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 (SRC)

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

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.

Frequently Asked Questions

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.
 
SRC schedule

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.

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.

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.

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.

VIEW THE COMMITTEES

SRC A Members  |  SRC B Members  |  Ad-Hoc Members

SRC A Members & Expertise

Kalyan Banda, MD

Solid Tumor, Gynecologic Oncology

Scott Furlan, MD

Pediatric Oncology, Hematologic Malignancies, Immunotherapy

Fei Gao, PhD

Biostatistics

John Gore, MD, MS, FACS

Solid Tumor, Urology, Surgery, Basic Science

William Gwin III, MD

Solid Tumor, Breast Oncology

Anna Halpern, MD

Hematologic Malignancies, Transplantation

Johanna Lampe, PhD, RD

Behavioral Sciences, Cancer Prevention

Viswam Nair, MD, MS

Solid Tumor, Lung, Head and Neck Malignancies, Imaging

Laurel Rech

Patient Advocacy

Rafael Santana-Davila, MD

Co-Chair, SRC A Committee

Solid Tumor, Lung, Head and Neck Malignancies, Immunotherapy

Michael Schweizer, MD

Chair, SRC A Committee

Solid Tumor, Genitourinary Malignancies, Phase I, Immunotherapy

Parth Shah, PharmD, PhD

Behavioral Sciences, HICOR, Pharmacy

Monica Thakar, MD

Hematologic Malignancies, Pediatric Oncology, Transplantation, Phase I, Immunotherapy

John Thompson, MD

Solid Tumor, Melanoma, Phase 1, Transplant, Immunotherapy

Phuong Vo, MD

Hematologic Malignancies, Transplantation, Radiation Oncology, Basic Science

Trang VoPham, PhD, MPH, MS

Behavioral Science, Epidemiology

Ching-Yun Wang, PhD

Biostatistics

Cecilia Yeung, MD

Hematologic Malignancies, Transplant Surgery, Hematopathology, Basic Science

Todd Yezefski, MD, MS

Solid Tumor, Genitourinary Malignancies, Prostate Cancer

David Zhen, MD

Solid Tumor, Gastrointestinal Malignancies

Jonathan Yang, MD, PhD

Radiation Oncology

SRC B Members & Expertise

Neel S. Bhatt, MBBS., MPH

Hematologic Malignancies, Pediatric Oncology

Kevin Cheung, MD

Solid Tumor, Breast Oncology, Basic Science

Eric Chow, MD, MPH

Behavioral Sciences, Pediatric Oncology, Cancer Prevention

Stacey Cohen, MD

Solid Tumor, Gastrointestinal Malignancies

Clemens Grassberger, PhD

Radiation Oncology

Jessica Hawley, MD, MS

Solid Tumor, Genitourinary Malignancies

Leona Holmberg, MD, PhD

Hematologic Malignancies, Transplantation

Jason Johnson

Patient Advocacy

Sylvia Lee, MD

Solid Tumor, Immunology, Lung, Head and Neck Malignancies

Wendy Leisenring, ScD

Biostatistics

Melissa Locke

Patient Advocacy

Ryan Lynch, MD (Co-Chair)

Hematologic Malignancies, Transplantation, Immunotherapy

Vivian Oehler, MD (Chair)

Hematologic Malignancies, Transplantation, Basic Science

Johnnie Orozco, MD, PhD

Hematologic Malignancies, Transplantation, Basic Science, Radiation Oncology, Immunotherapy

Kerryn Reding, PhD, MPH, RN

Behavioral Sciences, Cancer Prevention, Nursing

Cristina Rodriguez, MD

Solid Tumor, Head and Neck Malignancies, Radiation Oncology

Steve Schwartz, PhD

Behavioral Sciences, Epidemiology

Mazyar Shadman, MD, MPH

Hematologic Malignancies, Transplantation, Immunotherapy

Vyshak Venur, MD

Solid Tumor, Neurologic Oncology, Immunotherapy

Edus Houston Warren, MD, PhD

Global Oncology, Immunotherapy, Vaccine and Infectious Diseases

Yingye Zheng, PhD

Biostatistics

Ad-Hoc Members & Expertise

Ted Gooley, PhD

Biostatistics

Michael LeBlanc, PhD

Biostatistics

Questions