Clinical Trial Resources

The MCW Cancer Center provides investigators with training and standardized resources and processes to ensure cancer clinical trials are conducted in a methodologically sound, safe, compliant, expedient, and cost‐effective manner.

Investigator Resources

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

New Trial Development
Brian Chung, PhD: (414) 805-7694 |

Trial Management and Resources
Ben George, MD, CTO Medical Director: (414) 805-4600|

Clinical Research Committees
Jennifer Bollmer, PhD: (414) 805-1947 |

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.


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.

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.

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.

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.
Adult site, profile glossary, IRB procedures
Administrative SOPs

SOP Process Change Management (Feb. 11, 2022) (PDF)

SOP on SOPs (Nov. 5, 2021) (PDF)

Study Selection
Study Setup

Protocol Implementation Meetings (March 16, 2020) (PDF)

Required Protocol Training (June 19, 2019) (PDF)

Study Conduct

Patient Screening and Enrollment (Nov. 5, 2021) (PDF)

Study Subject Unblinding (March 16, 2020) (PDF)

Ongoing Processes

Completing the FDA 1572, Financial Disclosures and CVs (Feb. 11, 2022) (PDF)

Consenting Study Subjects (Nov. 5, 2021) (PDF)

Documenting Delegation of Authority (Sept. 2, 2021) (PDF)

Employee Resignation (March 16, 2020) (PDF)

External Audits (Nov. 5, 2021) (PDF)

External Safety Reports: Cooperative Groups (Nov. 5, 2021) (PDF)

External Safety Reports: Industry Sponsored (Nov. 5, 2021) (PDF)

Internal Quality Assurance Reviews (June 10, 2020) (PDF)

Investigator Brochure Version Control (Nov. 5, 2021) (PDF)

Investigator Review of Subject Laboratory Reports (Nov. 5, 2021) (PDF)

Laboratory Processes (March 16, 2020) (PDF)

Planned Study Transition Between CTO Employees (Feb. 20, 2018) (PDF)

Study Monitors and Monitoring Visits (Aug. 15, 2023) (PDF)