# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF IOWA · 2020 · $391,491

## Abstract

Clinical Protocol and Data Management efforts are managed through Clinical Research Services (CRS) of the 
Holden Comprehensive Cancer Center (HCCC) through two related components - The Clinical Trials Support 
Office (CTSO) and Data and Safety Monitoring (DSM). These components are critical shared resources that 
support clinical cancer research including treatment, non-treatment interventional and non-interventional 
studies conducted by members of the HCCC. They encompass clinical research, regulatory, and data and 
safety monitoring. This includes investigator initiated trials, NCTN trials, consortium trials, and industry 
sponsored trials. Services provided by the CTSO related to protocol management include protocol 
development, protocol routing, protocol IRB renewal, modification and adverse event monitoring. The CTSO 
also provides trial specific support through staff members 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. DSM is coordinated through a Data 
and Safety Monitoring Committee.

## Key facts

- **NIH application ID:** 9914260
- **Project number:** 5P30CA086862-20
- **Recipient organization:** UNIVERSITY OF IOWA
- **Principal Investigator:** Douglas Laux
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $391,491
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9914260

## Citation

> US National Institutes of Health, RePORTER application 9914260, Clinical Protocol and Data Management (5P30CA086862-20). Retrieved via AI Analytics 2026-06-14 from https://api.ai-analytics.org/grant/nih/9914260. Licensed CC0.

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