In 2008, a clinical research organization was created to ensure that these trials are ethically and efficiently managed with the ultimate goal of improving the overall quality of the patient care experience and providing the highest quality clinical research environment possible.
In conjunction with the Duke Office of Clinical Research (DOCR), each academic department or therapeutic area established a Clinical Research Unit to oversee all clinical research requiring IRB approval. The Children's Clinical Research Unit (CCRU) is specific for the Department of Pediatrics.
Each Clinical Research Unit (CRU) has specific key components including:
- Faculty members in a particular therapeutic area who are enrolling Duke patients in clinical research studies that involve medical care
- Study coordinators and research staff who are specifically aligned with this faculty group
- A faculty advisory board
- A director (usually a faculty member)
- A research practice manager
- A finance practice manager
However, because of the diverse nature of research at Duke, departments have defined individual operating models that work most effectively in their respective areas. To ensure consistency and clarity of responsibilities and procedures within the Department of Pediatrics, a set of Guidelines, Forms, and Announcements for all pediatric clinical research investigators have been developed. [Note: Login is required to access this information.]