# Data Management Core

> **NIH NIH U10** · DANA-FARBER CANCER INST · 2024 · $3,745,731

## Abstract

The Data Management core activities are performed by the Data Management Center of the ECOG- 
ACRIN Statistics and Data Management Center. The Data Management Center is responsible for 
collection and processing of data on ECOG-ACRIN studies and for related information systems 
support. The Center has two components. SDMC-EAMRF at the ECOG-ACRCIN Medical Research 
Foundation has primary responsibility for therapeutic studies. The SDMC-ACR at the American 
College of Radiology has primary responsibility for diagnostic and imaging studies. All clinical data on 
studies activated since the start of the NCTN is collected and managed in Medidata Rave, the NCTN's 
common Clinical Data Management System. ECOG-ACRIN has been a leader in developing 
configuration standards and operational procedures for using Rave in the NCTN. Data review 
procedures are well developed and include clinical review, which is usually performed by study chairs. 
The Data Management core has established extensive education and training programs for site 
personnel and investigators. These training programs are an important part of ensuring timely and 
accurate data submission and review. The data management core has also developed reports for 
monitoring site performance regarding timeliness and accuracy of data submission, and works with the 
ECOG-ACRIN Operations on the annual institution evaluation. 
The Statistics and Data Management Center also fully utilizes standard NCTN tools, such as the 
Oncology Patient Enrollment Network (the web interface for patient enrollment on NCTN studies), the 
Cancer Data Standards Repository library of standardized data elements, the common toxicity criteria 
for adverse events, the CTEP-AERS system for adverse event reporting, which is being integrated into 
Rave), and the Clinical Data Update System for reporting selected trial and patient data to NCI. The 
Information Systems group maintains multiple databases, develops and maintains tools for monitoring, 
reporting, and communication, and has developed infrastructure to support complex trials such as NCI- 
MATCH.

## Key facts

- **NIH application ID:** 10796901
- **Project number:** 5U10CA180794-11
- **Recipient organization:** DANA-FARBER CANCER INST
- **Principal Investigator:** Jean MacDonald
- **Activity code:** U10 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $3,745,731
- **Award type:** 5
- **Project period:** 2014-04-29 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10796901

## Citation

> US National Institutes of Health, RePORTER application 10796901, Data Management Core (5U10CA180794-11). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10796901. Licensed CC0.

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