Core--Clinical

Johns Hopkins University, Baltimore MD

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): The Clinical Trials Core is a multidisciplinary effort designed to support the translational research of this SPORE. This resource will provide assistance in the design, conduct, and analysis of the clinical trials conducted within the spore. Specifically, assistance with translating laboratory findings into questions answerable within a clinical trial, clinical trial development, regulatory assistance with IND and IRB approvals, and clinical trial conduct will be provided. The core will provide research nursing, data management, adverse event reporting, and trial monitoring for the clinical trials. The core will assure the safety and confidentiality of the data within a pre-existing relational database with web interface. This core will support the laboratory core by managing the human investigation issues including obtaining informed consent from patients for the human tissue repository. The Core is directed by an experienced lymphoma clinical investigator with prior experience in database design. The Core Co-investigator is an experienced laboratory and clinical investigator experienced at moving laboratory findings into the clinic. Staff include Society of Clinical Research Associates certified data managers and experienced research nurses.