# Clinical Protocol and Data Management (Core 012)

> **NIH NIH P30** · WAYNE STATE UNIVERSITY · 2020 · $552,343

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT: ABSTRACT 
Part I: Clinical Protocol and Data Management (CPDM): The Clinical Trials Office (CTO) serves as a 
centralized resource providing CPDM services and support to the Cancer Center with the highest priority being 
the safety of participating patients. The CTO provides comprehensive regulatory support from protocol 
conception to activation, including liaison and communication with the IRB of record and sponsors to facilitate 
timely initiation and completion of clinical trial activities, all approval and review processes with the IRB, IND 
support, registration of new trials with NCI CTRP and appropriate registration and results reporting with 
ClinicalTrials.gov. CPDM services facilitate and optimize accrual by providing centralized and trained data 
management and research nurse support to KCI physicians and clinical support staff. Research coordination 
and protocol compliance is enhanced through fostering of physician-patient-CTO interaction, collaboration and 
teamwork. The CTO interfaces with several Institutional Cores (Shared Resources) to facilitate and enhance 
collaboration, improve processes and ensure efficient and effective use of resources. The Clinical Trial 
Management System OnCore® is utilized to administer all clinical trial requirements. CTO supports National 
Clinical Trials Network, NCI-funded peer reviewed, investigator-initiated, and industry sponsored protocols. 
KCI/WSU is a Lead Academic Participating Site under the NCTN (U10 CA180835). Over 100 FTEs provide 
CPDM services as members of the CTO in support of approximately 360 active protocols. 
Part II: Data and Safety Monitoring (DSM): DSM is required for all types of clinical protocols; monitoring is 
commensurate with risk and the DSM functions are distinct from the PRMS oversight and responsibilities. 
Effective quality control and training is provided by the CTO to ensure compliance to the Data and Safety 
Monitoring Plan (DSMP). This includes coordination and administrative support to the Feasibility Review and 
Operations Committee (FROC), Protocol Review and Monitoring Committee (PRMC), the Data and Safety 
Monitoring Committee (DSMC) and the Quality Assurance Committee (QAC). 
Part III: Inclusion of Women and Minorities: KCI maintains and supports multiple, proactive efforts to 
promote the recruitment of women and minorities. These efforts have resulted in exceptional enrollment of 
minorities and women to interventional trials over the current grant period with 40.2% accrual of minorities and 
61.4% accrual of women in 2013. 
Part IV: Inclusion of Children: KCI partners with Children's Hospital of Michigan to facilitate pediatric 
accrual to clinical trials; supporting the NIH policy and guidelines on the inclusion of children in research.

## Key facts

- **NIH application ID:** 9836640
- **Project number:** 5P30CA022453-38
- **Recipient organization:** WAYNE STATE UNIVERSITY
- **Principal Investigator:** LAWRENCE E FLAHERTY
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $552,343
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9836640

## Citation

> US National Institutes of Health, RePORTER application 9836640, Clinical Protocol and Data Management (Core 012) (5P30CA022453-38). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9836640. Licensed CC0.

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