# Clinical Protocol and Data Management

> **NIH NIH P30** · RESEARCH INST OF FOX CHASE CAN CTR · 2020 · $8,695

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT – PROJECT SUMMARY/ABSTRACT
Clinical Protocol and Data management (CPDM) at Fox Chase Cancer Center (FCCC) is spearheaded by
the Clinical Trials Office (CTO). The CTO provides central management, research support and oversight
functions for the conduct of cancer-related clinical trials for the Cancer Center. CTO services are provided
for all interventional treatment trials conducted within the Cancer Center, including those at FCCC’s Main
Campus, FCCC’s Bone Marrow Transplant Unit and the Temple University Health Science Center. For other
cancer relevant clinical research, the CTO facilitates study submission, ongoing management of study
materials and annual reviews; however, most researchers utilize research staff within their department to
perform the conduct of the study. The CTO has particular responsibility for institutional treatment trials
developed by Cancer Center members. Along with the Quality Assurance (QA) group of the CTO, research
teams are trained to support the conduct of each trial. Studies are audited internally by the QA group to ensure
eligibility and compliance to protocols, as well as appropriate reporting of serious adverse events. They
participate in developing corrective action plans for issues identified by internal or external auditors. They also
facilitate the review of Early Phase Clinical Trials and Investigator-initiated Trials by the FCCC Data Safety
Monitoring Committee. From 2011 to 2014, accrual to Interventional Treatment Trials rose from 358 to 668 (an
87% increase), and to Interventional Investigator-initiated Treatment Trials from 77 to 287 (273% increase).

## Key facts

- **NIH application ID:** 10113014
- **Project number:** 3P30CA006927-54S4
- **Recipient organization:** RESEARCH INST OF FOX CHASE CAN CTR
- **Principal Investigator:** Margaret von Mehren
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $8,695
- **Award type:** 3
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10113014

## Citation

> US National Institutes of Health, RePORTER application 10113014, Clinical Protocol and Data Management (3P30CA006927-54S4). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10113014. Licensed CC0.

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