# CCSG supplement: Creating an efficient clinical trial build system via the Clinical Trials Rapid Activation Consortium (CTRAC)

> **NIH NIH P30** · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2020 · $496,663

## Abstract

PROJECT SUMMARY
Standard-of-care electronic health records (EHR) treatment plans are constructed once prior to implementation
and support quality through standardization. By comparison, treatment-plan builds for clinical trials may support
as few as zero trial participants, must be built from the ground up for each new trial and at each added site, and
have treatment plans that 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 fully
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:** 10225123
- **Project number:** 3P30CA016672-44S4
- **Recipient organization:** UNIVERSITY OF TX MD ANDERSON CAN CTR
- **Principal Investigator:** PETER W PISTERS
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $496,663
- **Award type:** 3
- **Project period:** 2020-09-01 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10225123

## Citation

> US National Institutes of Health, RePORTER application 10225123, CCSG supplement: Creating an efficient clinical trial build system via the Clinical Trials Rapid Activation Consortium (CTRAC) (3P30CA016672-44S4). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10225123. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*