Clinical Protocol and Data Management

$391,491P30FY2020CANIH

University Of Iowa, Iowa City IA

Investigators

Linked publications & trials

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Abstract

Clinical Protocol and Data Management efforts are managed through Clinical Research Services (CRS) of the Holden Comprehensive Cancer Center (HCCC) through two related components - The Clinical Trials Support Office (CTSO) and Data and Safety Monitoring (DSM). These components are critical shared resources that support clinical cancer research including treatment, non-treatment interventional and non-interventional studies conducted by members of the HCCC. They encompass clinical research, regulatory, and data and safety monitoring. This includes investigator initiated trials, NCTN trials, consortium trials, and industry sponsored trials. Services provided by the CTSO related to protocol management include protocol development, protocol routing, protocol IRB renewal, modification and adverse event monitoring. The CTSO also provides trial specific support through staff members that assist in assignment of trials to teams, protocol listing and promotion, accrual tracking, assistance with screening and consenting subjects, data management, quality assurance, and education for early career clinical investigators. DSM is coordinated through a Data and Safety Monitoring Committee.

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