Scientific Review Committee (SRC)
The SRC is charged with providing peer review of local, national, and international research studies involving cancer patients treated at Lucile Packard Children's Hospital and Stanford Hospital and Clinics; and study participants involved in cancer-related research at Stanford University. Scientific review also applies to interventional studies based at the Cancer Prevention Institute of California (CPIC). SRC review is a requirement of the National Cancer Institute as part of our cancer center designation. Scientific review is required for all clinical interventional studies that involve cancer, cancer prevention, or survivorship. Scientific review is also required for non-interventional studies involving cancer, cancer prevention, or survivorship unless the non-interventional study has undergone peer review by an organization that the NCI considers acceptable; this list of organizations can be found at: https://cancercenters.cancer.gov/documents/fundorg.pdf; these studies do still require OnCore entry. Prospective studies of tissue and/or body fluids with a scientific hypothesis that do not undergo review by the Stanford Cancer Institute’s Tissue Bank in lieu of SRC review, and have not undergone peer review to obtain funding, require review by the SRC. The primary focus of scientific review is on the scientific merit, feasibility, and utilization of Cancer Center resources.
SRC Submission Process
How to Submit an Initial SRC Application:
- (If applicable) All investigator Initiated studies must comply with Stanford Cancer Center’s guidelines and templates prior to either SRC or IRB submissions.
- All cancer studies are required to undergo SRC review with the exception of prospective biospecimen studies that are not investigating a scientific hypothesis and compassionate use studies for a single patient. All biospecimen studies that are collecting materials for prospective studies should go through the Tissue Procurement Facility.
- An IRB application must be submitted to Stanford’s Administrative Panels on Human Subjects.
- As soon as the IRB application is submitted, complete the entire Protocol Registration Form and email it to [email protected]. The Protocol Registration Form is used to create the protocol record in OnCore and the Stanford Clinical Trials database, and subsequently, ClinicalTrials.Gov.
- Complete a Protocol Statement of Support (PSOS) form for the appropriate Clinical Research Groups (CRG).
- All interventional trials must complete a CRG Flowchart for the appropriate CRG.
- Submit PSOS and Flowchart to the SRC per instructions on the forms.
SRC Pre-Review of Investigator Initiated Studies:
All Investigator-initiated protocols submitted to the SRC will be pre-reviewed prior to the scientific review by the SRC; the purpose of the pre-review is to ensure that protocols contain all the required elements and they are organized in a consistent manner in the appropriate format. The Checklist can be found via the URL below and is intended to be helpful in the protocol writing process. Protocols that lack the necessary information will not be assigned SRC reviewers until the protocol has been revised. Please allow sufficient time for this pre-review and revision (if necessary) process. We will make every effort to be prompt in sending PIs the comments from the pre-review and hope that this process will eventually expedite the protocol development process. The pre-review will allow the SRC reviewers to focus on the scientific merit of research protocols and to ensure they conform to the research objectives and priorities of the Stanford Cancer Center. For questions on the SRC pre-review process, contact Jennifer Dylewski ([email protected], (650)-724-4926).
The protocol templates for Interventional and Non-interventional studies are in the CCTO website (https://cancer.stanford.edu/trials/admin/sops_and_templates.html).
How to Submit a Renewal to the SRC:
- The Protocol Director will be notified by the SRC when a study is up for annual renewal.
- Complete a Renewal Protocol Statement of Support form for the appropriate CRG and submit to the SRC.
How to Submit a Modfication to the SRC:
- Any changes to the protocol’s study design and/or accrual numbers must be submitted to the SRC to determine if re-review is appropriate.
- Send a completed IRB modification application form to [email protected].
- The Protocol Director will be notified by the SRC regarding whether re-review by the SRC is required.
The CCTO Regulatory Team is available to assist with the IRB and SRC application process.
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SRC Resources
- Scientific Review Committee SOP
Oct 4, 2011 - SRC Appeal Process May 8, 2012
- SRC Workflow document
- Procedure for Informing Principal Investigators of Permission to Commence Cancer Studies Jul 25, 2007
- Protocol Statement of Support - New Study and Renewal
- CRG Flow Chart
- SRC Policies
Sep 22, 2010 - SRC Voting Guidelines Jan, 2011
- Investigator Initiated Protocols Pre-Review Checklist Mar, 2011
- SRC Cancer Registry Data 2010
Jul, 2011 - SRC Cancer Pediatrics Registry Data 2010 Jul, 2010
Trial Administration