Human Research Protection Program

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Forms and Templates

General IRB Forms

Agreement of Investigator Responsibilities (doc)

Application for Activity That Is Not Human Subjects Research (doc)

View the application for activity that is not research on human subjects for submission to the MCW/FH IRB

De-identified Data Agreement

Model letter to include in IRB submission, to be used when receiving de-identified samples from other institutions.

Banking Protocol Procedures Template

Questions/prompts used to describe the procedures that will be used to manage the bank consistent with the “MCW/Froedtert IRB Policy on Banking”, dated Nov. 12, 2008

IND Exemption Form for Investigators

Use for studies that meet ALL three criteria specified on the form

Template for Protocol Deviation Summary Report

Use this template to record a summary of experienced events (protocol deviations) not previously described in an IRB approved protocol

Updated Investigator Drug or Device Brochure Cover Form

Use to submit updated/revised investigator brochures to the IRB, to be used when receiving de-identified samples from other institutions.

Forms for National Cancer Institute Central IRB at MCW

Amendment Request for CIRB Facilitated Review

Use this form to request MCW/FH Facilitated Review of an NCI CIRB Protocol Amendment.

CPR Request for CIRB Facilitated Review – Long-Term Follow-up or Data Analysis

Use this form to request MCW/FH Facilitated Review of an NCI CIRB Protocol Continuing Progress Report (CPR) for studies that are in long-term follow-up or data analysis phases.

CPR Request for CIRB Facilitated Review – Active Studies

Use this form to request MCW/FH Facilitated Review of an NCI CIRB Protocol Continuing Progress Report (CPR) for studies that continue to enroll subjects and/or in which participants remain active in study procedures.

CIRB MCW/FH IRB Continuing Progress Report (CPR) Form

Use this form to submit a Continuing Progress Report (CPR) to the MCW/FH IRB for Facilitated Review of NCI CIRB Studies.

Request for MCW Oversight

Use this form to request a change in oversight of an NCI CIRB study to the MCW/FH IRB.

 

Forms from Other MCW Departments

eBridge SmartForm PDF files

Electronic copies of the eBridge SmartForms are now available in PDF format on the eBridge Support website. The smartform documents are for review purposes only, and will not be accepted in place of an electronic submission.

HIPAA Privacy Research Forms

Electronic versions of the Authorization to Use or Disclose Protected Health Information in Research and the corresponding MCW Corporate Policy are available on the MCW HIPAA website.

Safety Committee Forms

Electronic versions of all of the Safety Committee's Hazardous Agent Forms are available on the Safety & Environmental Health website.

 

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Page Updated 02/09/2010