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
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.
Safety Committee Forms - this link will take you to the Safety Committee general intranet pages and provides access to forms which may be required by the various MCW Safety Committees.
Electronic versions of all of the Safety Committee's Hazardous Agent Forms are available on the Safety & Environmental Health website.