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Protocol Life Cycle Subcommittee of the PRC (PLCS)

Purpose/Mission

Protocol Life Cycle Subcommittee (PLCS) of the Protocol Review Committee (PRC) is responsible for monitoring the accrual and scientific progress of all active interventional cancer clinical trials. This is facilitated through review of scientific progress and a report of accrual for all active interventional clinical trials. The subcommittee is comprised of senior members of the PRC and meets every other month to review closure recommendations and reports of scientific progress.

2019 Meeting Schedule 

Accrual Monitoring

PLCS will monitor accrual for active interventional cancer clinical trials, except for trials of rare diseases or rare molecular sub-types, on a monthly basis. Study teams must enter accrual targets for trials with dose escalation and dose expansion phases in OnCore according to the Protocol Life Cycle Subcommittee OnCore Instructions for Dose Escalation/ Dose Expansion Studies to ensure PLCS can accurately monitor the accrual targets.

Low accruing studies will generate a letter to the Principal Investigator (PI) asking for an explanation and plan to improve accrual. The PI must then direct the response to the Protocol Life Cycle Subcommittee that stipulates plans for improving accrual rates and study completion timelines. An adequate response may include, but is not limited to, a change in methods for identifying potential subjects and/ or adding collaborating sub-investigators. If there has been no improvement in accrual after the initial review, the PRC may vote to close the study based on PLCS recommendation. PLCS may grant studies in rare diseases, orphan populations or rare molecular subtypes additional time to accrue subjects per committee discretion.

Accrual Monitoring Policy

Scientific Progress

PLCS will review reports of scientific progress for active interventional cancer clinical trials annually. Trials that are no longer scientifically relevant or that will not meet their scientific objective(s) may be recommended to the PRC for closure to further accrual. The PRC may vote to close the study based upon the PLCS recommendation. 

Scientific Progress Policy

Guidelines for Submissions of Scientific Progress Reports

Scientific Progress Report Form

Protocol Life Cycle Subcommittee

For information contact:

Dismayra Martinez, MHE, CCRP
Research Oversight Committee Regulatory Analyst
Yale Center for Clinical Investigation
2 Church Street South, Suite 409
203.737.3537  
plcs.ycc.committees@yale.edu

Niece Hanna, MSW 
Research Oversight Committee Regulatory Analyst  
Yale Center for Clinical Investigation  
2 Church Street South, Suite 409 
203.785.7408    
plcs.ycc.committees@yale.edu