PROTOCOL REVIEW AND MONITORING SYSTEM

$154,758P30FY2016CANIH

Case Western Reserve University, Cleveland OH

Investigators

Linked publications & trials

Paper 39632799 Paper 39604816 Paper 39540668 Paper 39463946 Paper 39450169 Paper 39436709 Paper 39417124 Paper 39368532 Paper 39289460 Paper 39225950 Paper 39211789 Paper 39210605 Paper 39209454 Paper 39122686 Paper 39108243 Paper 39068213 Paper 38970391 Paper 38917791 Paper 38843355 Paper 38837227 Paper 38806481 Paper 38768238 Paper 38766010 Paper 38747616 Paper 38705393 Paper 38658162 Paper 38627584 Paper 38601153 Paper 38528201 Paper 38506663 Paper 38486046 Paper 38446033 Paper 38405739 Paper 38402506 Paper 38378993 Paper 38370781 Paper 38346081 Paper 38345160 Paper 38320468 Paper 38289450 Paper 38245749 Paper 38194275 Paper 38182782 Paper 38170741 Paper 38130180 Paper 38038617 Paper 38023136 Paper 37922427 Paper 37720048 Paper 37713257 Paper 37695687 Paper 37693940 Paper 37669939 Paper 37655165 Paper 37607921 Paper 37515440 Paper 37483595 Paper 37382374 Paper 37380658 Paper 37375634 Paper 37333182 Paper 37296097 Paper 37292931 Paper 37278910 Paper 37221284 Paper 37201585 Paper 37200188 Paper 37184054 Paper 37182784 Paper 37076488 Paper 37011838 Paper 36979465 Paper 36951656 Paper 36868921 Paper 36831350 Paper 36817228 Paper 36811860 Paper 36804445 Paper 36788429 Paper 36696357 Paper 36695968 Paper 36656585 Paper 36644317 Paper 36510003 Paper 36494154 Paper 36399634 Paper 36332544 Paper 36206317 Paper 36200124 Paper 36200123 Paper 36153582 Paper 36138741 Paper 35989341 Paper 35982673 Paper 35945369 Paper 35934060 Paper 35912749 Paper 35895696 Paper 35837788 Paper 35833657

Abstract

PROJECT SUMMARY (See instructions): The Case CCC Protocol Review and Monitoring System (PRMS) is responsible for scientific evaluation, prioritization, and monitoring of all cancer clinical trials conducted at consortium institutions. The PRMS is independent of and complements the activities of the Institutional Review Boards (IRBs) and Data Safety and Toxicity Committee (DSTC). The Case CCC PRMS is operationalized through the Protocol Review and Monitoring Committee (PRMC). The PRMC resides within the Case CCC Clinical Research Office, which oversees and coordinates the activities of the Clinical Trials Core Facility (CTCF), Protocol Review and Monitoring System, Data and Safety Monitoring, and Protocol Specific Research Support. The PRMC supports the clinical research programs of the Case CCC by providing scientific review (and associated feedback to assist in protocol development), establishing priority ranking for protocols within a given disease category and by monitoring the progress and patient accrual. The PRMC membership is selected to ensure diverse expertise relevant to cancer clinical research and is composed of pharmacists, nurses, clinical investigators, biostatisticians, translational PhD scientists and patient advocates from consortium member institutions. The PRMC operates as a single committee across the consortium and has authority to review all new clinical research protocols, including those sponsored by the Cancer Center, NCI, other NIH, industry, foundations, or other sources. These include therapeutic, behavioral, and observational studies. The PRMC has authority for closure of ongoing studies that are accruing slowly and are unlikely to accomplish their scientific goals, and a structured process for accrual evaluation is followed. New protocols, continuing reviews and amendments are evaluated by the PRMC. In 2011, PRMC reviewed 185 new protocols.

View original record on NIH RePORTER →