# Clinical Protocol and Data Management

> **NIH NIH P30** · JOHNS HOPKINS UNIVERSITY · 2021 · $803,960

## Abstract

ABSTRACT
The Clinical Protocol and Data Management (CPDM) is the central home for numerous services to faculty
and staff members conducting research at the Sidney Kimmel Comprehensive Cancer Center (SKCCC). The
CPDM has a key leadership role in the SKCCC infrastructure and, in conjunction with the Associate Director of
Clinical Research, oversees all clinical research conducted in the SKCCC, developing, implementing and
enforcing SKCCC and institutional research standards. The Clinical Research Managers of each Clinical
Research Group (CRG) have a reporting relationship to the CRG Directors and the CPDM Manager,
supporting a centralized infrastructure while bolstering flexibility within each disease group. The CPDM
developed, implemented, and currently oversees and maintains several electronic resources available to the
SKCCC, including CRMS, the centralized repository for all clinical trial data. It led the way in integrating these
systems with existing and developing institutional systems, allowing efficient flow of protocol-related data. The
CPDM provides education and training, which includes cultural competency, CRMS training and individual,
hands-on training for new coordinators and nurses based on CRG needs. The CPDM provides regulatory
expertise regarding FDA regulations and Investigational New Drug (IND) submissions, internal regulatory
oversight and guidance, and protocol development support for all investigator-initiated trials. The CPDM
supports both the Protocol Review and Monitoring System (PRMS) and the Data Safety Monitoring
Committee (DSMC), though this support is administrative in nature, and both committees are independent and
distinct bodies. Quality assurance services are an essential component of the CPDM via auditing, monitoring,
developing and maintaining standard operating procedures. Staff members facilitate eIRB submissions,
provide the final activation for studies, and act as liaisons with the Johns Hopkins Institutional Review Boards,
outside auditors and regulatory agencies. The CPDM also supports and maintains the SKCCC Coordinating
Center, which provides multisite regulatory and data support, site initiation services, and manages all Phase II
trials conducted under the Experimental Therapeutics Clinical Trial Network (ETCTN) grant. The Inclusion of
Women and Minorities in SKCCC clinical trials is a major focus of leadership and faculty members, and
important steps have been taken to advance this effort, including the formation of the SKCCC Office of
Community Cancer Research. This group focuses on external community outreach and the internal evaluation
of SKCCC recruitment and retention practices to improve clinical trial participation. Mandatory cultural
competency training was implemented across the SKCCC to improve awareness among providers and staff
members. The Assistant Director for Diversity and Inclusion works with and is supported by the CPDM to
collect and analyze accrual data, develop SOPs to improve acc...

## Key facts

- **NIH application ID:** 10135901
- **Project number:** 5P30CA006973-58
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Michael A Carducci
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $803,960
- **Award type:** 5
- **Project period:** 1997-05-07 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10135901

## Citation

> US National Institutes of Health, RePORTER application 10135901, Clinical Protocol and Data Management (5P30CA006973-58). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10135901. Licensed CC0.

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