Protocol Specific Research Support

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Protocol Specific Research Support (PSRS) functions include patient recruitment, screening, compliance monitoring, and data collection and dissemination for pilot and innovative CCCWFU institutional studies. The five key functions of the resource follow: 1) Patient Recruitment- Research Nurses evaluate patients (new and existing) for potential protocol eligibility; assist physicians in obtaining all necessary lab work to document eligibility; obtain IRB approved informed consent, work with the Registrar (who verifies eligibility before the accrual is entered into the ORIS database, & ensure that the proper randomization occurs when applicable. 2) Data Capture - All PSRS staff monitor chemotherapy administration, dose modifications, toxicity and patient response; complete all forms (flowsheets) deemed mandatory within the protocol using appropriate source documents; and enter data into the Oncology Research Information System (ORIS) database. The Data Manager uses the ORIS query system to monitor and track requirements for patient data governed by the protocol specific requirements which have been noted in the ORIS database. 3) Protocol Compliance - PSRS staff order appropriate laboratory and diagnostic tests at time intervals specified within the protocol and assist with chemotherapy dose modification when needed to meet protocol requirements. These functions are aided by an ORIS "greensheet" program which generates visit specific requirements, which are printed on "greensheets" and placed on the face of the patient's chart as a reminder to physicians and staff of actions required, and to query physicians during the course of treatment for response, evaluations of toxicity, and any treatment modifications specified in the protocol. 4) Quality Control-The Research Nurses and Data Manager Monitor protocol compliance throughout the course of patient treatment through review of patient charts prior to each scheduled protocol patient visit. This is also done formally at 1st & 3rd patient accrual for institution intervention trials. A review is performed once the first patient is consented to the protocol. The Asst Project Manager (Eagle) and the assigned CRA will check to make sure that all required data elements have been captured. 5) Data and Safety Monitoring - The Research Nurses and Data Manager monitor data collection/reporting and patient safety, acting as the institution and CCCWFU's first detection points for Serious Adverse Events (SAEs). These nurses immediately alert the appropriate PI and Director of CRM and coordinate adverse event tracking reporting with members of CROC and the CRM Shared Resource.