Development and Implementation of Clinical Research
The CRCU has been structured as a pool of specialized professionals that work on several research projects simultaneously. Each individual in the CRCU is part of a technical division that provides a shared experience base along with specific tools to allow the effective completion of their respective portion of a project. The CRCU maintains a set of Standard Operating Procedures that promote consistency and uniformity across research projects and that allow the CRCU to develop and implement clinical studies in compliance with federal and international regulations and guidelines. This standardization of work across projects also ensures that professional activities are consistent with sponsor and professional standards. In addition, the technical division structure serves to lower costs to a project through the sharing of project experience, resources, and methodologies. This structure allows an individual project to benefit from a wider variety of expertise compared to hiring full time staff for the project.
At the start of a project, personnel from each technical division who are most suited to and who are most experienced with the type of clinical trial being developed are selected and formed into a project team. Division representatives lend their specialized, professional knowledge to the development and implementation of a clinical trial. This team of computing and data management professionals interacts with the scientific team, comprised of the biostatisticians, epidemiologists, and clinicians, to actually implement the scientific concepts contained within the trial research plan.
Project Operations and Compliance personnel serve to coordinate activities between the technical implementation team, the scientific team and other organizational bodies, and ensure that appropriate compliance measures are followed.
Clinical Data Management personnel examine the scientific protocol and develop the data management processes most appropriate for conducting the study.
Research Technologies personnel design and develop the underlying database and administrate the use and security of the database as well as utilize specialized methodologies to develop software. They also develop the electronic DMS, which allows Clinical Center and Data Management personnel to accomplish the tasks associated with conducting the project.
Biomedical Research Computing personnel design and develop physical networking schemes and systems to support the computing equipment associated with the DMS.
