In accordance with National Cancer Institute mandates, all cancer-related interventional research must obtain endorsement from the appropriate Research Group(s). The Cancer Consortium employs a two-stage Protocol Review and Monitoring System (PRMS) to comprehensively support research.
The first-stage review, known as the Research Group review, is documented in the Research Group Review Summary available at https://redcap.link/rgr. This form is completed by the Research Group(s) during their protocol evaluation.
Key Contacts
PRMS@fredhutch.org for additional information or assistance with Research Group reviews
This first-stage review ensures Research Groups prioritize trials for their patient population and reduce the number of studies that are low-accruing due to competing trials.
To initiate a Research Group review, please refer to the contact information for the appropriate group provided on this site. In your initial outreach, include the following details:
- Protocol
- Additional relevant documents (e.g., Investigator's Brochure, appendices)
- Sponsor information
- Additional context, such as prior reviews, anticipated start-up timeline or any special considerations
The Director or Admin will reply with scheduling details and inform you if any additional documents or information are needed.
Each trial must have one completed review form that identifies the primary Research Group and any collaborating groups, as applicable.
In most cases, the appropriate Research Group will be clear based on the investigator's affiliation or the study focus (e.g., a breast cancer study will be reviewed by the Breast Oncology Group).
For trials that involve multiple Research Groups, please consult with the Directors of the relevant groups to determine which should serve as the primary group for the review.
Research Groups convene to assess their research portfolios and evaluate the scientific feasibility and merit of proposed trials. Prior to the meeting, the Research Group will inform you if your attendance is required or if any additional materials must be provided. Following the meeting, the Research Group will communicate the outcome of the review, including any required follow-up.
If the trial is approved, a copy of the Research Group Review Summary is provided to include in the SRC submission. Submission to the SRC must take place within three months of the Research Group review to ensure timely and relevant reviews.
Additional information can be found in the Research Group Review Job Aid.
Research Group reviews are documented in the Research Group Review Summary available at https://redcap.link/rgr.
At the conclusion of a Research Group review, the Director or designee completes the form and returns a copy to the investigator and study team. The completed form must be included in the SRC submission.
Research Group disapprovals must be reported at https://redcap.link/rgr or emailed to rejectedprotocols@fredhutch.org.
Research Group Review must occur before submission for SRC review. These reviews are sequential and not concurrent.
A new study submission will not be scheduled for SRC review until the completed Research Group Review Summary is submitted.
VIEW THE GROUPS
Breast Oncology
Director: Jennifer Specht, MD
Co-Director: Hannah Linden, MD
Admin: breastresearch@fredhutch.org
Gastrointestinal Oncology
Director: Gabriela Chiorean, MD
Co-Director: William Harris, MD
Admin: khansen3@fredhutch.org
Global Oncology
Director: Edus H. Warren, MD, PhD
Co-Director(s):
Manoj Menon, MD, MPH
Warren Phipps, MD, MPH
Admin: globaloncology@fredhutch.org
GU/Prostate Oncology
Director: Michael Schweizer, MD
Co-Director(s):
Peter Nelson, MD
Evan Yu, MD
Admin: ppanlas2@fredhutch.org
Gynecologic Oncology
Director: Heidi J. Gray, MD
Co-Director(s):
Barbara A. Goff, MD
John B. Liao, MD, PhD
Elizabeth M. Swisher, MD
Hematologic Malignancies
Director: Ajay Gopal, MD, FACP
Director, Myeloid Malignancies:
Mary-Elizabeth Percival, MD
Director, Multiple Myeloma:
Andrew Cowan, MD
Admin:
uwhemeresearchstartup@fredhutch.org
uwhemmalreg@fredhutch.org
Thoracic, Head, and Neck Oncology
Director: Christina Baik, MD, MPH
Co-Director(s):
Keith Eaton, MD, PhD
Cristina Rodriguez, MD
Admin: hnlstartup@fredhutch.org
Pediatric Oncology
Director: Sarah Leary, MD
Co-Director(s):
Colleen Annesley, MD
Marie Bleakley, MD, PhD, MMSC
Admin: pedspc@fredhutch.org
Population Sciences
Hematopoietic Cell Transplantation (CIM)
Director: Geoffrey Hill, MD, FRACP, FRCPA
Co-Director(s):
Elizabeth Krakow, MD, CM, MS
Filippo Milano, MD, PhD
Admin:
crd-directors-office@fredhutch.org
lsaito2@fredhutch.org
Phase 1 Clinical Trials
Director: Michael Schweizer, MD
Admin:
phase1clinicaltrial@fredhutch.org
baskovi2@fredhutch.org