# Clinical Protocol and Data Management (CPDM)

> **NIH NIH P30** · DARTMOUTH COLLEGE · 2020 · $243,594

## Abstract

Project Summary/Abstract: Clinical Protocol and Data Management
The Office of Clinical Research (OCR) is the established office within the Norris Cotton Cancer Center (NCCC)
which supports clinical cancer research at Dartmouth. The OCR provides support for investigator-initiated trials
(IIT), cooperative group trials (as an NCTN Lead Academic Participating Site [LAPS], NCI ETCTN, and Full
Member of Alliance, NRG, and ECOG-ACRIN), and corporate-sponsored studies. The OCR is a service group
within NCCC to provide investigators centralized support and study data management, as well as protocol
development, support for monitoring for cooperative group studies, screening for potential research
participants, and liaison with federal and industry sponsors and regulatory bodies. The OCR provides resource
support to the NCCC clinical protocol scientific review committee (known locally as the Clinical Cancer Review
Committee [CCRC]), the Quality Improvement Committee, the Clinical Trial Investigational Order Set
Committee (CTIOSC), and the Data Safety Monitoring and Accrual Committee (DSMAC). The OCR has been
active in NCI initiatives, such as the Clinical Trial Reporting Program’s (CTRP) centralized data table 4, as well
as overseeing the successful re-application of NCCC as an NCTN LAPS. The OCR has a track record of
piloting new endeavors for the research enterprise within the Dartmouth-Hitchcock Health system, as it
supports the largest single research group in the parent organization. Over the last four years a total of 2,392
adult subjects and 129 pediatric subjects were enrolled in cancer research trials at Dartmouth; 1,432 adult
subjects in interventional trials, and 687 adult subjects in non-interventional trials. During the twelve-month
reporting period, a total of 758 patients were accrued to NCCC clinical trials. This includes 608 patients
accrued at NCCC and 150 patients accrued to NCCC investigator-initiated trials open at other institutions. The
adult subject enrollment included 61% (371) women, which percentage-wise is higher than the catchment area
female cancer population of 53% (female n=6,326 out of 11,984 cancer patients). With regard to data safety,
DSMAC is a chartered multidisciplinary committee charged with overseeing monitoring of participant safety,
conduct and progress of research protocols, and the validity and integrity of clinical trials data at NCCC and its
subsites that are not reviewed by another study-specific safety and data monitoring committee. DSMAC has
the authority to require protocol amendments required for participants’ safety, suspend study enrollment and
study activities, or recommend study closure to NCCC’s CCRC. For specific protocols, independent internal
monitoring assesses PI and team qualifications, as well as OCR regulatory, data integrity, and pharmacy
compliance. The DSMAC and the IRB have the authority to suspend immediately accrual and protocol
activities until concerns related to the adverse events a...

## Key facts

- **NIH application ID:** 9855319
- **Project number:** 2P30CA023108-41
- **Recipient organization:** DARTMOUTH COLLEGE
- **Principal Investigator:** Konstantin H. Dragnev
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $243,594
- **Award type:** 2
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9855319

## Citation

> US National Institutes of Health, RePORTER application 9855319, Clinical Protocol and Data Management (CPDM) (2P30CA023108-41). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9855319. Licensed CC0.

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