# Clinical Protocol and Data Management

> **NIH NIH P30** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2024 · $791,885

## Abstract

CCSG COMPONENT 003 – CLINICAL PROTOCOL AND DATA MANAGEMENT
PROJECT SUMMARY/ABSTRACT
The Vanderbilt-Ingram Cancer Center (VICC) Clinical and Protocol Data Management team (CPDM), known
internally as the VICC Clinical Trials Office (CTO), provides investigators conducting translational and clinical
investigators with the infrastructure necessary to conduct scientifically meritorious research on a local and
national level. CPDM services are available to all Vanderbilt investigators conducting cancer-relevant trials. The
CTO is operationally organized by Disease Team (DT) and provides regulatory and data management services,
research nursing support, as well as contract and budget negotiation, quality assurance, data and safety
monitoring and multi-center investigator-initiated trial (IIT) development programs. VICC places the highest
priority on the safety of patients participating in research trials and continually strives to foster and maintain the
highest level of oversight and compliance across the clinical and research enterprise. As a result of this long-
standing commitment to research excellence, every interventional trial conducted at VICC must include a plan
for data and safety monitoring. The NCI-approved VICC Data and Safety Monitoring Plan (DSMP), was revised
and approved by the NCI in 2019. The plan outlines that while each PI is responsible for day to day oversight of
their protocol, the initial scientific review conducted by the VICC SRC includes the assignment of a more detailed,
protocol-specific plan for DSMC oversight based on the DSMP. Per the plan, the DSMC is independent of the
SRC and has the right to modify the SRC recommendations within the parameters of the DSMP. Since the last
reporting period, the CTO has made continuous process improvements and expansions within several service
lines to adapt to the increasing complexity of cancer trials while developing new workflows to capitalize on
opportunities provided by the Epic transition. The results of these changes are anticipated to reduce trial opening
times and improve ability of investigators to meet accrual goals moving forward. During the project period, the
total number of protocols managed by the CTO has increased by 27%. Among the trials conducted at VICC in
CY18, 118 of the 452 (26%) protocols open to accrual were were initiated or significantly influenced by VICC
investigators, even when sponsored by industry partners. Importantly, VICC investigators have enrolled 492
patients to National Group studies during the project period. VICC is committed to providing or supporting
excellent care and access to trials for the catchment area and ensuring the appropriate representation of women,
minorities and children as well as offer the mix of trial targeting underserved populations in the catchment area
including Blacks and Latinos and socioeconomically disadvantaged populations. The CTO will continue to
respond to and support the needs of its investigators by adapting its...

## Key facts

- **NIH application ID:** 10900673
- **Project number:** 5P30CA068485-29
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** Elizabeth J Davis
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $791,885
- **Award type:** 5
- **Project period:** 1998-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10900673

## Citation

> US National Institutes of Health, RePORTER application 10900673, Clinical Protocol and Data Management (5P30CA068485-29). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10900673. Licensed CC0.

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