Management of registries and other longitudinal studies creates unique challenges for sponsors, CROs, and other vendors. Programs of many years’ duration are faced with management and operational challenges. Management challenges include staff turnover at the sponsor as well as CROs and vendors. Proactive management of these staff changes that ensure successful ongoing team interactions is essential to program survival. Maintenance of project document history and documentation is another management challenge for long term programs. Ensuring that project decisions and documentation are well specified and accessible to all relevant stakeholders ensures common understanding and expectations across all stakeholder groups and assists project teams in addressing questions about decisions made by predecessor teams or team members.

Operational challenges for managing long term programs include changes in the marketplace and standards of care. Changes in these over time can significantly impact sponsor needs for data. Additionally data collection tools and strategies can also change significantly over time. Use of sequential adaptive methodology to anticipate potential changes at the program planning stage can facilitate changes as these are required over time.

Finally, challenges can be posed by turnover of site staff site, and long term involvement and enthusiasm of sites can be difficult to maintain. Strategies for successful engagement of sites for the study’s duration, and retraining of site staff over time require upfront planning and ongoing re-examination. Representatives from stakeholder groups including CROs, Other Vendors/Sponsors/Sites will discuss lessons learned from the management of long term programs including strategies that have contributed to successful management as well as pitfalls to avoid in managing future programs.

This audio conference covers:

• Understanding management challenges for operating long term programs
• Understanding range of operational challenges for long term programs
• Identifying key strategies for long term study success
• Practical solutions to address operational and management challenges for long term studies

About the speaker:

Eunice Franklin-Becker, MPH is a Project Manager with Covance Periapproval Services located in Conshohocken, PA. As Project Manager, Ms. Franklin-Becker develops project-specific procedures and diagnostic specifications and supervises Clinical and Registry Research Associates and project support personnel. She also oversees investigator selection and protocol performance, as well as Case Report Form and Analysis Plan development.

Ms. Franklin-Becker has nine years of prior clinical research experience and prior to joining Covance, worked at the University of Pennsylvania's School of Medicine in the Center for Clinical Epidemiology and Biostatistics where she held the position of Project Director for the Chronic Renal Insufficiency Cohort Study. She holds a Bachelors of Arts degree in History from The University of Pennsylvania and a Masters of Public Health degree from Emory University. She has also completed doctoral coursework at the Johns Hopkins University Bloomberg School of Hygiene and Public Health.

Who should attend?

• Clinical Project Managers
• Clinical Project Directors
• Senior CRA
• Project Managers
• Registries
• Observational Studies
• Data Management
• Program Operations/Clinical Operations

This audio conference is rated General Interest.

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.