Forms and Templates
All files are Microsoft Word documents with the exception of the eBridge SmartForms.
*indicates MCW network access required
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| Research Not Involving Human Subjects |
| Proposal Application for Research Activity Not Involving Human Subjects |
View the application for proposals for research activity that does not involve human subjects for submission to the MCW/FH IRB |
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| Magnetic Resonance Imaging (MRI) Committee Application |
| MRI Research Using Humans |
Required for MRI research involving human subjects to be reviewed by the MRI Safety Committee (MCW Network Access required)
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| Consent Forms |
eBridge for clinical consent AND
eBridge for behavioral/non-clinical consent |
Login to eBridge and click xxx for the consent builder |
| New Draft Consent Form Templates |
FAQs about the new consent forms and review or pilot the new consent forms |
| Cooperative Group Consent Checklist - ECOG |
Review checklist of allowable modifications to ECOG modifications on the cooperative group consent form |
| Cooperative Group Consent Checklist - NCI |
Review checklist of allowable modifications to a GOG, SWOG and CALGB informed consent template |
| Cooperative Group Consent Checklist - NSABP |
Review checklist of allowable modifications to a NSABP informed consent template |
| Health Information Data and/or Tissue Banking Consent Template |
Use this template for tissue, blood or data banking consent |
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Humanitarian Use Device (HUD) Protocol and Consent Form Guidelines*
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Use this form and guidelines to apply for IRB review before using an HUD at MCW/FMLH. The materials submitted for review should include the Protocol and Consent Form.
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Procedure
Short form consent in Spanish
Short form consent in Hmong
Short form consent in Russian
Short form consent-English Translations
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Non-English Speaking Subject Consent |
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| Full Committee New Submission |
| eBridge for Full Committee New Submission |
Login to eBridge and click on Create Study from the My Home page |
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NCI CIRB
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| Guidance, Policy and Forms for Use of National Cancer Institute (NCI) Central IRB (CIRB)* |
View process and policy for use of NCI CIRB at MCW/FH |
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| Expedited New Submission |
| eBridge for Expedited New Submission |
Login to eBridge and click on Create Study from the My Home page |
| Guidelines for Submitting New Studies |
View the process for submitting a new study |
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| Exempt New Submission |
| eBridge for Exempt New Submission |
Login to eBridge and click on Create Study from the My Home page |
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| Continuing Review |
| eBridge for a Continuing Progress Report |
Login to eBridge, locate your APPROVED study from My Home Page, and click on New Continuing Progress Report |
| Continuing Progress Report (CPR) - Paper Form |
Submit a paper Continuing Progress Report ONLY for studies that have been approved to continue in paper (long-term follow-up and data analysis) |
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Template for Protocol Deviation Summary Report
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Use this template to record a summary of experienced events (protocol deviations) not previously described in an IRB approved protocol |
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| Amendments |
eBridge for amendments
- Changes to protocol
- Unanticipated events
- Protocol deviations |
Login to eBridge, locate your APPROVED study from My Home page |
| Amendment Application Form |
Use this paper form ONLY if your study is still in paper format or for HUD study |
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| Authorizations |
| Authorization to Use or Disclose PHI in Research |
Obtain direct authorization to use or disclose PHI for screening purposes |
| Authorization to Use or Disclose PHI in Research (Large Print) |
Obtain direct authorization to use or disclose PHI for screening purposes |
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Request for Waiver of Authorization for PHI
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Obtain access to PHI for research on decedents |
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| Other Documents |
| Agreement of Investigator Responsibilities |
Use this paper form ONLY if there has been a change of Principal Investigator |
| IND Exemption Form for Investigators |
Use for studies that meet ALL three criteria specified on the form
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| Reportable Events |
For studies in PAPER ONLY.
Use this form to record reportable events |
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Updated Investigator Drug or Device Brochure Cover Form
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Use to submit updated/revised investigator brochures to the IRB |
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| eBridge SmartForm PDF Files |
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Electronic copies of the eBridge SmartForms
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The documents are for review purposes only, and will not be accepted in place of an electronic submission. |