# Clinical, Protocol and Data Management

> **NIH NIH P30** · BAYLOR COLLEGE OF MEDICINE · 2021 · $292,343

## Abstract

CPDM PROJECT SUMMARY
The Clinical Protocol and Data Management component of the Dan L Duncan Comprehensive Cancer Center
(DLDCCC) includes the Clinical Trials Support Unit (CTSU) and the Data Review and Safety Monitoring
Committees. The CTSU provides central management, research support, and oversight functions for the conduct
of cancer-related clinical trials at all ambulatory care centers and hospitals that are part of the DLDCCC. CTSU
services are available to all members of the DLDCCC engaged in clinical research. The major functions of the
CTSU are to provide:
1. Assistance with regulatory and administrative matters relating to clinical research and trials, including IRB
 compliance and approval, ongoing amendments and renewal, external agency compliance (such as the
 FDA), and maintenance of regulatory files,
2. Clinical trials informatics expertise, in particular maintaining an electronic database of cancer-related clinical
 protocols, patient registry and clinical data, and monitoring and reporting on accrual,
3. Quality Assurance/Quality Control auditing and personnel training to ensure that the research team is trained
 in best practices in clinical research, and
4. Research nursing/clinical trials management. In the most recent year 01/01/2018–12/31/2018, the CTSU
 supported 224 interventional trials including 54 investigator-initiated studies, 30 of which are conducted under
 IND and 3 under an IDE.
The Data Review and Safety Monitoring Committees are separate from the operational aspect of clinical trials
managed by the CTSU and function to ensure the safety of participants, the validity of data, and the appropriate
termination of studies in the event that undue risks have been uncovered, or it appears that trials cannot be
conducted successfully. The DLDCCC patient safety officer ensures that all data monitoring for Cancer Center
trials is conducted in accordance with the approved monitoring plan.
The CPDM also monitors accrual to ensure there is appropriate representation of women, minorities, children,
and older adults in clinical research.

## Key facts

- **NIH application ID:** 10239137
- **Project number:** 5P30CA125123-15
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** HELEN E HESLOP
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $292,343
- **Award type:** 5
- **Project period:** 2007-07-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10239137

## Citation

> US National Institutes of Health, RePORTER application 10239137, Clinical, Protocol and Data Management (5P30CA125123-15). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10239137. Licensed CC0.

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