# Clinical Protocol and Data Management

> **NIH NIH P30** · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · 2021 · $470,949

## Abstract

ABSTRACT – Clinical Protocol and Data Management 
The Central Protocol and Data Monitoring Office (CPDMO) within the St. Jude Comprehensive Cancer Center 
(SJCCC) provides centralized administrative, regulatory, and educational services for clinical trials-related 
activities. It is the coordinating center for protocol standardization, regulatory and compliance guidance, 
administrative submissions, protocol registration data, and monitoring. The CPDMO is integral to the Clinical 
Trials Administration (CTA), which provides comprehensive infrastructure for conducting SJCCC clinical trials. 
Together, the CTA and CPDMO perform the following functions to provide outstanding clinical trials support to 
SJCCC members: (1) Facilitate the development of high-quality clinical trials, within a standardized framework, 
to meet institutional and federal requirements. (2) Maintain a centralized submission process for institutional 
review and approval. (3) Set standards by fostering consistent conduct and compliance through the monitoring 
of all clinical trials. (4) Ensure appropriate participant enrollment via a centralized clinical trials registration 
system. (5) Provide infrastructure and coordinate trials at affiliate and collaborating institutions. (6) Adhere to the 
Data Safety Monitoring Plan, which was revised and approved by the NCI in August 2017. The CPDMO also 
provides administrative support to the Clinical Trials Scientific Review Committee to ensure the thorough 
scientific review of all trials in the SJCCC. Studies are monitored commensurate with the degree of risk to 
participants and the size and complexity of the study. The SJCCC's Data Safety Monitoring Board is composed 
of external experts who independently oversee institutional Phase III trials and high-risk trials; an Internal 
Monitoring Committee assesses findings from individual audit reports and safety trends and recommends 
educational and corrective actions. Trial monitoring and safety reporting is the responsibility of all members of 
the clinical trial process. Particular attention is paid to monitoring investigator-initiated trials (IITs), especially 
those with no external monitoring program. The CPDMO presently includes 42 staff members. Over the current 
funding period, the number of new pediatric patients with cancer increased 11%, from 459 in FY 2013 to 516 in 
FY2017: 60% enrolled into interventional therapeutic trials, and 90% of those were in institutional IITs. Similarly, 
the CPDMO assisted with 5,470 enrollments into interventional (therapeutic and nontherapeutic) trials, a 23% 
increase in accrual into this category, compared to the previous funding period. In addition, we assisted with 
30,071 enrollments into non-interventional clinical trials. During the current funding period, the CPDMO managed 
more than 406 prospective trials, of which 52% are institutional IITs. During FY2017, the CPDMO's portfolio, 
subdivided by sponsor, included 61% IIT/peer reviewed,...

## Key facts

- **NIH application ID:** 10116332
- **Project number:** 5P30CA021765-42
- **Recipient organization:** ST. JUDE CHILDREN'S RESEARCH HOSPITAL
- **Principal Investigator:** Elizabeth Fox
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $470,949
- **Award type:** 5
- **Project period:** 1997-04-01 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10116332

## Citation

> US National Institutes of Health, RePORTER application 10116332, Clinical Protocol and Data Management (5P30CA021765-42). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10116332. Licensed CC0.

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