# Clinical Protocol and Data Management

> **NIH NIH P30** · WASHINGTON UNIVERSITY · 2021 · $635,122

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT: PROJECT SUMMARY
The mission of the Clinical Trials Core (CTC) is to support SCC members in the development and conduct of
clinical research of the highest quality by providing them with access to an effective, efficient and economical
team specializing exclusively in cancer research. This allows for the coordination of robust investigator-initiated
trials (IIT), innovative industry-sponsored trials, and active participation in cooperative groups and consortia. The
CTC offers comprehensive services in protocol development, scientific review, regulatory submission, study
coordination, data collection, education, training, financial management, and quality assurance. The CTC has
experienced continued growth during the project period, with a staffing increase of 52% (256 staff members
today). This resulted from a corresponding increase in clinical trial accrual. When comparing the five-year
average from the current project period to the previous project period, interventional clinical trial accrual
increased 77% while interventional treatment clinical trial accrual increased 25%. There has also been a 30%
increase in activation of new pediatric clinical trials, a targeted area for growth within the CTC. Project growth
includes a 52% increase in the submission of new IITs managed by Protocol Development across the project
period. The CTC has pursued opportunities to reduce protocol activation timelines across all trial types, utilizing
commercial IRBs to reduce IRB approval time by 38% for industry-sponsored trials and by allowing administrative
scientific review for institutional trials that have already received scientific review committee approval at another
NCI cancer center resulting in a reduction of 14 days. In addition, the CTC employs technology to report key
performance metrics and empower investigators with real-time data related to their projects. In 2015, the CTC
launched the OnCore Clinical Trial Management System (CTMS), which facilitates submission to the PRMS,
serves as a web-based repository for documents that have received regulatory approval, houses an electronic
data capture system for institutional clinical trials readily accessible by investigators and statisticians, and tracks
key metrics including protocol- and accrual-based data regularly utilized in process improvement projects. The
implementation of the OnCore CTMS provided opportunities for enhanced real-time monitoring of clinical trial
accrual for inclusion of minority, rural, and medically underserved patients, and in 2018, SCC’s overall patient
population included 15.5% minority patients but boasted 28.1% minority accrual to interventional trials.

## Key facts

- **NIH application ID:** 10217031
- **Project number:** 5P30CA091842-20
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** TIMOTHY J. EBERLEIN
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $635,122
- **Award type:** 5
- **Project period:** 2001-08-02 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10217031

## Citation

> US National Institutes of Health, RePORTER application 10217031, Clinical Protocol and Data Management (5P30CA091842-20). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10217031. Licensed CC0.

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