# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2024 · $738,520

## Abstract

ABSTRACT CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) 
The overall goal of Clinical Protocol and Data Management (CPDM) is to provide high-quality infrastructure 
support for all aspects of clinical protocol research at MD Anderson. The services of the CPDM, directed by Dr. 
Aman Buzdar, Associate Director for Clinical Research Administration, include support of single- and multi- 
center clinical trials through the protocol lifespan; human subject/clinical research education; auditing and 
monitoring active clinical trials; assuring regulatory compliance of IND studies; facilitating protocol financial 
management; and supporting biospecimen research. The CPDM complements the activities of the Protocol 
Review and Monitoring System (PRMS) by supporting the electronic protocol submission and evaluation 
processes. A Protocol Systems Legacy Refresh Project (PSLR) was undertaken in 2016 to migrate functionality 
of the legacy systems to a more contemporary, stable platform. The new electronic health record (EHR) system 
OneConnect (Epic), launched in March 2016, provides an integrated clinical, research, and business platform, 
with 2,188 interventional protocols and 102,134 patients now linked to the EHR. During the last 6 years, the total 
number of protocols managed by CPDM has increased from 5,018 in FY2012 to 5,974 in FY2017 (an increase 
of 19%). New patient registrations to interventional and non-interventional trials have averaged about 35,000 per 
year; however, a significant reduction was noted in the level of FY2016 and FY2017 accruals (24,676 and 26,568, 
respectively), largely due to efforts made to ensure a smooth implementation of OneConnect. Importantly, MD 
Anderson investigators have enrolled 739 patients to the NCI's National Clinical Trial Network (NCTN) protocols 
between March 2014 (year 1 of MD Anderson's Lead Academic Participant Site grant) and February 2017. Lastly, 
from March through August 2018, the Office of Clinical Research Administration underwent a substantive 
evaluation of all departments and functions, resulting in a revised organizational structure and greater emphasis 
on integration and accountability across departments to enhance efficiencies within related processes and 
ensure ongoing performance improvements. 
The goals of the CPDM are achieved through the following Specific Aims: 
Aim 1: Clinical Protocol and Data Management: To provide central management and oversight of all aspects of 
clinical protocol research at MD Anderson. 
Aim 2: Data and Safety Monitoring: To provide centralized resources for data monitoring, verifying data validity 
and integrity, and ensuring the safety of study participants in clinical trials. 
Aim 3: Inclusion of Minorities and Women in Clinical Research: To evaluate, monitor, and enhance the 
recruitment and retention of women and minorities in MD Anderson clinical research. 
Aim 4: Inclusion of Children in Clinical Research: To ensure the inclusion of pediatric oncology pat...

## Key facts

- **NIH application ID:** 10953772
- **Project number:** 4P30CA016672-48
- **Recipient organization:** UNIVERSITY OF TX MD ANDERSON CAN CTR
- **Principal Investigator:** Jennifer Keating Litton
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $738,520
- **Award type:** 4N
- **Project period:** 1996-08-28 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10953772

## Citation

> US National Institutes of Health, RePORTER application 10953772, Clinical Protocol and Data Management (4P30CA016672-48). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10953772. Licensed CC0.

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