AEs Home

All Principal Investigators will automatically have access to record Adverse Events (AE's) against their respective protocols.

If you are not a PI and require access to enter AE's, you must complete a Logon-ID Request Form:

Fax or mail form to:

The Office of Regulatory Affairs
University of Pennsylvania
133 S. 36th Street
Mezzanine Floor
Philadelphia, PA 19104-3246
Fax: 215/573-943

The overall purpose of the PennAEs system is to provide a reporting resource for faculty conducting research involving human subjects.
  1. Specifically this web-based reporting tool allows an investigator to report serious or non-serious, expected or unexpected adverse events or outcomes to the IRB in a timely fashion and receive written confirmation of the submission at the same time. more...
  1. A second function of the PennAEs adverse event system is to provide the investigator with an easy to use tool to record and track adverse events or expected problems or risks associated with a research project. more...
  1. Finally, the PennAEs system is designed to allow the clinical research investigator or sponsor-investigator to collect and store the entire range of data required to report to or as, a sponsor on serious adverse drug or device events. more..
Download Documents
   
and Useful Links

How to Log On

Adverse Event (AE)
    Main Page

Creating New AE's: IRB
    Required Elements

Optional Reporting
    Elements: Descriptions

Optional Reporting
    Elements: Reporter Info

Mfr., Drug, Device, and
    Facility Info

Confirmation

Find a Specific AE

List all AE's

Modify an Existing AE

Penn Form

Voluntary Notice to
    Sponsor Form

Requesting Reports

For help, email:
pennaes@pobox.upenn.edu
Copyright © 2002
University of Pennsylvania
Phone: 215-898-5000
3451 Walnut Street
Philadelphia, PA 19104