# Clinical Protocol and Data Management

> **NIH NIH P30** · THOMAS JEFFERSON UNIVERSITY · 2020 · $181,876

## Abstract

CPDM Project Summary 
The Clinical Protocol and Data Management (CPDM) functions are provided by the Clinical Research 
Organization (CRO) of the Sidney Kimmel Cancer Center (SKCC). The CRO provides a centralized office for 
the conduct of cancer clinical research at Thomas Jefferson University (TJU). The purpose of the CRO is to 
provide an effective and efficient infrastructure to support SKCC investigators in developing, implementing, and 
reporting on all cancer clinical research studies at TJU. Comprised of 81 FTEs, the CRO is organized into 
three offices and two support units: Early Drug Development Office, Clinical Trials Office, Multisite Office, 
Protocol Support Unit, and the Quality Assurance and Process Improvement Unit. In 2016, the CRO ensured 
the effective and efficient management of all actively accruing studies (172), which resulted in 785 patient 
accruals, of which 736 were interventional and 49 non-interventional. Main goals of the CPDM are to: 1) 
Support clinical investigators in timely activation and administration of clinical trials; 2) Evaluate compliance 
and safety; and 3) Provide training and education in conducting clinical research. 
 In addition to the CPDM, the SKCC clinical research infrastructure also includes the Data Safety 
Monitoring Committee (DSMC). The DSMC ensures that all SKCC investigator-initiated, interventional studies 
are responsibly managed, appropriately reported, and that they protect the rights and welfare of human 
participants. The purview of this Committee includes ensuring regulatory and protocol compliance, tracking 
protocol-specific early stopping rules, approving dose escalations/expansions, and reviewing adverse events. 
In 2016, the DSMC was responsible for monitoring 51 interventional investigator-initiated trials. 
 The SKCC places a high priority in ensuring that women and racial and ethnic minorities have full 
access to clinical trials. Through the CPDM and DSMC mechanisms, the SKCC has implemented strategic 
efforts to maximize accrual from these populations. In 2016, 45% of the patients enrolled onto interventional 
treatment trials were women (as compared to 37% in 2011) and 42% on intervention non-treatment trials (as 
compared to 31% in 2011). As of submission date in 2017, the percentage of women on all trials has risen to 
49%. In addition, 26% of the 2016 enrollments to interventional treatment trials were minority patients; as such 
the current percentage of minorities on clinical trials is proportional to minorities in the SKCC clinical patient 
population.

## Key facts

- **NIH application ID:** 9957007
- **Project number:** 5P30CA056036-21
- **Recipient organization:** THOMAS JEFFERSON UNIVERSITY
- **Principal Investigator:** SYLVIA ONEILL
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $181,876
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9957007

## Citation

> US National Institutes of Health, RePORTER application 9957007, Clinical Protocol and Data Management (5P30CA056036-21). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9957007. Licensed CC0.

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