, Protocol Review and Monitoring System (PRMS) The Scientific Review Committee (SRC) and Protocol Progress Committee (PPC) comprise the Protocol Review and Monitoring System (PRMS) for the Indiana University Melvin and Bren Simon Cancer Center (IUSCC). The SRC and PPC focus on the following three specific aims:
Aim 1 : To ensure the IUSCC prioritizes and conducts impactful trials with high scientific merit. The IUSCC prioritizes Investigator Initiated Trials (IITs) > national cooperative group > industry-sponsored trials. Initial responsibility for prioritization rests with the disease-oriented teams (DOTs). DOTs review proposed trials in the context of their programmatic goals and their current trial portfolio. In addition, DOTs analyze patient volumes and accrual to current/recent trials to ensure the accrual goals are reasonable and adequate. Once a DOT has agreed to support a trial, the full protocol, consent, and all supporting documents, along with the feasibility checklist and prioritization scorecard are submitted to the SRC for review. SRC review focuses on scientific merit, but also ensures that the DOTs have appropriately prioritized trials and managed any conflicts. Trials submitted to the SRC by an investigator or DOT that has had a trial closed for low accrual within the previous three years require additional justification of the accrual estimates.
Aim2 : To facilitate rapid activation by conducting efficient and timely review of new protocols. The goal of the PRMS is to conduct reviews in an efficient and timely manner to support rapid activation of high priority trials. To enhance efficiency, beginning in January 2018 the SRC meets twice a month. The SRC uses e-PRMS, a paperless committee management system which is housed within OnCore. The online submission and review console offers immediate access to electronic protocol documents, eliminating the need to track, copy, and collate multiple binders for reviewers. Reviewers submit comments at least 48 hours prior to the meeting which are forwarded to the PI, who can respond prior to the meeting if possible. Concurrent scientific and feasibility review facilitates rapid activation while minimizing resource utilization until feasibility is assured.
Aim 3 : To maximize the use of resources by monitoring protocol accrual and progress. Once approved, the PPC monitors protocol progress and accrual. Protocols not reaching the minimum accrual target are subject to closure by the PPC. High priority IITs and trials in rare populations are granted additional time to meet accrual goals, but still must make progress to avoid closure. The PPC is a subcommittee of the SRC and meets concurrently with the SRC, increasing reviewers' awareness of the resources lost to low accruing trials.
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