Clinical Trial Resources | MCW Cancer Center | Medical College of Wisconsin

OnCore Clinical Trials Management Physician ACCESS

Investigator Resources

Access these resources and contacts for assistance in conducting clinical trials.

New Trial Development
Brian Chung, PhD: (414) 805-7694 | bchung@mcw.edu

Trial Management and Resources
Ben George, MD, CTO Medical Director: (414) 805-4600| bgeorge@mcw.edu

Clinical Research Committees
Jennifer Bollmer, PhD: (414) 805-1947 | jbollmer@mcw.edu

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New Trial Development

IIT Steering Committee
The Investigator-Initiated Trial (IIT) Steering Committee provides support and mentorship to principal investigators in developing a concept into a full clinical trial protocol for submission to the Scientific Review Committee.

Resources

Clinical Trials Protocol Template (March 2021) (DOCX)
Concept Development Process (PDF)
Protocol Activation Process (PDF)
Scientific Review Committee New Trial Submission Form (PDF)

Clinical Research Committees

Disease-Oriented Teams
Sixteen integrated Disease-Oriented Teams are comprised of basic, translational, clinical, and population health scientists focused on specific organ/disease groups. Each group meets monthly to exchange ideas and evaluate their research portfolio (active and pending trials). Teams discuss the feasibility and merit of new concepts and protocols proposed by members, as well as protocol prioritization.

Feasibility Committees
Adult trials are reviewed by the Feasibility Review Committee (FRC), to ensure new studies are rigorously vetted for patient population availability, competition with trials already in the portfolio, and operational resource utilization (personnel, financial, material). The FRC is charged with identifying any issue that may impact the success of a trial, making the Disease-Oriented Team aware of the issue, and helping to resolve the issue if possible. Pediatric trials are reviewed by the Pediatric Disease-Oriented Team which has a similar feasibility review function.

Adult Feasibility Review Committee Roster (PDF)
Pediatric Feasibility Review Committee Roster (PDF)
Feasibility Review Charter (PDF)

Scientific Review Committee
Comprised of members from a range of disease groups and modalities, as well as representatives from basic science, nursing, biostatistics, pharmacy, and the community, the Scientific Review Committee (SRC) plays a vital role in protocol review and monitoring to ensure trials are scientifically sound and that approved trials maintain patient accrual goals and scientific progress.

Scientific Review Committee Roster (PDF)
Scientific Review Committee Charter (PDF)

Data and Safety Monitoring Committee
The Data and Safety Monitoring Committee (DSMC) reviews trials for data quality and patient safety and focuses solely on MCW Cancer Center investigator-initiated interventional trials.

Data and Safety Monitoring Committee Roster (PDF)
Data and Safety Monitoring Plan (PDF)

Clinical Research Executive Committee
The Clinical Research Executive Committee provides a forum for senior clinical research faculty and administrative leaders to discuss and resolve issues related to the conduct and support of clinical trials at the Medical College of Wisconsin Cancer Center.

Standard Operating Procedures

Standard Operating Procedures (SOPs) help ensure consistency and compliance with Federal and State regulations, institutional policies, and Good Clinical Practice guidelines common to clinical research of all types.

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Adult site, profile glossary, IRB procedures

Adult Site Profile

Glossary of Terms and Definitions (Apr. 10, 2015) (PDF)

IRB Policies and Procedures

Investigational Drug Service Policies and SOPs

Clinical Research, Investigational Drug Policy (PDF)

Formulary Management of Biosimilars (PDF)

Investigational Drug Accountability and Inventory Management (PDF)

Investigational Drug Disposition and Destruction Policy (PDF)

Investigational Drug Record Retention (PDF)

Investigational Drug Temperature Monitoring Temperature Exclusion Policy (PDF)