The three major functions of the CRO are to:
To support these functions, the CRO provides clinical trials administration to assist in the preparation and processing of all regulatory, contractual, and Institutional Review Board (IRB) documents related to institutional, cooperative group and pharmaceutical sponsored protocols for members of the UMMCCoE. The protection of human subjects is of paramount importance to the office, and a team of Regulatory Coordinators assist investigators with IRB submissions including new projects, continuing reviews, protocol revision, and adverse event reporting. Clinical trials coordination and data management are provided by research nurses, clinical research coordinators (CRCs), and data managers who work with the clinical care team to directly coordinate and facilitate all activities for patients involved in clinical research trials. The clinical research staff is divided into disease-based teams. Each clinical trial is assigned to an UMMCCoE principal investigator (PI) and a CRC or research nurse; this research team is responsible for study coordination and data management of all aspects of that protocol.
The CRO of the UMMCCoE is a shared resource that provides clinical research support services to investigators conducting cancer relevant clinical research. The CRO currently serves this function for the UMass Memorial Medical Center (Worcester, MA) and HealthAlliance Hospital (Leominster and Fitchburg, MA). Ultimately, research oversight will extend to other UMass member hospitals: Clinton Hospital (Clinton, MA), Marlborough Hospital (Marlborough, MA) and Wing Hospital (Palmer, MA). As such, the office coordinates the vast majority of adult clinical research conducted in medical oncology, malignant hematology, benign hematology, neuro-oncology, radiation oncology, surgical oncology, and chemoprevention. The CRO is also coordinating non-Children Oncology Group (COG) studies for Pediatric Oncology. Additionally, the CRO serves as the coordinating office for studies conducted for the Eastern Cooperative Oncology Group (ECOG) and other National Cancer Institute (NCI) study groups and consortiums.
In addition to these direct clinical trial services, the CRO provides administrative support for three committees: 1) the Protocol Review Committee (PRC), 2) Data Safety Monitoring Committee (DSMC), and 3) the Governance Committee. These committees are multi-specialty in members, which includes significant interaction with the quantitative health statistics (QHS) and biostatistics faculty at UMASS Medical School (UMMS). The office also employs a Cancer Center/CRO Administrator and a Senior Research Nurse who interact closely with the investigators and oversee all CRCs, research nurses, regulatory coordinators, and other administrative staff. Together, with support from the UMMS Office of Clinical Research they also oversee the overall quality of the work product of the CRO and for implementing Standard Operating Procedures (SOPs) and formalized training.