Titlesort ascending Description Date
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
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
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
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
Modification Form This is the most recent version of the Modification Submission Form. Please see the "How to Submit" page for modifications for additional guidance on making changes to your already approved study. Apr 20, 2017
IRB Authorization Agreement (IAA) Form If the Penn IRB will serve as a Relying IRB or Reviewing IRB in a research study collaboration with another institution, this form must be completed by the PI and included with the submission. Feb 16, 2017
Informed Consent Form Template (Social and Behavioral Sciences Research) Informed Consent Form Template (Social and Behavioral Sciences Research) - This template version includes the new EMR language to align with the roll out of the Clinical Trials Management System. The new language is required starting March 1,2017 Jan 24, 2017
Informed Consent Form Template (Biomedical) Informed Consent Form Template (Biomedical) -This template version includes the new EMR language to align with the roll out of the Clinical Trials Management System. The new language is required starting March 1, 2017 Jan 24, 2017
Individual Investigator Agreement Form This form should be used when one person is an investigator on the study team, is not affiliated with Penn and is not affiliated with an FWA institution or the institution does not have an IRB through which a standard IRB Authorization Agreement can be executed. Aug 26, 2016
Human Subjects Research Determination Form To be used in conjuction with the guidance document "Is IRB Review Required" that can be found on the "How to Submit; Initital" page of this website, this form will help determine whether your project is human subjects research and whether IRB submission is required. Aug 29, 2016