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INFORMATION FOR

Protocol Life Cycle Subcommittee

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. View our 2020 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.

View 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.

View Scientific Progress Policy>>

View Guidelines for Submissions of Scientific Progress Reports>>

PLCS 2021 Schedule>>

Contact

Protocol Life Cycle Subcommittee

Chair: Alessandro Santin, MD


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