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Human
Investigation Committee
Yale University
School of Medicine
47 College Street,
Suite 204
New Haven, CT
06520-8010 USA
Phone:
(203) 785-4688
Fax:
(203) 785-2847
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Forms, Templates, Checklists & Instructions
To view and print the following Adobe Acrobat PDF documents you will need Adobe Acrobat Reader. You may download a copy of this software, free of charge, from the ITS Web site.
Some forms are also available for downloading as Microsoft Word documents.
GENERAL INSTRUCTIONS:
How Many Copies |
Word | |||
MSWord Track Changes Instructions |
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FDA Certificate of Confidentiality Application Instructions |
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NIH Certificate of Confidentiality Application Instructions |
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HIC IRB Registration Letter |
New |
Protocol Application Form Instructions |
New | |||
Protocol Application Form |
Word | New | ||
Repository Application |
Word | |||
| Medical
Record Review Form |
Word | |||
Exemption Request |
Word | |||
Not Human Subjects Research Form |
Word | |||
Humanitarian Use Device Request |
Word | New |
REQUESTS FOR RENEWALS AND CLOSURE:
Instructions for Request to Reapprove a Research Study |
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Reapproval Request |
Word | ||
Closure Request |
Word |
AMENDMENTS:
Amendment to Change Principal Investigator |
Word | ||
Amendment to Add or Remove Investigator(s) and Study Personnel |
Word | ||
Amendment to Protocol or Associated Documents |
Word |
EMERGENCY USE, ADVERSE EVENTS AND DEVIATIONS:
Emergency Use Report |
Word | ||
Emergency Use Consent Form |
Word | ||
Report of Adverse Event(s) under Yale PI (Form 6A) |
Word | ||
Report of Adverse Event(s) under Non-Yale PI (Form 6B) |
Word | ||
Protocol Deviation/Unanticipated Problem Report Form |
Word | ||
Lost/Stolen Laptops Form |
Word |
OTHER:
| HIC Protocol-Related Conflict of Interest Disclosure Form |
Word | ||
Request for Permission to Serve as Principal Investigator on a Research Protocol Involving Human Subjects |
Word | ||
Collaborating Investigator Instructions |
Word | ||
Request for Permission to Serve as a Collaborating Investigator |
Word |
TISSUE AND SPECIMEN REQUESTS:
Yale New Haven Hospital Request for Excess Clinical Samples |
Website | ||
Cancer Data Repository (CaDR) |
Website |
Forms:
HIC Institutional Endorsement of Proposed Research Involving Human Subjects (Form 10) |
Word | New | ||
| Terms of the Federalwide Assurance Office for Human Research Protections (OHRP) Web site | ||||
Templates Templates are now available online and should |
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| Data and Safety Monitoring Template |
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Consent Forms: |
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Informed Consent Template |
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Informed Consent Template - Spanish Version |
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Compound Authorization Form |
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Child Assent Form Template |
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| Repository Consent Template
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Authorization for Donation
of Excess Tissue
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| Authorization and Advanced Directive
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| Consent Addendum
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Video/audio consent form |
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Short form written consent |
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| Short form written consent (Spanish)
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Checklists |
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| Informed Consent Checklist |
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| Checklist for Banking of Data and Biologics for Future Use |
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Last modified: Thursday, 22-Oct-2009 13:19:43 EDT (VM)