Clinical trial agreements: Important or just one more study document?

4^th International Conference on Pharmaceutical Regulatory Affairs

September 08-10, 2014 DoubleTree by Hilton Hotel Raleigh-Brownstone-University, USA

JoAnn P Pfeiffer

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

A review of the current literature suggests that the clinical trial agreement (CTA) may be a problematic area for clinical trial investigators. Some experts in the field believe this document is critical to investigator conduct, yet it is one of the least understood study documents, rarely reviewed by investigators, and is often signed without reviewing the content. This key document governs the investigator?s conduct of the study, as does the protocol, investigator brochure, and informed consent. While experts claim this is a problematic area rife for potential conflict between sponsor and investigator that could have serious legal ramifications little or no scientific data to support this belief was found in the literature reviewed. Using social and behavioral methodologies, a survey was constructed to collect data on the factors influence investigators? knowledge, attitudes and perceptions about the CTA. Questions were framed to include all spheres of the Social Ecological Model and to analyze perceptions, beliefs and knowledge as outlined in the Health Belief Model. Surveys were sent to investigators throughout the US, in various clinical trial environments, regions, and organization type. The data collected will help to establish current practices and provide guidance for possible future interventions and additional research. This will be the first public presentation of the data collected to truly determine whether this is a problematic area and if so how severe is the problem.

Biography :

JoAnn P Pfeiffer completed a Doctorate of Science, in Regulatory Science at the University of Southern California and holds masters? degrees in Regulatory Science and Public Health. Her expertise includes clinical trial operations, regulatory compliance, performance management and leadership, conflict management, and contract and budget review and negotiation. She conducted the first systematic evaluation and analysis of the U.S. investigator?s relationship to the clinical trial agreements to provide a better understanding of the current practices of investigators with clinical trial agreements. She holds certifications in regulatory affairs and clinical research. She is a guest speaker for university regulatory classes and clinical trial certification programs. She is a regulatory and compliance consultant for clinical trial sites, research institutions, academic centers, and research organizations.