Forms and Templates

General IRB Forms

Agreement of Investigator Responsibilities (DOC)
This must be submitted whenever there is a change in Principal Investigator

Attestation for Ceded Reviews & Projects (DOCX)
This attestation should be completed by the investigator in the process of requesting a ceded review or in the establishment of a reliance agreement of IRB review.

Back-Translator Declaration Form (DOCX)
Required documents when Investigators submit translated & back-translated documents to the IRB for review

De-identified Data Agreement (DOC)
Model letter to include in IRB submissions when receiving or providing de-identified samples to/from other institutions

Electronic Copy Certification for paper Informed Consents (DOCX)
For projects which seek to archive paper informed consents electronically in accordance IRB SOP: Research Consent Storage: Electronic Copies of Paper Informed Consent Forms.

Investigator Reliance Request Form (DOCX)
Use this form to request a coordinated or single IRB review when a study may involve 2 or more institutions

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

IND Exemption Form for Investigators (DOC)
An attestation when IND is not required for use of a drug with a clinical trial

In-vitro Diagnostic (IVD) Device Research Attestation (DOCX)
An attestation to confirm that the proposed research involving an IVD device meets the criteria as outlined in FDA guidance for approval without the requirements of informed consent.

Protocol Deviation Summary Report Template (DOC)
A template for study teams to use when reporting protocol deviations at the time of continuing progress report

Public Data Set Nomination Checklist (DOCX)
An application to nominate new data sets to be determined as publicly available by the MCW/FH HRPP office

Translator Declaration Form (DOCX)
Required documents when Investigators submit translated documents to the IRB for review

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.

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.


HRPP Contact Information

(414) 955-8422
(414) 955-6575 (fax) (for general IRB questions) (questions about reliance agreements/deferral requests)

Location:  MFRC 3040
MACC Fund Research Center

Office of Research
8701 Watertown Plank Road
Milwaukee, WI 53226-0509

HRPP Staff Contact Info

HRPP Organizational Chart

Accreditation of Human Research Protection Programs, Inc. (AAHRPP)