# Core 017 (502) Protocol Review and Monitoring System

> **NIH NIH P30** · H. LEE MOFFITT CANCER CTR & RES INST · 2020 · $4,498

## Abstract

PROJECT SUMMARY 
The MCC Protocol Review & Monitoring System (PRMS) provides internal oversight of the scientific aspects of 
all clinical trials. This includes full authority for opening, closing, and determining appropriate prioritization of all 
studies. To conduct PRMS processes, MCC utilizes four Scientific Review Committees (SRCs) supported by 
staff coordinators. The PRMS has processed more than 500 protocols for initial review over the past three 
years. The average time from submission to full board review is approximately 20 days. Committee 
coordinators review the materials submitted for completeness and work with the study team to acquire any 
additional information needed for the scientific review process. Upon review of the complete information 
package (protocol, investigational brochure, and surveys), the coordinator evaluates the protocol to determine 
if it qualifies for expedited review or requires a full SRC board review. If the coordinator believes the study 
qualifies for expedited review (e.g., NCI, NCTN, or ETCTN), the coordinator routes the study for confirmation 
and approval. If the study requires a full board review, the coordinator will schedule the study on the next 
available open agenda. The four SRCs have meetings scheduled throughout the month to ensure a timely 
review. The PRMS also reviews all amendments to studies. Amendments that change study objectives, 
outcome measures or the study population, and other major changes are sent to full SRC board for review. 
The PRMS processed over 500 amendments to studies in FY15 with 100 requiring a full SRC board review. 
The PRMS is also responsible for monitoring the scientific progress of all MCC studies. Studies are monitored 
at each six-month anniversary of their activation date. Those studies that significantly fall below their 
anticipated accrual rate are flagged for discussion at the full SRC board. At that time, the board reviews the 
progress of the study and also the explanation and corrective action plan from the PI to determine if the study 
is likely to meet its accrual goal. If the SRC determines the study will not meet the accrual goal or is no longer 
scientifically important, then the study is closed by the SRC. 
The specific aims of the PRMS are as follows: 
• Aim 1: Establish and maintain a review committee of sufficient size and breadth of expertise to conduct a 
 critical and fair scientific review of cancer-related research protocols involving human subjects 
• Aim 2: Conduct a thorough scientific review of all cancer-related clinical protocols conducted at the MCC 
 based on specific, pre-determined review criteria 
• Aim 3: Prioritize all MCC clinical trials 
• Aim 4: Monitor scientific progress for ongoing clinical trials

## Key facts

- **NIH application ID:** 10230159
- **Project number:** 3P30CA076292-22S3
- **Recipient organization:** H. LEE MOFFITT CANCER CTR & RES INST
- **Principal Investigator:** Cheryl Byers
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $4,498
- **Award type:** 3
- **Project period:** 1998-02-18 → 2022-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10230159

## Citation

> US National Institutes of Health, RePORTER application 10230159, Core 017 (502) Protocol Review and Monitoring System (3P30CA076292-22S3). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10230159. Licensed CC0.

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