2010 IRB Forms
Note:
Please see System Requirements before using our forms.
Category
Fax Back #
Initial Submission
Submission Checklist
Writing A Research Protocol (Guide)
Informed Consent Document Template (US)
Informed Consent Document Template (CAN)
Assent Document Template
Sponsor/CRO New Study Submission Form
Sub-Study and/or Additional Research (Supplement)
Research Site Submission Form
Research Site Submission (Guide)
Research Site Submission (Supplement) - Investigator Initiated
Research Site Submission (Supplement) - Additional Sites
Research Site Submission (Supplement) - Research Experience, Ed, Training
Research Site Submission (Checklist) - Transfer of IRB Oversight
Non-IND/Device Studies Form
FDA 1572 Form
Qualified Investigator Undertaking Information Form (QIU)
Federally Funded Research/FWA Supplement
Investigator Conflict of Interest
Waiver of Informed Consent
Waiver of Documentation of Informed Consent
866-596-1535
Amendment Submission/Revised ICD
Protocol Amendment/Protocol Administrative Changes/Revised ICD Form
Extension/Sub-Study Compensation Form
866-657-7914
Study Status Report/Periodic/Continuing Review
Study Status Report Form ( Site Only )
Study Status Report Form for Investigator Initiated Studies
Study Status Report (Guide)
Protocol Continuing Review Form ( Sponsor/CRO Only )
Investigator Conflict of Interest
866-657-7917
Deviation/Non-Compliance
Non-Compliance with the Protocol, Board Requirements, or Regulations Report Form
Non-Compliance with the Protocol, Board Requirements, or Regulations (Guide)
866-377-7103
Unanticipated Problems Involving Risk
Unanticipated Problems Involving Risk to Human Subjects or Others Form
Unanticipated Problems Involving Risk to Human Subjects or Others Form (Guide)
866-377-7103
Recruitment/Study Related Materials
Recruitment/Study Related Materials Submission Form
Recruitment/Study Related Materials Submission Form (Supplement)
Recruitment/Study Related Materials (Guidance)
Phone Screen (Guidance)
866-657-7916
Product Safety/SAE
Product Safety Submission Form
866-657-7915
Institutional Deferral Letters
Hospital Deferral Letter
Hospital Procedure Letter
Nursing Home Letter
866-596-1535
Revised FDA 1572/NON-IND/Device/QIU
Revised FDA 1572[1572] or Revised Schulman Non-IND/Device Study Information Submission Form
Addendum to Revised 1572/QIU/Non-IND Form
Non-IND/Device Study Form
FDA 1572 Form
Qualified Investigator Undertaking Information Form (QIU)
Revised Qualified Investigator Undertaking Submission Form
866-657-7913
Translation
Guidance for Translations
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Educational References
Educational Resources
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California Bill of Rights
English Version
Spanish Version
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HIPAA Privacy Rule
Authorization Language
Alteration Or Waiver Of Authorization Request
Partial Waiver Of Authorization Request
866-596-1535
Additional Forms
Emergency Use Of A Test Article
Transfer of Study Subjects
Non-Coercion Addendum Request Form
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