Research Oversight: Robert H. Lurie Comprehensive Cancer Center of Northwestern University : Feinberg School of Medicine: Northwestern University

Provides an integrated, multidisciplinary approach to guide in the selection and prioritization of high-quality cancer research studies. Please review the Disease Team Charter for details. For questions, contact Alyssa Garcia.

Team Leaders

Disease Team	Disease Team Leader	Disease Team Co-Leader
Early Phase Therapeutics	Deva Mehalingham, MD	Young Chae, MD
Hem - Leukemia	Jessica Altman, MD	Olga Frankfurt, MD
Hem - LPDs	Barbara Pro, MD	Leo Gordon, MD
Hem - MPNs	Brady Stein, MD	N/A
Hem - Transplant	Jayesh Mehta, MD	Kehinde Adekola, MD
TRIST - Skin	Jeffrey Sosman, MD	Sunandana Chandra, MD
TRIST - Lung	Malcolm DeCamp, MD	Nisha Mohindra, MD
TRIST - Head & Neck	Sandeep Samant, MD	Bharat Mittal, MD
TRIST - GI	Mary Mulcahy, MD	David Bentrem, MD
TRIST - GU	Maha Hussain, MD	Edward Schaeffer, MD
TRIST - Neuro-oncology	Priya Kumthekar, MD	Orin Bloch, MD
TRIST - Sarcoma	Mark Agulnik, MD	Jeffrey Wayne, MD
WC - Breast	William Gradishar, MD	Massimo Cristofanilli, MD
WC - Gynecological	Shohreh Shahabi, MD	Daniela Matei, MD

Documents

Disease Team Charter

Study Review Endorsement Form

Supplemental Clinical Trial Review Form

Evaluates all cancer-relevant research protocols, including the review of all protocol amendments. Please see the SRC Charter for more details.

Members

Name	Specialty	Status
Kehinde Adekola, MD Core Member	Hematologic Malignancies	Voting Member
Mark Agulnik, MD Member	Medical Oncology	Voting Member
Jessica Altman, MD Alternate Member	Hematologic Malignancies	Voting Member
Al Benson III, MD Chair	Medical Oncology	Voting Member
Eric Donnelly, MD Core Member	Radiation Oncology	Voting Member
Pedram Gerami, MD Core Member	Dermatology	Voting Member
Borko Jovanovic, PhD Core Member	Biostatistics	Voting Member
Masha Kocherginsky, PhD Alternate Member	Biostatistics	Voting Member
Robert Lewandowski, MD Core Member	Radiology	Voting Member
Daniela Matei, MD Core Member	Gynecological Oncology	Voting Member
Maria Matsangou, MD Member	Medicine-Hematology/Oncology	Voting Member
Joshua Meeks, MD Alternate Member	Translational Research, Urology	Voting Member
John Nielsen, MD Scientific Review Coordinator
David Odell, MD, MMSc	Thoracic Surgery	Voting Member
Carolyn Passaglia, CCRP	Clinical Research Operations
Tim Pearman, PhD Alternate Member	Cancer Control and Survivorship	Voting Member
Barbara Pro, MD Core Member	Hematologic Malingancies	Voting Member
Alfred Rademaker, PhD Co-Chair	Biostatistics	Voting Member
Renee Riphenburg Webb, MA, CCRC	Research Administration
Sally Scherer, CCRA	Interim Associate Director, Research Oversight System
Jonathan Strauss, MD Core Member	Radiation Oncology	Voting Member
Victoria Villafor, MD Core Member	Medical Oncology	Voting Member
David Walterhouse, MD	Pediatric Oncology	Voting Member
Amy Walz, MD Core Member	Pediatric Oncology	Voting Member
Tony Yang, MD Core Member	Translational Research in Solid Tumors	Voting Member
Susan Yount, MD Core Member	Cancer Control and Survivorship	Voting Member

Rotating Pharmacy Representatives

Colleen Czerniak, PharmD
Marina Grishchenko, PharmD
Kathryn O'Brien, PharmD
Soniya Tambe, PharmD

Rotating Pathology Representatives

Elena Aristide, CCRP
Lauren Nielsen

Documents

2017 Meeting Schedule

2018 Meeting Schedule

SRC Charter

Guidance on SRC Review Requirements

Accrual Policy

Data and Safety Monitoring Plan

No Waiver Policy

Trial Activation Diagram

Research Oversight Interactions Diagram

Reviewer Forms

Responsible for data and safety monitoring, monitoring of protocol compliance.

Members

Name	Specialty	Status
Al B. Benson, III, MD, FACP, FASCO Member		Voting Member
Sonali Chaudhury, MD Co-Chair	Pediatric Hematology/Oncology	Voting Member
Olga Frankfurt, MD Chair	Hematology/Medical Oncology	Voting Member
Catherine Humphreys, MA, CCRC Member	Quality Assurance
Aparna Kalyan, MD Member	Developmental Therapeutics	Voting Member
Jason Kaplan, MD Member	Developmental Therapeutics	Voting Member
Nisha Mohindra, MD Member	Thoracic Oncology	Voting Member
Carolyn Passaglia, CCRP Member	Clinical Research Operations
Sally Scherer, CCRA Member	Quality Control/Quality Assurance
Denise Scholtens, PhD Member	Biostatistics	Voting Member
Mary Beth Tull, MS Member	Chemoprevention
Renee Webb, MA, CCRC Member	Cancer Center Administration
Jill Woodman, CCRP Member	Quality Assurance

Documents

Responsibilities

Administrative Guidelines & Processes

Publication Policies & Processes

Data Compliance Policies & Processes

Protocol Deviation Form

Serious Adverse Event (SAE) Form

Internal Data Compliance Policy

Participating Site Data Compliance Policy

Semi-Annual Report Template

Minimal/Moderate Semi-Annual Report

Responsible for the internal auditing program.

Members

Name	Specialty	Status
Jessica Altman, MD Chair	Hematologic Malignancies	Voting Member
Kehinde U.A. Adekola, MD Member	Hematologic Malignancies	Voting Member
Marina Grishchenko, BCPS, RPH, PhD Member	Pharmacy	Voting Member
Catherine Humphreys, MA, CCRC Member	Quality Assurance
Aparna Kalyan, MBBS Member	Developmental Therapeutics	Voting Member
Jason Kaplan, MD Member	Developmental Therapeutics	Voting Member
Sheetal M. Kircher, MD Member	Translational Research in Solid Tumors	Voting Member
Katherine McCarthy, CCRP Member	Quality Assurance
Carolyn Passaglia, CCRP Member	Clinical Research Operations
Mario Pineda, MD Member	Translational Research in Solid Tumors	Voting Member
Sally Scherer, CCRA Member	Quality Assurance/Quality Control
Renee Webb, MA, CCRC Member	Cancer Center Administration
Jill Woodman, CCRP Member	Quality Assurance

Documents

Corrective Action Plan Template & Guidelines

Internal Audit Report Template

To submit a cancer-relevant project to the SRC for approval, complete a protocol submission form in NOTIS. You can access NOTIS using yoru NET ID and password. Click "protocol submission forms" under the main menu. Questions about this process can be directed to John Nielsen at src.ccsg@northwestern.edu.

Documents

Letter of Intent Template (must be submitted for all interventional investigator-initiated trials prior to protocol submission)

Obtaining NOTIS Access (for sites that will not use NU IRB as their IRB of record)

IIT Templates (for assistance, contact Jennifer Kreutzer, Sabeeha Mukit or Emily Meyers)

The SRC receives and reviews revisions for projects that the committee initially approved. Revisions must include a summary of changes. All investigator-initiated studies, including those studies initiated by another site, must be SRC-approved prior to IRB submission. Industry-sponsored studies may be submitted to the SRC and IRB simultaneously. All revisions should be submitted to John Nielsen.

If the sponsor does not provide a summary of changes, please use template below.

Documents

Summary of Changes Template for Investigator-Initiated Studies

Research Oversight

Disease Teams

Team Leaders

Documents

Scientific Review Committee (SRC)

Members

Documents

Data and Safety Monitoring Committee (DSMC)

Members

Documents

Clinical Trial Audit Committee (CTAC)

Members

Documents

Initial Submissions

Documents

Revisions

Documents