# Creating An Efficient Clinical Trial Build System via The Clinical Trials Rapid Activation Consortium (CTRAC)

> **NIH NIH P30** · UNIVERSITY OF WISCONSIN-MADISON · 2020 · $300,161

## Abstract

PROJECT SUMMARY
Standard-of-care electronic health records (EHR)-based treatment plans support efficiency and quality
through standardization. However, treatment-plan builds for clinical trials, irrespective of the number of
patients, must be built from the ground up for each new trial and at each added site. Additionally,
investigational treatment plans often require configurations for novel medications, numerous ancillary
procedures, and research finance requirements. The current paradigm is costly, complex, and
inefficient. Representatives of five cancer centers agreed to be part of the project’s Clinical Trials Rapid
Activation Consortium (CTRAC). The project’s goal is to develop processes across multiple NCI-supported
cancer centers that will facilitate the development of single builds of EHR clinical-trial treatment plans that
can be deployed at multiple institutions in support of NCI- sponsored network studies. Members will
investigate the question: can a small consortium of clinical trials sites develop methods to standardize
workflows, drug formularies, drug administration procedures, and laboratory requirements leading to the
creation of the components for a standardized, electronic, clinical trials build system? Specific aims are as
follows: 1) To identify the tasks currently performed by EHR investigational treatment plans (SOPs, policies,
and workflows) and to define differences among these SOPs at the individual member sites of the
consortium; 2) To standardize the processes within each task where possible and document differences that
would require modifications across sites; 3) To develop a master assessment of EHR treatment-plan
modules that could be reused to perform components of the same research protocol tasks at multiple sites
while maintaining compliance with the requirements of member organizations of the consortium; 4) To
organize a leadership structure for the consortium that will work with the NCI and an EHR provider to
oversee this initiative to assure that adequate progress is made toward the ultimate goal of creating a more
automated electronic clinical-trial build system that will facilitate the activation of clinical trials across all NCI-
supported networks; 5) To build standardized electronic clinical-trial build modules that could undergo future
pilot testing at each institution for a specified group of NCI-sponsored clinical trials; and 6) To facilitate
development of metrics for the new EHR processes that can demonstrate whether more consistent patient
care, reduced medication errors, and fewer adverse events result from a standardized approach to clinical-
trial build modules.

## Key facts

- **NIH application ID:** 10227524
- **Project number:** 3P30CA014520-46S3
- **Recipient organization:** UNIVERSITY OF WISCONSIN-MADISON
- **Principal Investigator:** HOWARD H. BAILEY
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $300,161
- **Award type:** 3
- **Project period:** 2020-09-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10227524

## Citation

> US National Institutes of Health, RePORTER application 10227524, Creating An Efficient Clinical Trial Build System via The Clinical Trials Rapid Activation Consortium (CTRAC) (3P30CA014520-46S3). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10227524. Licensed CC0.

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