Protocol Design Template

The Protocol Design Template was developed by the Office of Human Research based on the ICH guidelines (ICH-E-6) and FDA regulations (21CFR50). The intention of the Protocol Design Template is to provide Investigators, Sponsor-Investigators, and Clinical Research Coordinators with a format and guidelines for developing Study Protocols that are compliant with Good Clinical Practice standards. The current template is designed to meet the needs of a drug study. Subsequent templates will address other investigational agents (e.g. vaccines, radiation, devices).
The template was last modified 3/5/2003.

Penn Version

For more information about developing the Informed Consent document, Penn faculty and staff should reference the Protocol Design section of the Penn Manual (PennKey required).

Protocol Design Template - with guidelines

• Open the Protocol Design Template with Guidelines (Word)
• Use File.. Save As.. to save the file on your computer.
• Use this template as a checklist to ensure that all required GCP elements of the protocol have been captured in your study consent form.
• Reference Tips for using the Protocol Design Template to learn how to use the automated table of contents feature.

Protocol Design Template - without guidelines

• Open the Protocol Design Template (Word)
• Use File.. Save As.. to save the file on your computer.
• Review the standard language text provided for certain sections, modify as necessary
• Complete all sections according to the guidelines outlined in the Penn Manual (Elements of a Protocol section of the Penn Manual)
• Reference Tips for using the Protocol Design Template to learn how to use the automated table of contents feature.

Also available to view is a sample Protocol using the template .

External Version

Protocol Design Template - with guidelines

• Open the Protocol Design Template
• Use File.. Save As.. to save the file on your computer.
• Use this template as a checklist to ensure that all required GCP elements of the protocol have been captured in your study consent form.
• Reference Tips for using the Protocol Design Template to learn how to use the automated table of contents feature.

The Protocol Design Template is copyright-protected © 2005 by the Trustees of the University of Pennsylvania. If your institution wishes to use the Protocol Design Template, please reference the University of Pennsylvania as the original source for the template.

If you have any questions or need additional assistance, feel free to contact the Office of Human Research at 215-746-7400 or ohr@mail.med.upenn.edu.