Titlesort ascending Description Date
Research Involving Children (Subpart D) Research Involving Children (Subpart D)- Complete and attach this form with your initial application if your study includes children. The IRB is required to make determinations about involvement of this population. Feb 20, 2014
Request for Waiver of HIPAA Authorization Request for Waiver of HIPAA Authorization Feb 27, 2014
Reportable Event Form (Non-Medical Event) This is the new Reportable Event form specifically for non-medical events. Please see the "How to Submit" page for reportable events for additional guidance. Apr 20, 2017
Reportable Event Form (Medical Event) This is the new Reportable Event form specifically for medical events. Please see the "How to Submit" page for reportable events for additional guidance. Apr 20, 2017
Quality Improvement Project Application See the Guidance tab for more information about Quality Improvement projects. Aug 26, 2016
Protocol Template - Social Behavioral This protocol template (developed by the Penn Office of Clinical Research) is designed to assist in the process of creating a social and behavioral sciences human research protocol May 31, 2016
Protocol Template - Retrospective Study This protocol template (developed by the Penn Office of Clinical Research) is designed to facilitate the creation of a retrospective clinical research protocol. May 31, 2016
Protocol Template - Propsective Study Design with no Investigational Product (IP) This protocol template (developed by the Penn Office of Clinical Research) is designed to facilitate the process of developing a clinical research protocol that does not involve an investigational product. E.g. Comparative effectiveness study, a cohort design, case control study, etc. May 31, 2016
Protocol Template - Clinical Trial This protocol template (developed by the Penn Office of Clinical research) is designed to help research teams develop a clinical trial protocol that includes an investigational intervention (drug, biologic, vaccine or device). May 31, 2016
Protocol Supplement for Requests to Rely on an External IRB This form is should be completed if you are asking the Penn IRB to rely on an External IRB through an IRB Authorization Agreement. It asks for specific details about the study that are necessary in order to ensure that the study adheres to the policies of Penn’s Human Research Protections Program. Feb 16, 2017