CC: Clinical Trials Core

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Core C : Clinical Trials The primary objective of the clinical trials core is to provide assistance to the projects in all aspects of clinical trial design, implementation, regulation, data collection, and interpretation, pharmacokinetics, and other specimen collections for targeted therapy investigations and/or banking. Specifically, the clinical trials core facilitates protocol writing and preparation, submission, and regulatory review, interacting directly with the NCI, FDA, Industry sponsors and IRB as needed. The clinical trials core maintains the database and all aspects of data management for patients enrolled on clinical trials within the SPORE. Adverse event reporting and data and safety monitoring for all protocols on the SPORE application are coordinated through the clinical trials core. The clinical trials core seamlessly interacts with the specimen core, providing clinical, epidemiologic and demographic data on patients consenting to tissue banking, and with the biostatistics core, providing timely reports and data for analysis.