Anatomic Pathology Services Form |
This form should be completed and submitted if the answer to the Anatomic Pathology question on the BIO page of your HSERA application is answered "YES" |
Sep 07, 2016 |
Assent Form (Template) |
Assent Form (Template) |
Oct 07, 2012 |
CHOP/Penn Cooperative Agreement Determination Form |
CHOP/Penn Cooperative Agreement Determination Form |
Feb 20, 2014 |
Clinical Lab Services Form |
This form should be completed and submitted if the answer to the Clinical Laboratory Services question on the BIO page of your HSERA application is answered "YES" |
Aug 31, 2016 |
Closure Form |
This is the most recent version of the study closure form. Please see the "How to Submit" page for Closures for additional guidance on closing your completed study with the IRB. |
Jul 21, 2020 |
Community Based Research |
Submit this form when your research involves conducting research procedures at community sites external to Penn (e.g.,public places,community centers,shelters,places of worship,etc.). A community site may be local to the Philadelphia area or it may be applicable to a community in a foreign country |
Feb 04, 2020 |
Concise Consent Summary Template |
In alignment with changes to the Common Rule, informed consent must begin with a focused presentation of key information. Please download this template which also includes guidance for how to appropriately develop a concise summary. |
May 15, 2019 |
Conflict of Interest Disclosure Template Language |
Conflict of Interest Disclosure Template Language |
Mar 01, 2012 |
Consent Template for Risks of Social Media |
This template should be used in development of Informed Consent forms for projects that involve the use of social media by subjects. Please note this is not the entire consent form -only the section related to social media risks. |
Aug 26, 2016 |
Continuing Review Form Standard |
This is the most recent version of the standard continuing review form. See the "How to Submit" page for Continuing Review for additional guidance on submitting this form for your study. |
Jun 10, 2020 |
Continuing Review Form – Single/Central IRB |
This form is part of the continuing review application only when Penn is serving as the Single/Central IRB of Record, for both Penn and External Sites. |
Sep 04, 2019 |
Continuing Review Relying Site Supplement |
This form is part of the continuing review application only when Penn is serving as the Central/Single IRB of Record for External Sites. |
Jul 22, 2020 |
Corrective and Preventative Action Plan (CAPA) Template |
Please use this document to prepare your response to audits required by the IRB. The finalized document should include all requested information for all issues or findings of the audit that require response. This should be submitted via a Deviation submission in HSERA for IRB consideration. |
Nov 13, 2017 |
Department of Defense Checklist |
This form should be completed and submitted with the Initial application for all studies that are funded by the Department of Defense. |
Nov 13, 2017 |
Department of Education Checklist |
This form should be completed and submitted with the Initial application for all studies that are funded by the Department of Education. |
Nov 13, 2017 |
Department of Energy Checklist |
This form should be completed and submitted with the Initial application for all studies that are funded by the Department of Energy. |
Nov 13, 2017 |
Department of Justice Checklist |
This form should be completed and submitted with the Initial application for all studies that are funded by the Department of Justice |
Nov 13, 2017 |
Deviation Form |
This is the most recent version of the Deviation Report form. Please see the "How to Submit" page for Deviations for additional guidance on reporting deviations to your approved protocol. |
Apr 04, 2019 |
Devices in Research |
Please submit this supplemental form if your research procedures involve the use of a device (e.g., an instrument, apparatus, implement, machine, contrivance, implant, assay, etc.). This form is required to be submitted if the study is not exempt from IDE regulations or if requested by IRB staff. |
Jun 09, 2020 |
Drugs in Research |
Please submit this supplemental form if your research procedures involve the use of Drugs, Biologics, Dietary Supplements, Foods, Food Additives, & Cosmetics AND you are requesting that the IRB make an IND exemption determination. |
May 29, 2018 |