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