# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF ARIZONA · 2020 · $451,097

## Abstract

Project Summary / Abstract: Clinical Protocol and Data Management (CPDM) 
The Clinical Trials Office (CTO) at the University of Arizona Cancer Center (UACC) is the operational 
equivalent of the CPDM. It provides a centralized and comprehensive infrastructure for the conduct of clinical 
trials involving cancer patients. The CTO oversees institutional, externally peer-reviewed, National Clinical 
Trials Network (NCTN), and industry-sponsored studies. While treatment interventional trials are of major 
interest to the Cancer Center, the CTO also assists in the execution of trials with a broad range of other 
objectives, including diagnostics, cancer screening, basic science, health services, cancer prevention, and 
supportive care. The research supported by the CTO serves both adult and pediatric populations. The UACC 
has invested substantial support in the CTO to enable the management of important interventional trials, their 
associated accruals, and the increasing complexity of clinical trials. The CTO functions as a central 
administrative office for the implementation and conduct of internally and externally funded adult and pediatric 
oncology studies. Review and approval of protocols is performed by the Disease-Oriented Teams (DOTs) or 
Multidisciplinary Teams (MDTs), and the Scientific Review Committee and is required of UACC investigations 
prior to activation. There are nine designated DOTs and four that evaluate new protocols and monitor accrual 
for ongoing studies. The CTO also maintains and assures the quality of data regarding cancer clinical trial 
activation and accrual throughout the University. The CTO is led by well-qualified leadership and is subdivided 
into four major research support groups: 1) Review Committee and Regulatory Support Management; 2) 
Clinical Research Finance and Administrative Management; 3) Clinical Research, Data, and Biospecimen 
Management; and 4) Research Compliance / Quality Management. Clinical research support staff are 
positioned to effectively manage all processes of the trial lifecycle, and the CTO is organized in a manner that 
facilitates continuous improvement. The CTO has defined timelines for study activation that are important to 
maintain efficiency and effectiveness in conducting clinical research. The CTO maintains standard operating 
procedures (SOPs) and workflows that describe work processes conducted by the staff. The CTO facilitates 
the adoption of technology to increase operational efficiencies and quality management practices for 
supporting clinical research. The SOPs of the CTO stipulate that the CTO will conduct regularly scheduled 
internal reviews of protocol records. Since the last review period, the CTO expanded its capacity significantly to 
more appropriately oversee the trials currently open, and in preparation for a significant expansion of new 
faculty recruitment, the Phase I Program, and the community-based network of affiliate organizations. The 
UACC CTO adheres...

## Key facts

- **NIH application ID:** 9969502
- **Project number:** 5P30CA023074-40
- **Recipient organization:** UNIVERSITY OF ARIZONA
- **Principal Investigator:** Rachna Shroff
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $451,097
- **Award type:** 5
- **Project period:** — → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9969502

## Citation

> US National Institutes of Health, RePORTER application 9969502, Clinical Protocol and Data Management (5P30CA023074-40). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9969502. Licensed CC0.

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