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Academic Health Centers

The following tools are available to assist researchers in the Penn medical community. Please be aware of the terms and conditions stated below.

Informed Consent Template
Penn has developed a template to aid in the construction of a research subject informed consent form. This standard form flows logically from a research subject perspective, and is designed to ensure all required elements of informed consent are captured as well as to improve the ease of IRB review.

Protocol Design Template
The protocol is a document that describes the objectives, design, methodology, statistical considerations, and organization of a research study. The protocol explains the specific procedures of the study and outlines the scientific, organizational, administrative, and financial aspects of the research study.

Investigational New Drug (IND) Decision Resource Site
Not sure whether or not you need to file an IND to conduct your study? Think your study might be exempt? Visit IND Research, OHR's website dedicated to assisting researchers with the IND decision process.
Regulatory Binder Template
The Reg Binder template provides a format for structuring the Regulatory Binder (AKA Essential Documents File), and guidance for what regulatory documents should be filed in each section. Sample templates for logs are also available for download to use with the template.

By using this site, you agree that:
•  The University of Pennsylvania is not responsible for any error or mission in the information at this site or in an informed consent document. However, if you discover what you think is an error or omission at this site, we would appreciate it if you would email us at ocr@exchange.upenn.edu.
•  You are responsible for complying with all applicable laws and University policies when using information posted on this website. For example, an IRB may require you to add or change any of the language you may find on this site, depending upon the particular facts and circumstances regarding your proposed study.
•  The University of Pennsylvania is not responsible to you, or to any third party, for any claim or damage that may occur as a result of your use of information at this site.