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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.

 Initial Submissions

All cancer-relevant projects must be submitted in NOTIS using the electronic new protocol submission form (eNPSF). Your project will be routed for disease team review or acknowledgement (if appropriate) and then proceed to scientific review. You can access NOTIS using your NetID and password. Any questions about this process can be directed to src.ccsg@northwestern.edu.

For investigator-initiated projects, please use the templates below to complete a letter of intent (LOI) and/or your fully developed protocol. For assistance, please contact Samantha Skinner.

Documents

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

IIT Templates (for assistance, contact Sabeeha Mukit, Monika Stankiewicz,  Amaranthe Zinzani)

 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, please contact the PRMS team at src.ccsg@northwestern.edu.

Team Leaders

Disease Team Disease Team Leader

Early Phase Therapeutics

Devalingam Mehalingam, MD

Early Phase Therapeutics

Young Chae, MD

Hem - Leukemia

Jessica Altman, MD

Hem - Leukemia

Shira Dinner, MD

Hem - LPDs

Reem Karmali, MD

Hem - LPDs

Leo Gordon, MD

Hem - MPNs

Brady Stein, MD

Hem - MPNs

Jamile Shammo, MD

Hem - Transplant

Jayesh Mehta, MD

Hem - Transplant

Kehinde Adekola, MD

CSS-Pop Sci

Christine Rini, PhD

CP-Pop Sci

Brian Hitsman, PhD

TRIST - Skin

Jeffrey Sosman, MD

TRIST - Skin

Sunandana Chandra, MD

TRIST - Lung

Ankit Bharat, MD

TRIST - Lung

Jyoti Patel, MD

TRIST - Lung

Mohamed Abazeed, MD, PhD

TRIST - Head & Neck

Sandeep Samant, MD

TRIST - Head & Neck

Bharat Mittal, MD

TRIST - Head & Neck

Jochen Lorch, MD

TRIST - GI

Aparna Kalyan, MD

TRIST - GI

Mary Mulcahy, MD

TRIST - GU

David Vanderweele, MD, PhD

TRIST - GU

Edward Schaeffer, MD

TRIST - Neuro-oncology

Priya Kumthekar, MD

TRIST - Neuro-oncology

Matthew Tate, MD

TRIST - Sarcoma

Seth Pollack, MD

TRIST - Sarcoma

Jeffrey Wayne, MD

TRIST - Breast

William Gradishar, MD

TRIST - Breast

Eric Donnelly, MD

TRIST - Gynecological

Edward Tanner III, MD

TRIST - Gynecological

Daniela Matei, MD

Documents

 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.

Leadership

Name Academic Rank Discipline Disease Team
Al Benson, III, MD, FACSO Chair, Professor Hematology/Medical Oncology GI
Masha Kocherginsky, PhD Co-Chair, Professor Preventive Medicine (Biostatistics) n/a
Priya Kumthekar, MD Co-Chair, Associate Professor Neuro-Oncology & Hematology/Medical Oncology Neuro

Voting Members

Name Academic Rank Discipline Disease Team
Yasmin Abaza, MD Assistant Professor Hematology/Medical Oncology Leukemia
Kehinde Adekola, MD Associate Professor Hematology/Medical Oncology Transplant
Emma Barber, MD Assistant Professor Gynecologic Oncology Gyn-Onc
Al Benson, III, MD, FACSO Chair, Professor Hematology/Medical Oncology GI
Joan Chmiel, PhD Professor Preventive Medicine (Biostatistics) n/a
Eric Donnelly, MD Associate Professor Radiation Oncology Breast, LPDs, Gyn-Onc
William Funk, PhD Associate Professor Cancer Epidemiology and Prevention Pop Sci
Brian Hitsman, PhD Associate Professor Cancer Prevention Pop Sci
Masha Kocherginsky, PhD Co-Chair, Professor Preventive Medicine (Biostatistics) n/a
Priya Kumthekar, MD Co-Chair, Associate Professor Neuro-Oncology & Hematology/Medical Oncology Neuro
Jin-Shei Lai, PhD Professor Cancer Control & Survivorship Pop Sci
Adam Lin, MD, PhD Assistant Professor Hematology/Medical Oncology Transplant
Robert Lewandowski, MD Professor Radiology (Vascular and Interventional Radiology); Hematology/Oncology; Surgery GI
Devalingam Mahalingam, MD Co-Chair, Associate Professor Hematology/Medical Oncology Early Phase Therapeutics, GI
Xialei Mi, PhD Assistant Professor Preventative Medicine (Biostatistics) n/a
Eric Nesbitt, MD Healthy System Clinician Radiation Oncology H&N
David Odell, MD, MMSc Associate Professor Surgery (Thoracic Surgery) Lung
Christine Rini, PhD Professor Cancer Control & Survivorship Pop Sci
Dario Roque, MD Assistant Professor Gynecologic Oncology Gyn-Onc
Ashley Ross, MD Associate Professor Urology GU
Jenna Rossoff, MD Assistant Professor Pediatrics LCH
Ami Shah, MD Assistant Professor Hematology/Medical Oncology Breast
Jeffrey Sosman, MD Professor Hematology/Medical Oncology Skin, GU
Roger Stupp, MD Professor Neurological Surgery; Hematology/Medical Oncology, Neurology (Neuro-Oncology) Neuro
David VanderWeele, MD, PhD Associate Professor Hematology/Medical Oncology GU
Rotating PCF Representative Clinical Operations Manager Pathology n/a
Rotating Pharmacy Representative Research Pharmacist Pharmacy n/a
Rotating QA Representative Quality Assurance Monitor Internal QA and Monitoring n/a

Administrative, Non-Voting Members

Name Discipline Disease Team
Ashlee Drawz, MSRC Research Oversight and Compliance n/a
Stephanie Hynes PRMS Coordinator H&N, sarcoma, GU, EPT, neuro, skin, gyn-onc
Carolyn Passaglia, MSRC Clinical Trials Administration n/a
Samantha Skinner PRMS Operations Manager Pop Sci
Mateo Solis Rueda PRMS Coordinator leukemia, LPDs, transplant, breast, lung, GI, MPNs)
Erica Chant PRMS Project Manager neuro, skin, LPD, breast

SRC meeting dates are typically the first Wednesday and the third Thursday of each month, with submission deadlines one week prior.

Documents

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
Jochen Lorch, MD Chair, Professor Hematology/Medical Oncology Head & Neck
Sonali Chaudhury, MD Co-Chair, Associate Professor Pediatric Hematology/Medical Oncology

Voting Members

Name Academic Rank Discipline Disease Team
Sonali Chaudhury, MD Associate Professor Pediatric Hematology/Medical Oncology --
Laila Gharzai, MD Assistant Professor Radiation Oncology, Medical Social Sciences
Aparna Kalyan, MD Assistant Professor Hematology/Medical Oncology EPT, GI
Jochen Lorch, MD  Professor Hematology/Medical Oncology Head & Neck
Sean Sachdev, MD Assistant Professor Radiation Oncology GU, Neuro
Angela Waanders, MD, MPH Associate Professor Pediatric Hematology/Medical Oncology
Hui Zhang, PhD Professor Preventive Medicine (Biostatistics) and Neurological Surgery  

Administrative, Non-Voting Members

Name Title Discipline
Al Benson, III, MD FACP, FACCC, FASCO Professor
Associate Director for Cooperative Groups
SRC/DSMC Liaison		 Hematology/Medical Oncology
Devalingam Mahalingam, MD, PhD Professor
Director, Clinical Trials Office - Lurie Cancer Center
Director, Developmental Therapeutics (DT) and DT Fellowship Program		 Hematology/Medical Oncology
Maha Hussain, MD, FACP, FASCO Professor
Deputy Director,
Robert H. Lurie Comprehensive Cancer Center		 Hematology/Medical Oncology
Carolyn Passaglia, CCRP Administrative Director, Clinical Trials Clinical Trials Administration
Ashlee Drawz, MSRC, CCRC Director, Research Compliance and Integrity Clinical Trials Administration
Patricia Kartcheske Director, Clinical Operations Central Region Clinical Trials Administration
Jennifer Mitchell Director, Clinical Network Operations Clinical Trials Administration
Leanne Fountas, MPH, CCRC Lead Operations Manager, Study Startup & Quality Assurance Clinical Trials Administration
Jill Woodman, CCRP Quality Assurance Operations Manager Quality Assurance
Kelly Benante, MPH, CCRP Senior Project Administrator - Chemoprevention Chemoprevention Administration

Documents

 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
Sunandana Chandra, MD Co-Chair, Assistant Professor Hematology/Medical Oncology Skin

Voting Members

Name Academic Rank Discipline Disease Team
Jessica Altman, MD Associate Professor Hematology/Medical Oncology Leukemia
Sunandana Chandra, MD Assistant Professor Hematology/Medical Oncology Skin
Aparna Kalyan, MBBS Assistant Professor Hematology/Medical Oncology EPT (Multi-Histology), GI

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
Ashlee Drawz, MSRC, CCRC Director, Research Oversight & Compliance Clinical Trials Administration
Patricia Kartcheske Director, Clinical Operations Central Region Clinical Trials Administration
Jennifer Mitchell Director, Clinical Network Operations Clinical Trials
Administration
Leanne Fountas, MPH, CCRC Lead Operations Manager, Study Startup & Quality Assurance Quality Assurance
Jill Woodman, CCRP Quality Assurance Monitor Quality Assurance

Documents

 Revisions

All protocol revisions must receive SRC continuing review. Please submit your revision, including a summary of changes, using protocol activities in NOTIS. All investigator-initiated studies, including those initiated by another site, must be SRC approved prior to IRB submission. Industry-sponsored studies may be submitted to the SRC and IRB simultaneously. Please use the template below if the sponsor does not provide a summary of changes.

Documents