Human Research Protection Program

EmailEmail    |   Bookmark Page Bookmark  |   RSS Feeds RSS  |   Print Page Print  

Forms and Templates

General IRB Forms

Agreement of Investigator Responsibilities

This must be submitted whenever there is a change in Principal Investigator

Application for Activity that is Not Human Subjects Research

This application should be submitted for activity that is not research on human subjects

Back-Translator Declaration Form

Required documents when Investigators submit translated & back-translated documents to the IRB for review

Coordinated IRB Review Request Form

Use this form to request a coordinated or single IRB review when a study may involve 2 or more of the Southeastern Wisconsin CTSI institutions

De-identified Data Agreement

Model letter to include in IRB submissions when receiving or providing de-identified samples to/from other institutions

ICH-GCP E.6 Checklist for Investigators

An attestation to confirm Investigators and Sponsors are meeting specific ICH-GCP E.6 guidance for project.

IND Exemption Form for Investigators

An attestation when IND is not required for use of a drug with a clinical trial

Protocol Deviation Summary Report Template

A template for study teams to use when reporting protocol deviations at the time of continuing progress report

Public Data Set Nomination Checklist

An application to nominate new data sets to be determined as publicly available by the MCW/FH HRPP office

Translator Declaration Form

Required documents when Investigators submit translated documents to the IRB for review

Updated Investigator Brochure (drug or device) Cover Form (for paper studies only)

    

 

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.

 

webmaster@mcw.edu
© 2014 Medical College of Wisconsin
Page Updated 02/17/2014