Titlesort descending Description Date
PI Compliance Assessment Form (PICA) The PICA should be used to develop a Monitoring Summary which is required at the time of continuing review for certain studies. The PICA is a form controlled by OCR and should be filed in the regulatory binder - not attached to IRB submissions. Aug 26, 2016
Prime Grant Continuing Review Form This is the most recent version of the Prime Grant continuing review form. Please note that this form should only be used for Umbrella or Prime Grants under IRB purview. Nov 13, 2017
Principal Investigator Assurance For IRB Reliance Agreements where Penn must rely on an external IRB, the PI must sign and include this form with the reliance agreement submission. Nov 13, 2017
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. Nov 13, 2017
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 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 - 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 - 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
Quality Improvement Project Application See the Guidance tab for more information about Quality Improvement projects. Aug 26, 2016
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. Nov 13, 2017