Cancer Institute A national cancer institute
designated cancer center

Protocol Review & Monitoring System

Table of Contents

Cancer Center Protocol Review and Monitoring System (PRMS)

The Purpose of the PRMS is to review the scientific merit, priorities, and progress of all clinical protocols involving cancer patients at Stanford University. The PRMS is responsible for periodic review of scientific progress, the goals of the study and adequate study accruals, but not auditing or data and safety monitoring, which are the responsibility of the Cancer Center Data and Safety Monitoring Committee.

At the Stanford Cancer Center there are two committees involved in the PRMS process. The Cancer Center Scientific Review Committee (SRC) which meets twice per month and the Cancer Center Data and Safety Monitoring Committee (DSMC) which meets once a month.

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Scientific Review Committee (SRC)

The SRC is charged with providing peer review of local and national research protocols involving cancer patients treated at Stanford University Clinical Cancer Center and Lucile Packard Children's Hospital. Scientific review applies to all phases of clinical therapeutic intervention, behavioral clinical trials, tissue and body fluid research, and diagnostic trials, which impact medical decision making for the treatment of cancer patients. The primary focus of scientific review is on the scientific merit of the study.

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Protocol Submission to SRC

To submit a protocol to the Scientific Review Committee, please follow the procedures in the Summary of Steps for Protocol Submission.

If you are the Stanford author(s) of a protocol that will be administered only at Stanford, the SRC requires that you use the following template and guidelines for your protocol document.
Investigator Initiated Clinical Trials Protocol Document Template

If you are the Stanford author(s) of a protocol that will be administered at multiple sites,  the SRC requires that you use the following template and guidelines for your protocol document.
Investigator Initiated Multi-site Trials Protocol Document Template

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If a Protocol Statement of Support form is received two weeks prior to an SRC meeting date, every effort will be made to assign the study to that meeting date.


SRC 2009 Meeting Dates

(all meetings are at noon)

Monday
January 12th

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Friday
January 23rd
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Monday
February 9th

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Friday
February 20th
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Monday
March 9th

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Friday
March 20th
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Monday
April 13th

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Friday
April 24th
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Monday
May 11th

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Friday
May 22nd
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Monday
June 8th

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Friday
June 19th
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Monday
July 13th

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Friday
July 24th
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Monday
August 10th

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Friday
August 21st
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Monday
September 14th

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Friday
September 25th
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Monday
October 12th

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Friday
October 23rd
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Monday
November 9th

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Friday
November 20th
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Monday
December 7th

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Review and Reporting Requirements by Type of Study

The NCI requires that we collect and report data on cancer studies listed below by type except for retrospective chart reviews. However, not all of these studies must be reviewed prior to opening by the Cancer Center Scientific Review Committee (SRC). The table below lists for each type of study, whether scientific review is required (denoted by a check mark) or not (with N/A), and whether data is to be collected in the Oncore database for reporting to the NCI.

The definitions of the different types of studies are also summarized.

Type of Study
SRC Review
Required
Oncore
Data Collection
Therapeutic (agent or device)
Yes
Yes
Behavioral and nutritional interventions
Yes
Yes
Tissue, Body Fluids Prospective Studies with scientific hypothesis
Yes
Yes
Diagnostic impacting a medical decision
Yes
Yes
Screening, early detection
Yes
Yes
Prevention with scientific hypothesis
Yes
Yes
Supportive care
Yes
Yes
Epidemiologic
Yes
Yes
Companion, ancillary, or correlative studies with scientific hypothesis
Yes
Yes
Correlative laboratory based studies using specimens to assess risk, outcomes, response to therapy
Yes
Yes
Observational
Yes
Yes
Retrospective chart reviews
N/A
N/A
Compassionate use studies
N/A
N/A
Umbrella protocols
N/A
N/A

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References

·····SRC SOP Page 1: See http://cancer.stanford.edu/trials/admin/forms.html
Scientific review applies to all phases of clinical therapeutic intervention, behavioral clinical trials, tissue and body fluid research, and diagnostic trials that impact medical decision making for the treatment of cancer patients.

····From NCI Summary 4 Guidelines 06/06: See http://cancercenters.cancer.gov/documents/Summaries6_06.pdf

Questions

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Data and Safety Monitoring Committee (DSMC)

The DSMC is intended to oversee all aspects of data monitoring, verify data validity and integrity, and ensure the safety of participants in all cancer clinical trials, including institutionally sponsored, investigator initiated trials, and those trials without external monitoring that are active at Stanford University Cancer Center. All cancer clinical trials require monitoring commensurate with the degree of risk involved in the study subject participation, as well as the size and complexity of the study.


DSMC 2009 Meeting Dates
(all meetings are at noon)

Monday
January 26th

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Monday
February 23rd

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Monday
March 16th

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Monday
April 20th

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Tuesday
May 18th

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Monday
June 15th

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Monday
July 20th

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Monday
August 17th

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Monday
September 21st

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Monday
October 19th

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Monday
November 16th

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Monday
December 14th

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Questions

References

·····DSMC SOP Page 1: See http://cancer.stanford.edu/trials/admin/forms.html

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Safety Reporting

The DSMC is required to review ALL SAEs. Adverse Event Standard Operating Procedure Report all Adverse Events to the , who will submit these reports to the IRB, DSMC, and all other required regulatory entities in a timely manner. Please complete the Adverse Event Communication Form to submit with your reports.

See Events and Information that Require Prompt Reporting to the IRB for guidance on Stanford's IRB/Cancer Center adverse event reporting policy. See Sample Letter for Sponsors if you need to request a report assessment from the sponsor's monitoring entity. This letter refers to two attachments; the IRB guidance on Events and Information that Require Prompt Reporting to the IRB and Information Needed from Sponsor .

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Protocol Review and Monitoring System Process

To view the PRMS work process open the SRC Workflow document.

Questions

Staff with specific questions can contact the PRMS Office:

Protocol Review & Monitoring System
Stanford Cancer Center, Room 2325
875 Blake Wilbur Drive, MC 5822
Stanford, CA 94305

Phone: (650) 724-4926
Fax: (650) 725-9204
Email:

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Staff

Susan Knox, PhD, MD, Associate Professor of Radiation Oncology and Director of PRMS
sknox@stanford.edu 650-725-2720
Dr. Knox oversees the direction of the PRMS at Stanford. She is the chair of the Data and Safety Monitoring Committee (DSMC). She ensures that PRMS core operates in accordance within the established National Cancer Institute (NCI) guidelines for Comprehensive Cancer Centers.
 
Miriam Bischoff, MS, MBA, Facility Director, Protocol Review and Monitoring System
miriamb@stanford.edu 650-498-4536
Miriam implements the policies specified by Dr. Knox and the Protocol Review and Monitoring System Executive Committee. She supervises the staff of the PRMS.
 
Jennifer Henniger, PRMS Coordinator
henniger@stanford.edu 650-724-4926
Jennifer co-implements the operations of the PRMS’ two committees. Jennifer is the primary liaison for the Scientific Review Committee (SRC). In this role, Jennifer is responsible for receiving study materials submitted for scientific review, preparing and distributing these materials to committee member reviewers, organizing meeting agendas, and preparing all follow-up communications.
 
Melanie Hines , PRMS Coordinator
melhines@stanford.edu 650-724-1898
Melanie co-implements the operations of the PRMS’ two committees. Melanie is the primary liaison for the Data Safety and Monitoring Committee (DSMC). In this role, Melanie is responsible for initiating monitoring, receiving study materials for monitoring, organizing the monitoring sessions, preparing monitoring reports, meeting agendas, and follow-up communications.

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