# Clinical Protocol and Data Management

> **NIH NIH P30** · ROSWELL PARK CANCER INSTITUTE CORP · 2024 · $511,757

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT
ABSTRACT
The goal of Clinical Protocol and Data Management (CPDM) at Roswell Park is to assist investigators in the
development, implementation, conduct, completion, and reporting of clinical trials in a scientifically rigorous and
regulatory compliant manner. This goal is carried out by Clinical Research Services (CRS), a centralized
resource that oversees a broad portfolio of clinical trials, including institutional trials (e.g., investigator-initiated
trials or IITs), trials in association with national clinical trial networks (LAPS/NCTN), other National Cancer
Institute (NCI)-sponsored trials (ETCTN, CITN, EDDOP, COG), I-SPY Network and industry-sponsored trials.
CPDM staff assist investigators in assembling clinical and scientific content for protocols, developing budgets,
and facilitating timely initiation and completion of trial activities such as effective protocol reviews and
implementation. Training and educational materials are provided to all faculty and staff engaged in clinical trial
activities. CPDM oversight of clinical research extends to submission of the protocol, development of
amendments, and continuing reviews in conjunction with the Scientific Review Committee (SRC) and Institutional
Review Board (IRB), quality assurance, and management and tracking of all regulatory documents. CPDM staff
provide critical administrative support to the Clinical Disease Teams (CDTs) for protocol prioritization and
assessments of ongoing scientific relevance, and for interactions with the SRC (see Protocol Review and
Monitoring System) and Data and Safety Monitoring Committee (DSMC).
The work of CPDM is organized around four specific aims:
1. Provide central infrastructure foundational to collaboration and productivity, including a clinical
 trial management system and technical staff to support Roswell Park investigators in their efforts to
 promote efficient and effective clinical trial development, timely activation, and outcome reporting.
2. Ensure excellence in clinical research performance through training and education in accordance
 with the highest standards of conduct, applicable regulations, policies, and procedures.
3. Deliver appropriate oversight and monitoring of all cancer-related Roswell Park clinical trials, thus
 ensuring participant safety, data integrity, and the quality and reproducibility of the findings.
4. Coordinate and cultivate multi-investigator, transdisciplinary, and multi-institutional partnerships
 to promote and facilitate access to and implementation of clinical trials within the Roswell Park catchment
 area, State of New York, and beyond.

## Key facts

- **NIH application ID:** 10848676
- **Project number:** 2P30CA016056-47
- **Recipient organization:** ROSWELL PARK CANCER INSTITUTE CORP
- **Principal Investigator:** Igor Puzanov
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $511,757
- **Award type:** 2
- **Project period:** 1997-06-16 → 2029-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10848676

## Citation

> US National Institutes of Health, RePORTER application 10848676, Clinical Protocol and Data Management (2P30CA016056-47). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10848676. Licensed CC0.

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