experience of working mostly with investigator-initiated clinical trials. Drug and device trials have differences. One unarguable similarity they have in common: Patients. Regulations are in place to ensure a well-controlled, properly and ethically run clinical trial, and the patients’ safety. 413
Presenter: Daniel Redline, BA, CCRP, CIP, Senior Director, Global Clinical Affairs, Align Technology
Friday, September 29, 2023 at 4:15 to 5:00 Track: Regulatory / Legal
Overview of Regulatory Requirements of the ClinicalTrials.gov Registration and Results Reporting (PRS) System
The ClinicalTrials.gov Protocol Registration and Results System (PRS) database is the largest national registry of clinical trials and contains data from studies conducted across the world. Attendees will learn why, when, and how to register Clinical Trials in the PRS. Additionally, they will understand how to report the results of their studies in the system. This session is aimed at clinical research team members seeking to learn more about the importance of the regulatory requirements of the ClinicalTrials.gov system. 415
Presenter: Susan Hmwe, PhD, MS, MBBS, CCRP, Manager, Clinical Research Data Quality & Reporting, City of Hope Comprehensive Cancer Center