The goal of the Clinical Core is to: (1) assist in clinical trial design; (2) maintain the appropriate regulatory infrastructure and ensure compliance at the local, state, and federal levels for proposed and future clinical trials; (3) interface and data transfer to the private CRO and National PEGT data management specialists. Patients in three clinical trials will be treated at Stanford University or The Children's Hospital of Philadelphia. While record keeping will ultimately be the responsibility of the center in which the patient is treated, Stanford University will serve as the lead Center for maintaining the overall organizational framework of the trials through the Core. While the GCRC at Stanford University will serve as the physical site of the Clinical Core, participants from both institutions are represented. A description of the GCRC at Stanford and a brief summary of the GCRC at CHOP follows. The duties of the clinical core is described herein.
Showing the most recent 10 out of 36 publications