Northwestern University Feinberg School of Medicine
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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 Ashlee Drawz.

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, Samantha Skinner, or Wendy Swetzig Dhiman, Christine Thacker)

 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 Dore

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

Jyoti Patel, MD

TRIST - Head & Neck

Sandeep Samant, MD

Michelle Gentile, MD

TRIST - GI

Aparna Kalyan, MD

Mary Mulcahy, MD

TRIST - GU

Maha Hussain, MD

Edward Schaeffer, MD

TRIST - Neuro-oncology

Priya Kumthekar, MD

Matthew Tate, MD

TRIST - Sarcoma

Jeffrey Wayne, MD

TRIST - Breast

Massimo Cristofanilli, MD

William Gradishar, MD

TRIST - Gynecological

Edward Tanner III, MD

Daniela Matei, MD

Documents

Disease Team Charter

Study Review Endorsement 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.

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)
Priya Kumthekar, MD Co-Chair, Associate Professor Neuro-Oncology & Hematology/Medical Oncology


Voting Members

Name Academic Rank Discipline Disease Team
Kehinde Adekola, MD Associate Professor Hematology/Medical Oncology Transplant
Al Benson, III, MD, FACSO Chair, Professor Hematology/Medical Oncology GI
Joan Chmiel, PhD Professor Preventive Medicine (Biostatistics)
Eric Donnelly, MD Associate Professor Radiation Oncology Breast, LPDs
Reggie Duerst, MD Associate Professor Pediatrics (Hematology, Oncology, and Stem Cell Transplantation
Borko Jovanovic, PhD Associate Professor Preventive Medicine (Biostatistics)
Masha Kocherginsky, PhD Co-Chair, Professor Preventive Medicine (Biostatistics)
Priya Kumthekar, MD Co-Chair, Associate Professor Neuro-Oncology & Hematology/Medical Oncology Neuro
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
Lauren Nielsen Clinical Operations Manager Pathology
David Odell, MD, MMSc Associate Professor Surgery (Thoracic Surgery) Lung
Barbara Pro, MD Professor Hematology/Medical Oncology LPDs
Ashley Ross, MD Associate Professor Urology GU
Jeffrey Sosman, MD Professor Hematology/Medical Oncology Skin
Jonathan Strauss, MD  Associate Professor Radiation Oncology Breast, Gyne
Roger Stupp, MD Professor Neurological Surgery; Hematology/Medical Oncology, Neurology (Neuro-Oncology) Neuro
David VanderWeele, MD, PhD Assistant Professor Hematology/Medical Oncology GU
Rotating Pharmacy Representative Research Pharmacist Pharmacy


Administrative, Non-Voting Members

Name Discipline Disease Team
Alyssa Dore Protocol Development Breast, Early Phase Therapeutics, GU, Leukemia, MPNs, Neuro, Transplant
Ashlee Drawz, MSRC Research Oversight and Compliance
Lauren Nielsen Pathology
Carolyn Passaglia, MSRC Clinical Trials Administration

Documents

SRC Charter

SRC Meeting Dates

Guidance on SRC Review Requirements

Accrual Policy

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
Michelle Gentile, MD, PhD Assistant Professor Radiation Oncology Head & Neck
Aparna Kalyan, MD Assistant Professor Hematology/Medical Oncology EPT, GI
Nisha Mohindra, MD Assistant Professor Hematology/Medical Oncology Lung
Alicia Morgans, MD Associate Professor Hematology/Medical Oncology GU
Hui Zhang, 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
Leanne Fountas, MPH, CCRC Quality Assurance Operations Manager 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
Zuoli Zhang, MS, CCRP Quality Assurance Monitor Quality Assurance
Kelly Benante, MPH, CCRP Senior Project Administrator - Chemoprevention Chemoprevention Administration
Tia Schering, MPH Quality Assurance Monitor - Chemoprevention Quality Assurance Chemoprevention
   

Documents

Data and Safety Monitoring Plan

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 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
Sean Sachdev, MD Assistant Professor Radiation Oncology GU, Neurology
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
Ashlee Drawz, MSRC, CCRC Director, Research Oversight & Compliance Clinical Trials Administration
Patricia Kartcheske Clinical Operations Manager Clinical Trials Administration
Anne Cerney, RN, BSN Clinical Operations Manager Clinical Trials
Administration including
Lake Forest Hospital
Leanne Fountas, MPH, CCRC Quality Assurance Operations Manager Quality Assurance
Rachel Lukas, CCRC Quality Assurance Monitor Quality Assurance
Jade Lieu, MHI Quality Assurance Monitor Quality Assurance
Brett Palmer, CCRC Quality Assurance Monitor Quality Assurance
Jill Woodman, CCRP Quality Assurance Monitor Quality Assurance
Zuoli Zhang, CCRP Quality Assurance Monitor Quality Assurance
Margaret Nevins, MBA,
CCRP
Clinical Research Project Manager Clinical Trials
Administration
Lauren Weller, MSRC, CCRC Clinical Research Project Manager Clinical Trials
Administration

Documents

Corrective Action Plan Template & Guidelines

 

 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

Summary of Changes Template for Investigator-Initiated Studies

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