Clinical Core

University Of Pittsburgh At Pittsburgh, Pittsburgh PA

Investigators

Linked publications & trials

Abstract

To ensure patient safety, which is the highest priority of these studies, this clinical core will be responsible for (1) preparation and submission of local, federal, and international regulatory documents, (2) oversight of reporting of adverse events, (2) quality assurance, (3) interim analysis of adverse events and patient outcome, and (4) facilitation of an independent data and safety monitoring board which will evaluate the incidence of adverse events and patient outcomes to determine whether the studies meet pre-specified safety criteria. To perform these functions, the clinical core staff will be administratively, financially, and scientifically independent of the investigators and staff of the molecular biology and clinical trial projects. The independence of the clinical core has been ensured by the PI of the overall project, who has granted the oversight core PI (Tasha Hall) complete autonomy and has empowered her with the right to withdraw active therapy from specific patients and to terminate the clinical studies should they meet pre-specified safety criteria. In addition to working with the PIs of the proposed clinical projects, the clinical core will work with the PIs of the preclinical projects to assist them with moving their work to the bedside. Assistance with statistical manipulation for animal studies and assistance with conversations with members of CBER to ensure that appropriate experiments are being done to move the project to human application. Assistance with collaboration with clinicians and other core laboratories will also be provided.