# Clinical Protocol and Data Management

> **NIH NIH P30** · VIRGINIA COMMONWEALTH UNIVERSITY · 2021 · $62,573

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT: PROJECT SUMMARY/ABSTRACT 
Cancer clinical trials are a necessary and important part of the research activities at the Virginia 
Commonwealth University (VCU) Massey Cancer Center (MCC), as they provide the opportunity for cancer 
patients to receive the most promising new therapies and provide the mechanism that brings MCC laboratory 
findings into the clinic. Since its establishment in 1976, the Clinical Trials Office (CTO) has supported clinical 
cancer research at VCU. The CTO provides support for investigator-initiated trials (IITs), cooperative group 
trials as a MU-NCORP site and full member of Alliance, COG, ECOG-ACRIN and NRG Oncology, and 
corporate-sponsored studies, resulting in 184 accruals in 2015. The mission of the CTO is to provide central 
management and oversight for the coordination, facilitation, and support of the development and conduct of all 
oncology clinical research being conducted at the institution and its affiliated sites. 
The 52 CTO FTEs manage a portfolio of 184 clinical trials of which 149 are interventional and 35 non- 
interventional clinical research projects open to accrual, assuring the highest quality of research and 
adherence to relevant regulations by upfront coordination of the study and ongoing review of research 
compliance. The CTO provides 64 MCC clinical investigators support and study data management, as well as 
protocol development, regulatory affairs management, compliance responsibilities, quality assurance, and 
monitoring functions, screening for potential research participants, support of patient recruitment and 
treatment, coordination with pharmacy and other clinical services, record keeping, adverse event reporting, 
information dissemination and liaison with federal and industry sponsors and regulatory bodies. In addition, the 
CTO provides project management and development for MCC IITs, from concept development through 
activation, and ultimately, the reporting of results. 
The CTO provides resource support to the Protocol Review and Monitoring Committee (PRMC), the Data and 
Safety Monitoring Committee (DSMC), and the Cancer Clinical Research Committee (CCRC). The CTO has 
been active in NCI initiatives, to include the Clinical Trial Reporting Program (CTRP). The CTO has a track 
record of leading new endeavors for the research enterprise within VCU, as it supports the largest single 
clinical research group in the institution. The objectives of the CTO are to provide a well-trained, 
compassionate, ethical, and diverse clinical research staff that are supported by an integrated administrative 
organizational structure with efficient workflow processes within MCC, VCU Health, and the VCU Office of 
Research and Innovation. The CTO supports MCC clinical investigators in all aspects of conducting high 
quality clinical research to reduce the burden of cancer in the MCC catchment area, with an emphasis on 
minority and underserved populations.

## Key facts

- **NIH application ID:** 10174766
- **Project number:** 5P30CA016059-40
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** andrew poklepovic
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $62,573
- **Award type:** 5
- **Project period:** 1995-12-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10174766

## Citation

> US National Institutes of Health, RePORTER application 10174766, Clinical Protocol and Data Management (5P30CA016059-40). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10174766. Licensed CC0.

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