# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF IOWA · 2021 · $257,712

## Abstract

CPDM PROJECT SUMMARY/ABSTRACT
The Clinical Protocol and Data Management (CPDM) efforts of the Holden Comprehensive Cancer Center
(HCCC) are managed through two related components – Clinical Research Services (CRS) and Data and
Safety Monitoring (DSM). These components have grown and strengthened significantly over the prior funding
period. They are critical to the mission of the HCCC and support HCCC clinical cancer research including
treatment, non-treatment interventional and non-interventional studies. They encompass clinical research,
regulatory, and data and safety monitoring. This includes investigator-initiated trials (IITs), National Clinical
Trials Network (NCTN) trials, consortium trials, and industry sponsored trials. Services provided by the CRS
related to protocol management include protocol selection, development, routing, modification and adverse
event monitoring. The CRS also provides trial specific support through staff that assist in assignment of trials to
teams, protocol listing and promotion, accrual tracking, assistance with screening and consenting subjects,
data management, quality assurance, and education for early career clinical investigators. The CRS works
closely with other shared research resources to support translational cancer research, particularly Biostatistics
(Biostats) and the Biospecimens Procurement and Molecular Epidemiology Resource (BioMER). A new
component of the CRS is the Radiology Core Lab (RCL) that provides quantitative imaging services for clinical
trials. DSM is coordinated through HCCC's DSM Committee. The DSM has a distinct function from the
Protocol Review and Monitoring Committee and IRB. DSM focuses on IITs and ensures the development of an
acceptable data and safety monitoring plan, assesses subject safety, monitors clinical trial data veracity and
protocol adherence, and provides education to investigators. CPDM also solicits feedback and responds to that
feedback by providing innovative infrastructure that meets the needs of clinical investigators.

## Key facts

- **NIH application ID:** 10169601
- **Project number:** 2P30CA086862-21
- **Recipient organization:** UNIVERSITY OF IOWA
- **Principal Investigator:** Douglas Laux
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $257,712
- **Award type:** 2
- **Project period:** 2000-07-14 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10169601

## Citation

> US National Institutes of Health, RePORTER application 10169601, Clinical Protocol and Data Management (2P30CA086862-21). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10169601. Licensed CC0.

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