Titlesort descending Description Date
Participating Site Addition Form This form should be completed when the Penn IRB will be serving as the Central IRB of Record for a multi site study. Please refer to the "How to Submit: Reliance Agreements" page of this website for full information about requirements for adding new sites under Penn IRB review. Apr 10, 2017
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. Apr 20, 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. Feb 16, 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. Feb 16, 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