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.
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.
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
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. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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 |
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
- Clinical Research Category:
- clinical trials involving an agent or device;
- clinical trials involving other types of interventions (i.e. behavioral modification, nutritional protocols, etc.);
- epidemiologic, outcome, or other observational studies;
- ancillary or correlative studies associated with a clinical trial or other biological studies using clinical specimens that can be linked to individual patient or participant data.
- Therapeutic (The) Trial: Clinical trials with therapeutic intent using drugs, radiation, surgery, other biological agents, or behavioral or other interventions.
- Prevention (Pre) Trial: Clinical trials for the modulation of cancer risk and inhibition of cancer progression using chemoprevention drugs, nutritional, dietary, behavioral, or other interventions.
- Supportive Care (Sup) Trial: Clinical trials intended to improve the comfort and quality of life for the patient using drugs, nutritional, dietary, behavioral or other interventions.
- Screening (Scr), Early Detection (Det), or Diagnostic (Dia) Trials: Clinical trials directly testing the efficacy of devices, techniques, procedures; or tests for earlier or more accurate detection or diagnosis of disease.
- Epidemiologic (Epi), Observational (Obs), or Outcome (Out) Trials: Studies among cancer patients and healthy populations that involve no intervention or alteration in the status of the participants, e.g., surveillance, risk assessment, outcome, environmental, and behavioral studies.
- Ancillary (Anc) Trial: Auxiliary studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies included must be linked to an active trial or epidemiologic or other study and should include only patients accrued to that trial or study. Only studies that can be linked to individual patient or participant data should be reported.
- Correlative (Cor) Trial: Laboratory based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc. Only studies that can be linked to individual patient or participant data should be reported.
Questions
- ···For SRC questions contact Jennifer Henniger at henniger@stanford.edu or 4-4926.
- ···For Oncore questions contact Deb Bouvier at dbouvier@stanford.edu or 6-0421.
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.
|
||||||||||||||||||||||||||||||||||||
|
Questions
- ···For DSMC questions contact Melanie Hines at melhines@stanford.edu or 4-1898.
- ···For Oncore questions contact Deb Bouvier at dbouvier@stanford.edu or 6-0421.
References
·····DSMC SOP Page 1: See http://cancer.stanford.edu/trials/admin/forms.html
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 .
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 94305Phone: (650) 724-4926
Fax: (650) 725-9204
Email:
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. | |
Trial Administration