Abstract: Clinical Protocol and Data Management (CPDM) Clinical Protocol and Data Management (CPDM) at the UPMC Hillman Cancer Center (HCC) is supported by the Department of Clinical Research Services (CRS). CRS facilitates the development, implementation, coordination, internal data monitoring, and completion of both pediatric and adult oncology-focused trials. CRS supports national, external peer-reviewed, institutional, and industry trials at all phases, involving all treatment modalities, with 413 active trials in 2018, including 266 early phase (Pilot, Phase 1/2), 72 Investigator-Initiated Trials (IITs) of which 43 are developed by HCC investigators, and 96 national trials (DT4). HCC accrued 1,843 patients on interventional trials of whom 745 were on therapeutic trials in CY 2018, and 12,752 Interventional accruals of which 4,197 are therapeutic during the current reporting period. CPDM/CRS supports HCC institutional (i.e., investigator-initiated), multi-center cooperative group/National Clinical Trial Network (NCTN), consortium, and industry-sponsored trials. CPDM leadership was modified in 2018 with the appointment of Antoinette Wozniak, MD, an experienced clinical investigator, as the Associate Director (AD) for Clinical Research to oversee the development of the scientific strategy for HCC and the promotion of investigator- initiated clinical research to take advantage of the strong basic and translational scientific programs at HCC. Also new in 2018, Bhanu Pappu, PhD, MHA, joined as the AD for Clinical Research Operations and provides day-to-day administrative oversight of CRS and executes the strategic plan. Since their arrival in 2018, they have streamlined several processes, started new initiatives to decrease clinical trial activation times, increased staff retention, allocated CPDM staff based on trial complexity, strengthened internal audit processes, and enhanced collaborations with the expansive UPMC community oncology practices. Early trends indicate that clinical trial activation times have decreased significantly and patient enrollment on therapeutic clinical trials has increased by 30% in 2019 compared to 2018. Data and Safety Monitoring is an integral part of the CPDM which is overseen by the Data and Safety Monitoring Committee (DSMC) and supported by the internal audit team as well as the Education and Compliance Office of the University of Pittsburgh. An independent safety team ensures that all disease or modality centers (DMC) across HCC follow the same SOPs for patient safety reporting and submits its reports to the DSMC Chair. Participation of women continues to be high (67% accruals in 2018 are women). Minority participation is stable (5.4%) and closer to the percentage of minority patients seen at HCC, but HCC leadership recognized the need and opportunity to increase minority enrollment, hence various strategies to enhance minority trial participation are outlined in Part III of CPDM. The Pediatric Oncology Program...