FH/MCW Standard Operating Procedure (SOP)*(pdf) This document describes the requirements that both the IRB and clinical investigators must satisfy. Contents include IRB organization and approval criteria, informed consent requirements, and investigator responsibilities. The addendum below is also incorporated and includes the MCW/FH recruitment policy.
FH/MCW Standard Operating Procedure (SOP) - Addendum*(pdf)
You will need access to Infoscope, the Medical College of Wisconsin's Intranet, to view the policies below.
Medical College of Wisconsin Corporate Policies
Conflicts of Interest*
MRI Safety Committee
Gadolinium (MRI) Use in Human Research MCW MRI Safety Committee Policy*
Banking: Accumulating Health Care Data or Biospecimens for Future, Unspecified Research Purposes (pdf) The activity of collecting and storing data or biospecimens for future, unspecified research purposes is considered a "research activity" subject to IRB review and approval - independently of the IRB review/approval required for specific studies with the same data/biospecimens.
Required training for Bank Custodians & key personnel (on ANGEL website)
Case Report / Case Study (pdf) Definitions
Decreased Decisional Ability (pdf)
Definition of Human Subjects (pdf)
Definition Research (pdf) Definition
Eclipsed Progress Reporting Policy (pdf) Principal Investigators (PI) who fail to submit and obtain approval for a Continuing Progress Report (CPR) or fail to submit a Study Close-Out Report to the IRB prior to the study’s IRB approval expiration fail to comply with one of the PI’s primary responsibilities under federal regulation and MCW IRB policies.
Humanitarian Use Device (HUD) (pdf)
IRB Action Guidelines for HRPP and MCW/FH IRB (pdf)
Modifications to an Approved Protocol (pdf)
Use of National Cancer Institute Central IRB (pdf)
Protocol Deviations Policy
Reportable Events Policy
Research Involving Froedtert Emergency Department Resources (pdf)
Study Closure (pdf)
Submission, Review and Evaluation of National Cancer Institute Cooperative Group Consent Form (pdf)
Submission of Continuing Progress Reports (CPR) (pdf)
Submitting New Studies (pdf)
FDA IND or IDE Documentation Requirements (pdf)
Guidelines for Registering a Clinical Trial on ClinicalTrials.Gov (pdf)