Project Coordination

Study Design

Researchers at the EDC have decades of experience in designing research studies, procuring resources, preparing protocols, and performing all functions required to implement single- and multicenter research projects across a spectrum of application areas. Design components such as defining measures, clearly specifying interventions in the case of a clinical trial, data capture, rigorous quality control processes, appropriate follow-up schedules, and patient eligibility criteria are best addressed by collaboration among clinical and statistical investigators. EDC collaborations with scientists at the University of Pittsburgh, across the country, and around the world  aim to design the most appropriate clinical trial or observational study to address the research question at hand. Beyond the scientific, data management, and technological aspects of study design, Project Coordination also means planning and carrying out the day-to-day operations.  Experienced personnel provide administrative and logistical support that includes arranging meetings and webinars, compiling and circulating documents such as protocols and operations manuals, preparing presentations, and overseeing IRB and other regulatory approvals.

One of the primary roles of the EDC in many cases is to perform data analyses for study presentations and manuscripts. The goal is to perform appropriate, sophisticated statistical analyses that demonstrate clearly the relationships among variables. EDC statisticians perform statistical analyses for all aspects of a study, including interim monitoring reports for Data and Safety Monitoring Boards and for regulatory agencies such as the FDA. The EDC collaborates with research partners so that the analysis results are presented in a comprehendible and interpretable manner.