Clinical Research Support

Scientific Review Committee

This second-stage review ensures studies are assessed for scientific merit and integration of the research effort with regard to competing protocols and Cancer Consortium research priorities. 

Mission and Objectives

All cancer-related intervention research protocols being submitted must receive scientific review as mandated by NCI. All trials are included -- industry-sponsored, NCTN, NIH, unfunded -- regardless of funding source. Clinical Research Support coordinates the scientific review for the Cancer Consortium. The scientific review process has been structured to support the full range of research embodied by the Cancer Consortium.

Scientific Review Committee

To accommodate the breadth of expertise required for scientific review, membership is comprised of two multi-disciplinary subcommittees. Expertise represented in each subcommittee includes laboratory science, clinical trial design and conduct, biostatistics, pharmacy, nursing, oncology, and prevention, cancer control and population-based science specialties.

Elements of SRC review:

  • Scientific merit and interest
  • Potential clinical significance
  • Study design
  • Fit of eligibility criteria with the profile of Consortium patients
  • Value added by participation of Consortium investigators
  • Fit of the trial within the context of other open trials
  • Feasibility
  • Anticipated accrual
  • Potential for enrollment of women, minorities and individuals across the lifespan

Contact CRScommittees@fredhutch.org if you have any questions. 

Membership

SRC membership comprises a variety of scientific disciplines with representatives from each Consortium institution.

SRC A Members & Expertise

  • Michael Schweizer, MD (Chair): Solid Tumor, Genitourinary Malignancies, Phase I, Immunotherapy
  • John Thompson, MD (Co-Chair): Solid Tumor, Melanoma, Phase 1, Transplant, Immunotherapy
  • William Gwin III, MD: Solid Tumor, Breast Oncology
  • David Zhen, MD: Solid Tumor, Gastrointestinal Malignancies
  • John Gore, MD, MS, FACS: Solid Tumor, Urology, Surgery, Basic Science
  • Kalyan Banda, MD: Solid Tumor, Gynecologic Oncology
  • Todd Yezefski, MD, MS: Solid Tumor, Genitourinary Malignancies, Prostate Cancer
  • Rafael Santana-Davila, MD: Solid Tumor, Lung, Head and Neck Malignancies, Immunotherapy
  • Viswam Nair, MD, MS: Solid Tumor, Lung, Head and Neck Malignancies, Imaging
  • Anna Halpern, MD: Hematologic Malignancies, Transplantation
  • Kanwaldeep Mallhi, MD: Hematologic Malignancies, Transplantation, Pediatric Oncology, Radiation Oncology
  • Monica Thakar, MD:  Hematologic Malignancies, Pediatric Oncology, Transplantation, Phase I, Immunotherapy
  • Phuong Vo, MD: Hematologic Malignancies, Transplantation, Radiation Oncology, Basic Science
  • Cecilia Yeung, MD: Hematologic Malignancies, Transplant Surgery, Hematopathology, Basic Science
  • Rachel Ceballos, PhD: Behavioral Sciences, Cancer Prevention
  • Parth Shah, PharmD, PhD: Behavioral Sciences, HICOR, Pharmacy
  • Johanna Lampe, PhD, RD: Behavioral Sciences, Cancer Prevention
  • Qian (Vicky) Wu, PhD: Biostatistics
  • Ching-Yun Wang, PhD: Biostatistics
  • Laurel Rech: Patient Advocacy

 

SRC B Members & Expertise

  • Vivian Oehler, MD (Chair): Hematologic Malignancies, Transplantation, Basic Science
  • Ryan Lynch, MD (Co-Chair): Hematologic Malignancies, Transplantation, Immunotherapy
  • Kevin Cheung, MD: Solid Tumor, Breast Oncology, Basic Science
  • Stacey Cohen, MD: Solid Tumor, Gastrointestinal Malignancies
  • John K. Lee, MD, PhD: Solid Tumor, Genitourinary Malignancies, Basic Science, Immunotherapy
  • Cristina Rodriguez, MD: Solid Tumor, Head and Neck Malignancies, Radiation Oncology
  • Navin Pinto, MD: Solid Tumor, Sarcoma, Pediatric Oncology, Immunotherapy
  • Michael Wagner, MD: Solid Tumor, Sarcoma, Surgery, Basic Science, Phase I, Immunotherapy
  • Lauri Burroughs, MD: Hematologic Malignancies, Pediatric Oncology, Transplantation, Radiation Oncology, Immunotherapy
  • Mazyar Shadman, MD, MPH: Hematologic Malignancies, Transplantation, Immunotherapy
  • Johnnie Orozco, MD, PhD: Hematologic Malignancies, Transplantation, Basic Science, Radiation Oncology, Immunotherapy
  • George Georges, MD: Hematologic Malignancies, Transplantation
  • Sylvia Lee, MD: Solid Tumor, Immunology, Lung, Head and Neck Malignancies
  • Vyshak Venur, MD: Solid Tumor, Neurologic Oncology, Immunotherapy
  • Steve Schwartz, PhD: Behavioral Sciences, Epidemiology
  • Eric Chow, MD, MPH: Behavioral Sciences, Pediatric Oncology, Cancer Prevention
  • Kerryn Reding, PhD, MPH, RN: Behavioral Sciences, Cancer Prevention, Nursing
  • Yingqi Zhao, PhD: Biostatistics
  • Yingye Zheng, PhD: Biostatistics
  • Melissa Locke: Patient Advocacy
  • Jason Johnson: Patient Advocacy

Ad-Hoc Members & Expertise

  • Ted Gooley, PhD: Biostatistics
  • Michael LeBlanc, PhD: Biostatistics

Frequently Asked Questions

What is the process for Scientific Review?

1. Study team completes required documents for submission.

  • Study team should refer to the submission deadlines when planning for submission to the SRC.
  • Study team should confirm that they are using the most current versions of the forms and document templates by downloading from websites each time.
  • Study team will need to complete all required documents in their entirety and assure the PI has reviewed everything before signing.
  • Study team submits all documents & required signature pages with submission.

2. Study team completes submission in OnCore.

3. SRC Committee Coordinator reviews documents and issues queries.

  • Any issues that must be resolved to meet minimum SRC submission standards will be sent to the study team via queries in OnCore before placing the study on an agenda.

4. SRC Committee Coordinator places submission on agenda after queries resolved.

5. The SRC issues a result letter.

  • Studies that are approved as written can move forward to IRB submission. Studies that are conditionally approved or disapproved require a response to SRC that is approved prior to submitting to the IRB of record.

What documents are required for initial SRC review?

Are there deadlines for SRC submissions?

Use the dates below to plan your new Cancer Consortium SRC submission according to your overall startup timelines. Submissions received after the deadlines will be scheduled for the next available SRC meeting.

All submissions to SRC must be made through OnCore. Please keep in mind that CRS will submit a query if a submission is not complete for review. CRS must receive responses to queries for a submission to be considered complete and ready for review at the listed meeting.

For additional OnCore instructions, please see the CTMS Training Documents

For the IRB Committees' meeting schedule, please see the Institutional Review Office's page.

 

*HOLIDAY CLOSURE, RESCHEDULED MEETING TBD

What modifications require SRC review?

If an investigator-initiated study is subject to Scientific Review, regardless of the IRB of record, major modifications to the protocol need to be reviewed by the SRC that originally reviewed and approved the study. If scientific elements are modified, as described in the SRC Modification Form, the revision must be submitted for full SRC review.

In addition to the SRC Modification Form, a clean protocol and protocol with tracked changes is required for SRC submission.

Final SRC approval documentation can then be submitted with the revision to the IRB of record. If no scientific elements are modified or if the study has an industry or NCTN sponsor, no SRC review of the modification is required.

Does the SRC monitor ongoing studies?

The SRC monitors ongoing studies for scientific progress, including accrual rates according to the Consortium Low Accrual Policy. For additional information on low accrual reviews and requirements, consult the SRC Low Accrual Job Aid.

What is required for Multi-site IIT PRMS Reliance?

For multi-site institutional trials, a single full review at an NCI-designated Cancer Center with an NCI-approved PRMS (Scientific Review Committee) is required. If the trial received full approval, the other sites are responsible only for an expedited review. 

To submit an approved multi-site institutional trial to our Consortium SRC, you must include the External PRMS Initial Approval Letter in addition to the protocol and Research Group Review form. This letter must include a clear statement of full PRMS/SRC approval of the new protocol and the status of PRMS committee (NCI-approved PRMS.) If the External PRMS Initial Approval Letter does not include the NCI approval of the PRMS committee, please submit this documentation as an External PRMS NCI Status Document to the SRC. External PRMS documentation is required to qualify for expedited SRC review. Submissions without External PRMS documentation will default to full committee review.

The Cancer Consortium PRMS has been fully approved by NCI and can serve as the PRMS of record for other sites. To provide proof of PRMS review to another site, include the SRC Meeting Result Letter (distributed to the PI after SRC Initial Review) and documentation of our PRMS status, found here.

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