# Clinical Protocol and Data Management

> **NIH NIH P30** · ROSWELL PARK CANCER INSTITUTE CORP · 2021 · $336,019

## Abstract

The overall goal of the Clinical Protocol and Data Management (CPDM) resource 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 the Clinical Research 
Services, a centralized resource that oversees a broad portfolio of clinical trials, including institutional trials 
(investigator-initiated or IIT), national clinical trial network, other NCI-sponsored trials, and industry-sponsored 
trials. CRS provides infrastructure for all clinical research activities. 
 CPDM staff assist investigators in assembling clinical and scientific content of protocols and developing 
budgets, as well as facilitating timely and effective protocol review and implementation. CPDM oversight of 
clinical research studies includes submission of the protocol, amendments, and continuing reviews to the 
Scientific Review Committee and the Institutional Review Board, and the management and tracking of all 
regulatory documents. CPDM staff provides administrative support to the Clinical Disease Teams for protocol 
prioritization and ongoing scientific relevance and the Data Safety Monitoring Committee. CPDM staff assist 
investigators in documentation of adverse events, outcomes, informed consent, accrual, and data items critical 
for safeguarding human subjects. CPDM ensures complete and accurate study data by entering the data in a 
centralized electronic research database. CPDM ensures that all adverse events and their attributions are 
reported promptly and accurately to the required internal and external regulatory agencies, and provides study 
sponsors and regulatory agencies with all required study documents. 
The CPDM has four specific aims: 
 1. Provide a central infrastructure 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, activation, and outcome reporting. 
 2. Ensure clinical research performance in accordance with applicable regulations, policies, and 
 procedures by providing training, and education. 
 3. Provide appropriate oversight and monitoring of all cancer-related Roswell Park clinical trials, 
 ensuring participant safety, validity and integrity of the data collected, and quality control. 
 4. Coordinate and cultivate partnerships to promote and facilitate access and implementation of clinical 
 trials within the Roswell Park catchment area, state of New York, and beyond.

## Key facts

- **NIH application ID:** 10148670
- **Project number:** 5P30CA016056-44
- **Recipient organization:** ROSWELL PARK CANCER INSTITUTE CORP
- **Principal Investigator:** Igor Puzanov
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $336,019
- **Award type:** 5
- **Project period:** 1997-06-16 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10148670

## Citation

> US National Institutes of Health, RePORTER application 10148670, Clinical Protocol and Data Management (5P30CA016056-44). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10148670. Licensed CC0.

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