# Clinical Protocol and Data Management > **NIH NIH P30** · MEDICAL UNIVERSITY OF SOUTH CAROLINA · 2024 · $315,096 ## Abstract CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM): SUMMARY Part I: Clinical Protocol and Data Management. The Clinical Protocol and Data Management (CPDM) function is supported through the concerted efforts of the Hollings Cancer Center (HCC) Clinical Trials Office (CTO), the HCC Quality Assurance and Education (QAE) unit, and the HCC Data Safety and Monitoring Committee (DSMC). The CTO provides centralized research services and oversight for coordinating and reporting on all oncology-related clinical trials at the Medical University of South Carolina (MUSC). Between 2018 and 2022, HCC recruited 8,962 individuals into all clinical research studies (1,080 interventional treatment, 4,528 interventional non-treatment, and 3,354 non-interventional accruals), and activated 338 studies, of which 85 studies represent institutional or external peer sponsorship. Part II: Data & Safety Monitoring. HCC’s institutional DSMP was last approved by the NCI in November 2022. The goals of the HCC DSMP are to ensure that Cancer Center research studies are conducted in compliance with federal and institutional requirements to ensure the safety and welfare of human participants. The QAE unit provides internal monitoring activities of PRC-approved trials in accordance with a risk-based monitoring plan, while the DSMC focuses quality assurance and safety monitoring upon MUSC investigator- initiated interventional trials. Part III: Inclusion of Women and Minorities in Research. Under the ongoing active surveillance leadership of HCC and guidance from Community Outreach and Engagement (COE), CPDM supports diverse clinical trial accrual comparable to HCC’s diverse patient catchment area. Twenty-six percent of all trial accruals between 2018 to 2022 represented minority populations (21% Black/African American; 3% Hispanic White; 2% other or more than one race). South Carolina (SC) Census Data reveals that 51% of the state population is female. SC state registry data indicate 48% of female cancer cases, while 53% of HCC patients are female. Overall female trial accrual in CY2022 was 55%. By trial type, females were represented in 35% of treatments, 60% of interventional non-treatment, and 55% of non-interventional trial accrual. Part IV: Inclusion of Individuals Across the Lifespan in Clinical Research. HCC accrues patients to clinical trials across the age continuum. In CY2022, sixty-two new pediatric patients were diagnosed and/or treated for the first time at MUSC, and a total of 97 pediatric patients were enrolled in clinical trials (23 treatment, 28 interventional non-treatment, and 46 non-interventional. Per SC Census Data, individuals 65 years and older make up 19% of the state population. SC state tumor registry data indicate 55% of cancer cases are elderly, while HCC’s tumor registry is 59% elderly. In CY2022, 800 elderly patients age 65 and older were enrolled in clinical trials (145 treatment, 182 interventional non-treatment, 473 non-interventional). ## Key facts - **NIH application ID:** 10847774 - **Project number:** 2P30CA138313-16 - **Recipient organization:** MEDICAL UNIVERSITY OF SOUTH CAROLINA - **Principal Investigator:** David T. Marshall - **Activity code:** P30 (R01, R21, SBIR, etc.) - **Funding institute:** NIH - **Fiscal year:** 2024 - **Award amount:** $315,096 - **Award type:** 2 - **Project period:** 2009-04-01 → 2029-03-31 ## Primary source NIH RePORTER: https://reporter.nih.gov/project-details/10847774 ## Citation > US National Institutes of Health, RePORTER application 10847774, Clinical Protocol and Data Management (2P30CA138313-16). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10847774. Licensed CC0. --- *[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*