SRC Submission Process

Initial SRC Submission

For all studies that require SRC review, the initial review is initiated once the PI or designee submits the completed required documents to the SRC.

The submission should be done via the SCI Cancer Clinical Trials Office (CCTO) Intake REDCap Portal: http://med.stanford.edu/ccto/request.html

The following documents are required to initiate the SRC review:

Protocol

All applicable investigator initiated studies (IIT) must comply with SCI guidelines and appropriate protocol templates prior to either SRC or IRB submissions.
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. Protocols that lack the necessary information will not be assigned SRC reviewers until the protocol has been revised. 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 SCI.
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 to help expedite the protocol development process.

Protocol Statement of Support (PSOS)

Complete the PSOS form for the appropriate Clinical Research Group (CRG) from which the study plans to recruit participants.
- PSOS Form can be downloaded here: http://med.stanford.edu/cancer/research/trial-support/src/research-groups.html.
- For Population Science studies, please use Populations Science PSOS Form.
The protocol review along with CRG priority score form evaluation and PSOS approval by the CRG must be completed at a CRG meeting. Completed signed forms should be provided for SRC review.
- Studies involving multiple CRGs require a PSOS form, flow chart, and identification of a sub-I for each CRG from which the study plans to recruit participants.
- If study does not fall under one of these groups, the 'various/other’ option for the CRG may be used when completing the PSOS form. The 'various/other’ PSOS form is signed by the Associate Director for Clinical Research after meeting with the PI to discuss the study.
- Exceptions: Review at a CRG meeting and completion of CRG Priority Score Form is not required for Population Science Studies. For complete details, please review Population Science Studies section below.

CRG priority score form (CPSF)

CPSF documents the CRG's evaluation of the protocol based on the overall anticipated impact of the study and its alignment with SCI priorities including sponsor type, funding source, anticipated impact of study to cancer care, principal investigator (PI) leadership, ability to accrue, anticipated impact to catchment area and translation of Stanford science.
CPSF Form can be downloaded here: http://med.stanford.edu/cancer/research/trial-support/src/research-groups.html
The CPSF should be reviewed at a CRG meeting along with the review of the protocol and PSOS. CPSF should be signed by the CRG leader or designee who also signed the PSOS.
Exceptions: CRG Priority Score Form is not required for Population Science Studies

Study Flowchart (For interventional trials)

A flow chart is used to evaluate the fit of open, pending studies in relation to the proposed trial and to assess how competing studies are prioritized in terms of enrollment and if there an adequate patient population for both. All disease-related flow charts are published on the SRC website.
All interventional trials (with the exception of pediatrics and population science studies) must complete and provide a Flowchart.
- Download the appropriate CRG flowchart. Indicate where the protocol that is being submitted for SRC review fits in relation to other studies currently open or planned (see flowchart instructions).
- If competing studies are open or planned, the priority of the protocol under review compared to the competing trials is also indicated.
- If the appropriate flowchart does not exist, create a new flowchart using the blank protocol template and mark up a copy by hand.

For questions or assistance with flowcharts contact SRC-Office@Stanford.edu

Population Science Studies

All new cancer-related population science studies should be submitted to SRC for review and approval if ALL 4 of the following criteria are met:

Meet the definition of cancer-relevant research (above), and
Are hypothesis-driven, and
Have an intervention assigned to the participant by the researcher, and
Have not undergone an external peer review that meets NCI’s requirement for peer review²

Cancer-relevant population science studies without an intervention assigned (e.g., observational studies) do not require SRC review.
SCI had defined cancer-relevant research as any investigation lifestyle, e.g. obesity status, physical activity, diet/nutrition (including vitamin supplements), alcohol, tobacco control, UV light exposure, sleep and stress management, and environmental factors that are known or determined to be associated with any cancer, as well as behavioral research which aims to improve these risk factors.

²NCI Organizations with Peer Review Funding Systems https://cancercenters.cancer.gov/documents/PeerReviewFundingOrganizations508C.pdf

How to Submit a New Study to the SCI for OnCore Registration & SRC Review

New and amended studies are submitted through CCTO Intake at https://med.stanford.edu/ccto/request.html
Documents required for SRC submission:

Final protocol For detailed requirements, please refer to Protocol section above.
Protocol Statement of Support (PSOS) form_ Population Sciences
- Principal Investigator (PI) completes the Population sciences _PSOS form and also obtains sign-off by biostatistician responsible for the statistical design of the study on the PSOS (biostatistician signoff applicable to Stanford investigator-initiated trials) PSOS Form can be downloaded at: http://med.stanford.edu/cancer/research/trial-support/src/research-groups.html. Use PSOS form initial_ Population Sciences
- SRC facilitates obtaining approval signature for the PSOS from a SCI Population Science leader (Dr. Melissa Bondy, Dr. Marcia Stefanick, Dr. Allison Kurian or Dr Esther John).
- The form is required for initial study review only

Resources and Tools

Resources for research participant engagement and retention available at: https://med.stanford.edu/spectrum/study-team-resources/participant-engagement.html
Resources for study design and analysis for research studies available at Stanford Quantitative Sciences Unit (QSU): https://med.stanford.edu/qsu.html
OnCore is Stanford’s secure centralized system for tracking cancer clinical research. As a requirement of our NCI Cancer Center designation, cancer-related clinical research must be tracked through a centralized database. https://med.stanford.edu/ccto/services/oncore.html
- Questions related to SCI OnCore: ccto-oncore@stanford.edu

For any questions related to the SRC submission process, please contact SRC-Office@stanford.edu

Protocol Amendments

All Protocol amendments, following initial SRC approval of the protocol, must be submitted to SRC through the Intake REDCap Portal Form. SRC administrative coordinator reviews each amendment submission to assess if the amendment meets the SRC review criteria
Protocol amendments must be reviewed and approved by the SRC, in addition to the IRB, if there are changes that impact the study design, study population, sample size and/or risk to study participants.

Amendment Review submission:

Submit the following documents via Intake REDCap Portal Form:

Protocol Amendment
1. For IITs, please ensure protocol version dates are updated and consistent throughout the document.
Tracked version of the revised protocol with summary of changes

All SCI SRC reviews and determinations are documented in OnCore (SRC review section).

If SRC review was required for the amendment per the SRC review criteria, the PI will be notified in writing once the amendment review is completed by the SRC.
If the protocol amendment does not require review, SRC review section in OnCore is updated to indicate that review was not required.

SRC also reviews protocols at the following timepoints:

SRC Accrual Review Process

Accrual reviews are conducted by calculating the Accrual Index (AI)

AI = Actual accrual / Anticipated accruals
Anticipated accruals = Target Annual Accrual x Years Open
Years Open = Date of calculation – Open to accrual date / 365

6 Month Accrual Review:

All open to accrual interventional studies (excluding rare diseases, pediatrics, and Phase 1 trials, with limited participants slots) are reviewed by the SRC, at approximately 6 months’ time from their open to accrual date, to assess if accruals are proceeding adequately.
If the accrual is less than half of the institutional target annual accrual goal, a low accrual notification is sent to the study principal investigator (PI).

Annual Accrual Review (12 Months):

All interventional clinical trials (except pediatric studies) that are open to accrual are monitored at least annually for scientific progress including accrual progress, continued scientific relevance, safety and compliance.
Studies that have accrued less than 50% of their annual target accrual will be re reviewed in 6 months.
If the accrual has not significantly improved, consideration will be given to study closure.

Accrual Review at 18 Months:

SRC re reviews accrual for studies that were identified to have an accrual of less than 50% of their annual target accrual. SRC will require such studies to be closed to accrual if the study enrollment is not improved by 18 months and continues to be below an Accrual Index of 0.25.
For studies that have an Accrual Index of less than 0.5 but more than 0.25, a low accrual notification is sent to the PI.
Annual Accrual Reviews (24 Months and onwards):
All interventional trials that continue to remain open to accrual at 24 months and onwards, SRC reviews their accrual progress annually.
If a study has an Accrual Index of 0.5 or less, SRC will require such studies to be closed to accrual.

Important Reminders:

Please note that the study closure decisions may not be appealed.
OnCore is the data source for study status and accrual reviews by the SRC.
Please ensure study status as well as participant enrollment is kept updated, to allow SRC to accurately calculate the Accrual Index.
Resources for research participant engagement and retention available at: https://med.stanford.edu/spectrum/study-team-resources/participant-engagement.html

Annual SRC Reviews

All clinical trials that are open to accrual are monitored at least annually for scientific progress including accrual progress, continued scientific relevance, and safety and compliance.

Renewal Application Process

Annual SRC reviews coincide with the study’s IRB renewal date. The PI will be notified by the SRC when a study is due for annual renewal.
Please note that annual SRC review is not required for the following trials*:
- Rare disease Rare disease: Incidence rate of ≤ 5,000 newly diagnosed cases of any specific cancer per year)
- Pediatric trials, and
- Non-interventional studies

Complete a Renewal PSOS form (rPSOS).
The renewal PSOS form should be reviewed and signed at a CRG meeting.
Submit the completed form via the Intake REDCap Portal Form. Completed Renewal PSOS forms can also be emailed directly to SRC-Office@Stanford.edu
SRC review determination is conveyed to the PI in writing.

Continued Scientific Relevance Reviews at 5 years

All interventional studies that initially opened to accrual ≥ 5 years ago and continue to remain open to accrual, regardless of their status of rare disease/pediatric trial, are reviewed for their continued scientific relevance by the SRC.

The PI will be notified by the SRC when a study is due for 5 year continued scientific relevance review.
The PI is requested to provide rationale for continued scientific relevance of the study by completing the rPSOS*.
Annual reviews of scientific validity, for the duration the study is open to accrual, will be required thereafter.
SRC review determination is conveyed to the PI in writing.

*Though pediatric/rare interventional trials are exempt from annual SRC reviews, they are reviewed for continued scientific validity and relevance after 5 years have passed since they first opened to accrual and then each year that they continue to stay open to enrollment.

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