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IRB Library

The IRB Library houses submission documents, guidance, and policies for the research community to access and download.

  • Forms - IRB application documents
  • Templates - sample documents for an IRB submission
  • Guidance - information on important topics such as FERPA and data security
  • Policies - standard operating procedures (SOPs) for the review of human subjects research
  • PAM - post approval monitoring, documents to assist researchers with ongoing monitoring of research
Document Category Document File Document Description Version Date
Forms Microsoft Office document icon Amendment Application Request changes to IRB approved documents or change in PI 08/04/2017
Forms Microsoft Office document icon Amendment Application Project Team Request addition or removal of project team members 08/13/2015
Forms Microsoft Office document icon Closure Application Request study closure 08/04/2017
Forms Microsoft Office document icon Continuing Review Application Request continuing review of active study 08/04/2017
Forms Microsoft Office document icon Deferred Projects Annual Report Provide status update of study deferred to external IRB 08/04/2017
Forms Microsoft Office document icon Device Form Provide information related to use of an investigational device 04/27/2016
Forms Microsoft Office document icon Event Report Provide information related to adverse event or unanticipated problem 08/04/2017
Forms Microsoft Office document icon HIPAA Waiver Request Request a waiver of HIPAA Authorization 06/12/2017
Forms Microsoft Office document icon Request an exception to PI Eligibility policy Request an exception to PI Eligibility policy 08/08/2017
Forms Microsoft Office document icon Project Team Form Provide list of study team members and associated role 02/17/2014
Forms Microsoft Office document icon Project Information Form Provide information on a new study 05/01/2016
Forms Microsoft Office document icon Protocol Deviations Report Provide information on protocol deviations that occurred since last review 09/16/2015
Forms File Request for External IRB Review Request for deferral of oversight to external IRB 06/09/2016
Forms Microsoft Office document icon Scientific Validity Review Form Provide documentation of review of scientific validity 04/24/2017
Forms File Self-Assessment Tool Conduct and document a self-audit 02/04/2016
Forms Microsoft Office document icon Translation Certification Form Certify the qualifications of the translator used for study documents 12/02/2015