Principal Investigator (PI) Status Policy and Request Form

Health Sciences IRBs Principal Investigator (PI) Signature Policy

Forms

• Submission Cover Sheet for Ongoing Studies
  
• Change of Protocol (for revisions to IRB-approved materials)
  • Full Review Change of Protocol
  • Expedited Change of Protocol
  • Investigator Drug Brochure (IDB) Change of Protocol
• Protocol Closure of Previously Approved Research
• Reportable Event Reporting
  • Adverse Event Reporting
  • Unanticipated Problems/Incident Reporting
  • Noncompliance Reporting Form
• NCI Central IRB Forms
• Other Forms
  • HIPAA: Preparatory to Research Activities
  • HIPAA: Data Use Agreement
  • Clinical and Translational Research Core (CTRC)

Initial Review Application

With the implementation of ARROW, many initial review forms are no longer available.  Please see the ARROW page for additional information.

Continuing Review

With the migration of existing studies in to ARROW, paper continuing review forms are no longer available.  Please log in to ARROW to locate your study and open a continuing review application.

Federal regulations require that ongoing research must be reviewed by the IRB at least once a year, except in the case of exempt research. Most protocols are approved for a period of one year, although an IRB may require a shorter review period.

Change of Protocol

All changes of protocol, except those needed to eliminate an apparent immediate hazard to subjects, require prior IRB approval before they can be implemented. A change in protocol can be submitted to the IRB by using the appropriate change of protocol form available below.

Adverse Events, Unanticipated Problems, and Other Incident Reporting

Click here for forms and guidance.

National Cancer Institute (NCI) Central IRB Approved Protocol

The University of Wisconsin-Madison has agreed to defer IRB review of some protocols to the National Cancer Institute Central IRB (CIRB). Currently, this agreement is in place only protocols approved by the NCI CIRB involving adults. Further information about this process is included below. Please note that even when the UW has deferred IRB review to the NCI CIRB, local adverse events, noncompliance, and unanticipated problems that occur on these protocols must still be reported to the Health Sciences IRB using the UW-Madison forms.

Other Forms

Protocol Closure of Previously Approved Research

• Guidance
• Download Protocol Closure Report

Agreement for the Use of Coded Specimens

Conflict of Interest Form (COI)

Request IRB Documents

• Instructions
• Download Request Form

HIPAA Forms and Guidance

• Data Use Agreement
• Planning a Project: Preparatory to Research Activities Guidance
• Certification for Activities Preparatory to Research Application

Clinical and Translational Research Core (CTRC) Forms