Objective: The overall purpose of QA DSM Shared Resource is to insure the highest quality, safest, most precisely performed clinical cancer research at the UCCC. Structure and services: The overall goal of QA and DSM for the University of Colorado Cancer Center (UCCC) remains twofold: 1) insure the safety and ethical treatment of all human subjects participating in research;2) verify the accuracy, completeness, validity and integrity of all data_collected. Multiple committees and processes contribute to the achievement of these goals. UCCC Protocol Quality Assurance and Safety Committee (PQASC) oversees all aspects of the process within the UCCC Clinical Investigations Core Shared Resource (CICSR) and reports to the Executive Committee of the UCCC, and to COMIRB;and oversees reporting of AEs and SAEs to sponsors and federal agencies, e.g., NCI AdEERs. Collaborative efforts to improve the efficiency and accuracy of the clinical trials process at UC Anschutz Medical Campus (AMC) and UCCC continue through UCCC CICSR interactions with COMIRB including the Director of COMIRB (Alison Lakin, RN, PhD), the Associate Vice Chancellor for Compliance (Angela Wishon, JD) and other groups such as the School of Medicine Clinical Trials Research Advisory Committee (CTRAC) and importantly the protocol review and monitoring committee (PRMC) of the UCCC. These collaborations have contributed to the successful CTSA application in 2008 (Colorado Clinical Translational Sciences Institute). The CICSR Education Committee identifies develops and offers a variety of instructional activities to improve the l The aims of the education activities are to insure high quality conduct and analysis of clinical trials and the specific objectives remain as presented in the Competing Renewal. Four subcommittees provide the needed training: oversight continuing education, orientation and competency Utilization: All UCCC human subject research is subject to oversight by this core. Audits of selected trials, especially investigator-Initiated, are conducted periodically, and the PQASC of this core also provides a data safety monitoring board (DSMB) for trials which do not have a designated DSMB.

Public Health Relevance

At the University of Colorado Cancer Center (UCCC) we take patient research (clinical trials) safety very seriously. We have specific body called the Quality Assurance (QA) / Data Safety Monitoring (DSM)for this purpose. The mission of QA DSM Shared Resource is to insure the highest quality, safest, most precisely performed clinical cancer research at the UCCC grant applications or industry.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA046934-25
Application #
8567547
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2013-02-01
Budget End
2014-01-31
Support Year
25
Fiscal Year
2013
Total Cost
$102,482
Indirect Cost
$33,644
Name
University of Colorado Denver
Department
Type
DUNS #
041096314
City
Aurora
State
CO
Country
United States
Zip Code
80045
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