Tools and Techniques for Effective Clinical Research Start-up at an Academic Medical Center

Michael Mapel, CCRP
Clinical Research Lead
UCLA Pediatrics Office of Finance & Research Children’s Discovery & Innovation Institute1

Abstract: Activating a clinical research project at an academic medical center requires significant planning and effort from study teams. Research sponsors often have difficulty understanding any process lacking in consistency and transparency and so start-up becomes a barrier to study enrollment. This article breaks down such barriers by advocating specific project management and communication tools and techniques that accelerate the study start-up process without sacrificing quality.

Declaring Goals for Study Start-up

Study start-up is the project calibration stage of any clinical research project. There are many rules, regulations, and processes to be followed when conducting clinical research, and so it is essential to first have a strategy for successful completion of a project.

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Budget Development and Negotiation for Investigative Sites

Budget Development and Negotiation for Investigative Sites

Author: Anna K. Rockich, MS, Pharm D, Director, General Surgery Research Program, University of Kentucky Medical Center

Abstract: Effective budget development and negotiation is critical for investigative sites. This article provides an overview of budget requirements for the conduct of a study, identifies common mistakes in developing budgets, and highlights how to effectively develop the budget and negotiate with the sponsor. Tools to assist in managing the budget on a daily basis are provided.

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Developing Effective Study Start-up Processes

Clinical research start-up study

Jennifer Goldfarb, CCRP
Senior Director, Clinical Research Support Office
Children’s Hospital of Philadelphia            

Grace Wentzel, CCRP
Director, Clinical Research Services
The Research Institute at Nationwide Children’s Hospital

Abstract: The study start-up process sets a study up for success or failure. This article provides an overview of study start-up, the players on the study team, and the infrastructure required for successful study start-up. Tools for the study feasibility assessment for dissecting and implementing the protocol and for ensuring compliance are described. Challenges to study start-up and solutions to those challenges are provided.

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