The YCC Protocol Review and Monitoring System (PRMS) provides critical oversight of all cancer clinicaltrials conducted in the YCC. The PRMS. is made up of three main elements, which include the ClinicalResearch Steering Committee (CRSC), the Protocol Review Committee (PRC), and the Quality Assurance,Compliance, and Safety Committee (QUACS). The CRSC and PRC are responsible for scientificprioritization and review of clinical trials prior to activation. The QUACS focuses on data and safetymonitoring and closely monitors scientific progress, accrual of activated trials, overall quality control andpatient monitoring, and deals with all issues relating to quality assurance and auditing. The QUACS functionsand activities are described in more detail in Section 12. An Oversight Committee composed of the YCCDirector and Senior Leadership provides a mechanism for appeal of decisions made through the PRMS.Since the last CCSG application in 1998, the PRMS has been significantly re-organized, enhanced, andexpanded to provide a more rigorous scientific review of proposed clinical trials; to enhance and ensureappropriate statistical input during the review of clinical trials; to provide a comprehensive process forprioritization of clinical trials, and in particular, to allocate YCC resources to support investigator-initiatedclinical trials; to ensure timely scientific monitoring of activated trials; and to enforce closure of poorlyaccruing trials.A new YCC Office of Protocol Review and Monitoring (OPRM) was created to provide and unifyadministrative support to the three PRMS Committees. A senior physician, Dr. Mario Sznol, with extensiveexperience in conducting and monitoring clinical research was recruited to provide medical leadership of theOPRM and to chair the PRC and QUACS. To complement physician leadership in this office, an experiencedsenior clinical research professional, Susan Anderson R.N., was appointed to be Operations Director of theOPRM. The OPRM supports the activities of the CRSC, PRC and QUACS Committees; maintains a trackingdatabase for protocol reviews and approval, safety data submission, annual review submissions, andcompliance audits; generates minutes for the CRSC, PRC and QUACS meetings; maintains a protocolpriority list; tracks and files correspondence with investigators; contains the auditing function of the YCC, andconducts a rigorous training program for the clinical research staff in managing clinical trials and complyingwith regulatory requirements. A major initiative of the OPRM was to expand the membership and expertise ofthe PRC and to incorporate and establish a robust process for statistical input and review of trial. Futureplans include recruitment and training of new PRC members, as well as training of fellows and junior facultyin methods of clinical research and review of clinical research.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA016359-29
Application #
7513334
Study Section
Subcommittee G - Education (NCI)
Project Start
2007-08-09
Project End
2012-07-31
Budget Start
2007-08-09
Budget End
2008-07-31
Support Year
29
Fiscal Year
2007
Total Cost
$41,299
Indirect Cost
Name
Yale University
Department
Type
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
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