Request a "For Cause" Audit

Anyone can request an audit; the audit must be authorized before it is initiated.

If you have an allegation or complaint regarding non-compliant or unsafe conduct of a study involving human research participants contact the Human Research Protections Program Director, Assistant Dean for Clinical Research or the Quality Improvement Manager.

Director, Human Research Protections Program

Assistant Dean for Clinical Research

David C. Clark, PhD
Phone: 955-8422
Email: dclark@mcw.edu

Manager, Quality Improvement

Roxanne Pritchard, RN, BSN
Phone: 955-8844
Email: rpritcha@mcw.edu

 

 Process for requested "For Cause" Audit
  • If you have an allegation or complaint regarding non-compliant or unsafe conduct of a study involving human research participants contact the Human Research Protections Program Director, Assistant Dean for Clinical Research dclark@mcw.edu or the Quality Improvement Manager rpritcha@mcw.edu.
  • The allegation/complaint may be written or verbal, filed anonymously or associated with the reporter’s name.
  • The received allegation/complaint and associated information will be reviewed and appropriate measures will be taken.
  • The request for audit must be authorized.
  • The Quality Improvement staff initiates the conduct of the “For Cause” audit upon receipt of authorization.
  • The individual who filed the allegation/complaint will be notified of the plan to proceed with the “For Cause” audit, except in the event of an anonymously filed complaint/grievance.
 When to consider requesting a "For Cause" audit

Reasons for initiating a request for a “For Cause” audit may include but are not limited to the following:

  • Study conducted outside of principal investigator’s expertise.
  • Conflict of interest poorly managed or not managed.
  • Study was previously audited with plan/recommendation for re-audit.
  • Study not conducted in accordance with IRB approved protocol, investigational plan institutional policies, and/or federal regulations. Examples include but are not limited to the following:
    • Enrollment of ineligible individuals
    • Randomization errors
    • Serious adverse events not reported
    • Incorrect use of product
    • Protocol deviation

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