# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2020 · $356,539

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) 
ABSTRACT 
The Clinical Protocol and Data Management (CPDM) of the University of Alabama at Birmingham (UAB) 
Comprehensive Cancer Center (CCC) is charged with maintaining the highest standards of clinical 
investigation that are aligned with all UAB, state and federal regulations, while assisting investigators in 
protocol development and maintaining efficient processes related to clinical investigations. The CPDM is 
responsible for the following significant functions: 1) Coordination, tracking, and reporting of all cancer clinical 
research activity undertaken at UAB, 2) Continuous improvement of the clinical trial activation process, 3) 
Ongoing education and training of clinicians and clinical research staff, 4) Clinical trial data quality monitoring, 
5) Cancer clinical trial participant safety, and 6) Actively ensuring all sections of the population represented in 
the UAB CCC's catchment area have the opportunity to be represented in cancer clinical trials. CPDM adds 
value to the work of the UAB CCC members by providing support for protocol development as well as 
navigating the PRMS approval process, and assuring that there is knowledgeable and professional support for 
investigators at all stages of experience with the clinical trials process. The CPDM accomplishes this objective 
by providing centralized critical staff and infrastructure for all aspects of clinical research coordination and 
activation, as well as the efficient, and ethical conduct of open protocols. It provides the monitoring of the 
studies and all aspects of quality assurance. In addition, the CPDM provides a centralized database of 
protocol-specific data. This robust organization assures that all clinical trials have excellent support in protocol 
adherence, regulatory compliance, and recruitment (especially minority recruitment). Outstanding clinical trial 
support and quality of the CPDM are demonstrated by a number of objective measures described below; four 
FDA audits over the last 15 years (3 for high enrollment in FDA pivotal clinical trials and 1 for a gene therapy 
trial) resulted with no 483 forms being issued. Patient enrollment has increased over the last three years, 
especially to investigator-initiated and early phase clinical trials. The CPDM has taken steps to modify the staff 
and improve the infrastructure in response to the changes in UAB CCC research emphasis and faculty, and to 
the changing regulatory environment over the past five years: 1. The CPDM has relocated to the newly 
renovated Wallace Tumor Institute; 2. The CPDM has implemented OnCore®, a comprehensive clinical trials 
management system; 3. The CPDM has implemented the Clinical Trials Monitoring Committee (CTMC); this 
committee monitors in real time active clinical trials in the UAB CCC for patient safety; 4. The CPDM has 
incorporated specialized protocol management teams who have enhanced both investigator-coordinator 
interaction ...

## Key facts

- **NIH application ID:** 9895656
- **Project number:** 5P30CA013148-48
- **Recipient organization:** UNIVERSITY OF ALABAMA AT BIRMINGHAM
- **Principal Investigator:** Luciano J. Costa
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $356,539
- **Award type:** 5
- **Project period:** — → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9895656

## Citation

> US National Institutes of Health, RePORTER application 9895656, Clinical Protocol and Data Management (5P30CA013148-48). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9895656. Licensed CC0.

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