# Protocol Review and Monitoring System

> **NIH NIH P30** · STANFORD UNIVERSITY · 2024 · $42,202

## Abstract

PROJECT SUMMARY
The overall mission of the Protocol Review and Monitoring System (PRMS) is to ensure that Stanford Cancer
Institute (SCI) investigators execute clinical research that is scientifically meritorious, well designed,
distributed across a broad range of cancer disciplines and feasible to conduct. The SCI Scientific Review
Committee (SRC) and the disease or modality-oriented Clinical Research Groups (CRGs) together fulfill the
PRMS responsibilities for cancer-related clinical research at the SCI and within Stanford. The CRGs conduct
the first stage of the selection and prioritization of cancer-related clinical trials, and the SRC conducts the
second stage. With the ultimate authority to approve studies, the SRC ensures all cancer-related clinical trials
conducted at the SCI are of the highest scientific merit, align with the priorities of the SCI and are feasible to
conduct. Over this CCSG cycle, the SRC reviewed an average of 140 new studies each year. The initial SRC
study review determination across the grant period was 61% approved, 24% response required, 13% tabled
and 2% rejected. An average of 116 studies were reviewed annually for scientific progress.
The SRC is responsible for routine scientific progress reviews of studies and has the authority to suspend or
close studies due to low accrual, stopping rule violations, changes in scientific relevance or other scientific-
based or compliance-based rationales.
Major improvements to the PRMS were implemented over this CCSG cycle:
· Oversight of PRMS functions was moved under the newly appointed SCI Deputy Director, Heather
 Wakelee, MD, to enhance separation of PRMS from Clinical Protocol and Data Management which
 reports to the Associate Director for Clinical Research, Mark Pegram, MD.
· A study priority scoring tool was implemented by all CRGs to standardize the first-stage review process,
 elucidate the impact of proposed studies and facilitate trial prioritization in alignment with the SCI Strategic
 Plan and catchment area cancer burden and demographics.
· A systematic method to calculate accrual progress utilizing an accrual index was implemented for a more
 effective evaluation of scientific progress, leading to improved action planning.
· Annual review of all interventional studies opened to accrual for 5 years or longer for continued scientific
relevance.
· Enhanced data and safety monitoring plan review was implemented by the SRC to ensure that the
 management plan was commensurate with the risks of the study

## Key facts

- **NIH application ID:** 10887435
- **Project number:** 5P30CA124435-16
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** Lawrence D Recht
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $42,202
- **Award type:** 5
- **Project period:** 2007-06-04 → 2027-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10887435

## Citation

> US National Institutes of Health, RePORTER application 10887435, Protocol Review and Monitoring System (5P30CA124435-16). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10887435. Licensed CC0.

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