# Clinical Protocol and Data Management (CPDM)

> **NIH NIH P30** · VIRGINIA COMMONWEALTH UNIVERSITY · 2024 · $137,390

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT: PROJECT SUMMARY
Part I: Clinical Protocol and Data Management (CPDM): The Clinical Trials Office (CTO) at Virginia
Commonwealth University (VCU) Massey Cancer Center (MCC) comprises just over 100 employees who
provide centralized clinical research support services to MCC investigators. Services include comprehensive
regulatory support from protocol conception to activation, investigational new drug application support,
registration of new trials, and results reporting with ClinicalTrials.gov. The CTO also optimizes accrual and quality
data collection for externally peer-reviewed, investigator-initiated, National Clinical Trials Network, and industry-
sponsored studies by providing a centralized core of trained clinical research nurses, coordinators, and data
managers. Research coordination and protocol compliance is enhanced through fostering of investigator-patient-
CTO interaction, collaboration, and teamwork. The CTO actively assesses protocol and regulatory compliance
and monitors data accuracy and timeliness. As the central data repository of all oncology, human subjects-
related research studies at VCU, the CTO provides comprehensive reports and performance metrics to the
MCC leadership for proper oversight, strategic planning, and performance improvement. The CTO is
instrumental in the development and delivery of training and education initiatives for both clinical research staff
and investigators. In 2021, the CTO reported recruitment of 1,288 individuals into all clinical or community-based
research studies being conducted under the MCC (473 interventional and 815 non-interventional accruals) and
facilitated the activation of 62 new studies, including 22 institutional and externally peer-reviewed studies.
Part II: Data and Safety Monitoring (DSM): DSM is required for all interventional studies within the MCC. For
investigator-initiated trials, the MCC has established its own DSM Committee (DSMC), which performs risk-
based monitoring to ensure the highest levels of patient safety. Effective quality control functions are also
instituted to ensure the highest level of protocol compliance according to the MCC’s NCI-approved DSM Plan.
In 2021, the DSMC actively monitored 23 studies.
Part III: Inclusion of Women, Minorities, and Across the Lifespan in Clinical Research: The MCC maintains
and supports multiple, proactive efforts to promote the recruitment of women and minorities into research. In
2021, among the 473 interventional accruals, 56% were women, and 43% represented ethnic and/or racial
minorities. The MCC supports the NIH policy on the inclusion of individuals across the lifespan in research. In
2021, 25 children were enrolled onto interventional studies, 258 participants between the ages of 18-64, and 131
participants 65 or older were enrolled onto interventional studies.

## Key facts

- **NIH application ID:** 10850947
- **Project number:** 5P30CA016059-42
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** LESLIE M RANDALL
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $137,390
- **Award type:** 5
- **Project period:** 1995-12-01 → 2028-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10850947

## Citation

> US National Institutes of Health, RePORTER application 10850947, Clinical Protocol and Data Management (CPDM) (5P30CA016059-42). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10850947. Licensed CC0.

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