Medical College of Wisconsin
Medical College of Wisconsin Medical College of Wisconsin
Research Bench Lab
Research Training

MCW Study Start-Up

Information and determination guidance for whether a clinical trial can be successfully completed at MCW from IRB submission, safety committee review, grants review, and regulatory compliance.

***Submit Professional Billing: Use this form to submit a Human Research Charge Notification to Clinical Physician Services (CPS)***

Guidance for initiating a study

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MCW Investigator Agreement for IDE

Available for situations where Sponsor-Investigator did not generate and provide an Investigator Agreement to the FDA with their initial IDE submission. Provides additional assurance of intent to remain compliance with appropriate federal regulations governing IDE trials.

For additional support or requests for materials please contact Susan Mauermann in the Research Office.

Feasibility Process

For additional support or requests for materials please contact Susan Mauermann in the Research Office.

Budgets & Contracts Negotiations: Industry Sponsored

Provides tools representing the current knowledge, practices and standards for use when completing the Clinical Trial Agreement (CTA) and budget negotiation processes. Offers materials for internal documentation and tracking of the budget negotiation process. Internal documentation allows user to track details which are not meant to be shared with sponsors. 

For additional support or requests for materials please contact Susan Mauermann in the Research Office.

Tools for Use with Sponsors

Provides standardized explanations of how procedures and processes will occur at MCW. 

For additional support or requests for materials please contact Susan Mauermann in the Research Office.

Budget Negotiation

Offers materials for internal documentation and tracking of the budget negotiation process. Internal documentation allows user to track details which are not meant to be shared with sponsors. 

For additional support or requests for materials please contact Susan Mauermann in the Research Office.

Justification Documents

Offers standardized justification language to provide study sponsors in the budget negotiation process. 

For additional support or requests for materials please contact Susan Mauermann in the Research Office.

CTA Negotiation

For additional support or requests for materials please contact Susan Mauermann in the Research Office.

 

IRB & Safety Reviews

For additional support or requests for materials please contact Susan Mauermann in the Research Office.

Regulatory Documents

For additional support or requests for materials please contact Susan Mauermann in the Research Office.