Research Oversight

The Lurie Cancer Center provides oversight of all aspects of clinical research through several committees. These committees work collaboratively in this effort to provide comprehensive and robust review and monitoring oversight.

Disease Teams

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 Mehalingam, 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	Ankit Bharat, 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	Matthew Tate, MD
TRIST - Sarcoma	Mark Agulnik, MD	Jeffrey Wayne, MD
WC - Breast	Massimo Cristofanilli, MD	William Gradishar, MD
WC - Gynecological	Edward Tanner III, MD	Daniela Matei, MD

Documents

Disease Team Charter

Study Review Endorsement Form

Supplemental Clinical Trial Review Form

Scientific Review Committee (SRC)

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	Hematologic Malignancies	Voting Member
Al Benson III, MD Chair	Medical Oncology	Voting Member
Shira Dinner, MD	Medicine-Hematology/Oncology	Voting Member
Eric Donnelly, MD	Radiation Oncology	Voting Member
Reggie Duerst, MD	Pediatric Oncology	Voting Member
Borko Jovanovic, PhD	Biostatistics	Voting Member
Masha Kocherginsky, PhD Co-Chair	Biostatistics	Voting Member
Robert Lewandowski, MD	Radiology	Voting Member
Maria Matsangou, MD	Medicine-Hematology/Oncology	Voting Member
David Odell, MD, MMSc	Thoracic Surgery	Voting Member
Carolyn Passaglia, CCRP	Clinical Research Operations
Barbara Pro, MD	Hematologic Malingancies	Voting Member
Renee Riphenburg Webb, MA, CCRC	Research Administration
Jonathan Strauss, MD	Radiation Oncology	Voting Member
Roger Stupp, MD	Neurological Surgery	Voting Member
David VanderWeele, MD	Medicine-Hematology/Oncology	Voting Member
Victoria Villafor, MD	Medical Oncology	Voting Member
David Walterhouse, MD	Pediatric Oncology	Voting Member
Amy Walz, MD	Pediatric Oncology	Voting Member
Susan Yount, MD	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

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

Data and Safety Monitoring Committee (DSMC)

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

Leadership

Name	Academic Rank	Discipline	Disease Team
Olga Frankfurt, MD	Chair, Associate Professor	Hematology/Medical Oncology	Leukemia, MPNs, Transplant
Sonali Chaudhury, MD	Co-Chair, Associate Professor	Pediatric Hematology/Medical Oncology

Voting Members

Name	Academic Rank	Discipline	Disease Team
Al Benson, III, MD, FASCO	Professor	Hematology/Medical Oncology	EPT, GI
Sonali Chaudhury, MD	Associate Professor	Pediatric Hematology/Medical Oncology	--
Olga Frankfurt, MD	Associate Professor	Hematology/Medical Oncology	Leukemia, MPNs, Transplant
Aparna Kalyan, MD	Assistant Professor	Hematology/Medical Oncology	EPT, GI
Timothy Kruser, MD	Assistant Professor	Radiation Oncology	GU, Lung, Neuro, Skin
Nisha Mohindra, MD	Assistant Professor	Hematology/Medical Oncology	EPT, Lung
Alicia Morgans, MD	Associate Professor	Hematology/Medical Oncology	GU
Denise Scholtens, PhD	Professor	Preventive Medicine (Biostatistics) and Neurological Surgery
Krista Carlson, PharmD	Research Pharmacist	Pharmacy

Administrative, Non-Voting Members

Name	Title	Discipline
Carolyn Passaglia, CCRP	Administrative Director, Clinical Trials	Clinical Trials Administration
Catherine Humphreys, MA, CCRC	Senior Program Administrator	Multi-Site Research
Leanne Fountas, MPH, CCRC	Quality Assurance Monitor Team Lead	Quality Assurance
Minaz Cattan, MD	Quality Assurance Monitor	Quality Assurance
Rachel Lukas, CCRC	Quality Assurance Monitor	Quality Assurance
Brett Palmer, CCRC	Quality Assurance Monitor	Quality Assurance
Sehar Paya, MPH	Quality Assurance Monitor	Quality Assurance
Jill Woodman, CCRP	Quality Assurance Monitor	Quality Assurance
Sally Wroblewski, CCRC	Quality Assurance Monitor	Quality Assurance	--
Mary Beth Tull	Senior Research Project Administrator	Quality Assurance - Chemoprevention
Kelly Benante	Quality Assurance Monitor - Chemoprevention	Quality Assurance - Chemoprevention
Adrian Segura	Quality Assurance Monitor - Chemoprevention	Quality Assurance - Chemoprevention

Documents

DSMC Data Release Policies & Processes

Quantitative Data Sciences Core (QDSC) Data Release Policy

Data Compliance Policies & Processes

Protocol Deviation Form

Serious Adverse Event (SAE) Form

Internal Data Compliance Policy

Participating Site Acknowledgement

Clinical Trial Audit Committee (CTAC)

Responsible for the internal auditing program.

Leadership

Name	Academic Rank	Discipline	Disease Team
Jessica Altman, MD	Chair, Associate Professor	Hematology/Medical Oncology	Leukemia
Priya Kumthekar, MD	Co-Chair, Assistant Professor	Hematology/Medical Oncology	Neurology
Renee Webb, MA, CCRC	Assistant Director, Research Administration	Research Administration	--

Voting Members

Name	Academic Rank	Discipline	Disease Team
Kehinde U.A. Adekola, MBBS	Assistant Professor	Hematology/Medical Oncology	Leukemia, Transplant
Jessica Altman, MD	Associate Professor	Hematology/Medical Oncology	Leukemia
Shira Dinner, MD	Assistant Professor	Hematology/Medical Oncology	Leukemia
Aparna Kalyan, MBBS	Assistant Professor	Hematology/Medical Oncology	EPT (Multi-Histology), GI
Sheetal Kircher, MD	Assistant Professor	Hematology/Medical Oncology	GI
Priya Kumthekar, MD	Assistant Professor	Hematology/Medical Oncology	Neurology
Nisha Mohindra, MD	Assistant Professor	Hematology/Medical Oncology	Lung
Marina Grishchenko, BCPS, RPH, PhD	Research Pharmacist	Pharmacy	--
Mary Golf, PharmD, BCOP	Pharmacy Manager	Pharmacy	--

Administrative, Non-Voting Members

Name	Academic Rank	Discipline
Renee Webb, MA, CCRC	Assistant Director, Research Administration	Research Administration
Carolyn Passaglia, CCRP	Administrative Director, Clinical Trials	Clinical Trials Administration
Catherine Humphreys, MA, CCRC	Senior Program Administrator	Multi-Site Research
Leanne Fountas, MPH, CCRC	Quality Assurance Monitor Team Lead	Quality Assurance
Minaz Cattan, MD	Quality Assurance Monitor	Quality Assurance
Rachel Lukas, CCRC	Quality Assurance Monitor	Quality Assurance
Brett Palmer, CCRC	Quality Assurance Monitor	Quality Assurance
Sehar Paya, MPH	Quality Assurance Monitor	Quality Assurance
Jill Woodman, CCRP	Quality Assurance Monitor	Quality Assurance
Sally Wroblewski, CCRC	Quality Assurance Monitor	Quality Assurance
Mary Beth Tull	Senior Research Project Administrator	Quality Assurance - Chemoprevention

Documents

Corrective Action Plan Template & Guidelines

Initial Submissions

To submit a cancer-relevant project to the SRC for approval, complete a protocol submission form in NOTIS. You can access NOTIS using your 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)

Revisions

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