Subject: Adverse Events Reporting System (PennAEs) Now Retired
To PennAEs users:

We are writing to make you aware that PennAEs, the University's web-based Human Subjects Adverse Events Reporting System, has been retired as of June 3rd, 2008. A new secure, web-based protocol application, called the Human Subjects Electronic Research Application (HS-ERA), was released to researchers at Penn and replaces PennAEs.

What is HS-ERA?
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HS-ERA allows the creation, submission, electronic routing, and approval of Human Subject Protocols to the Institutional Review Boards (IRB), including the ability to submit Continuing Reviews, Unanticipated Problems, and Modifications to an existing Human Subjects Protocol created within the HS-ERA system. Also included is the ability to report Unanticipated Problems for protocols that were submitted on paper. Release 1.0 includes electronic notifications to internal review entities and the ability for the IRB member to review protocols.

Adverse Events functionality in HS-ERA
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HS-ERA incorporates the capability to report unanticipated problems posing risk to human subjects including reportable adverse events. Users are able to report unanticipated problems both for protocols created in HS-ERA or for those currently existing in the PennERA system.

Access & reporting
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To access the application and report an unanticipated problem, including a reportable adverse event:

1. With a web browser, go to https://medley.isc-seo.upenn.edu/hsProtocol/jsp/fast.do.
2. Authenticate with your PennKey and PennKey password.

Note: If you do not have a PennKey, or if you have a PennKey but forgot your password, go to the PennKey web site for more information at http://www.upenn.edu/computing/pennkey/. If you have any trouble with the PennKey process, contact your Local Support Provider. For a contact list, go to http://www.upenn.edu/computing/view/support/.

3. The Human Subjects Electronic Research Application (HS-ERA) home page will appear.
4. To report an unanticipated problem, select "Create" under "My submissions" in the left toolbar, and then select "Unanticipated Problem" on the Protocol Submission Type page.
5. Select a protocol from the list, or if a protocol is not listed, enter the protocol number to retrieve it from the PennERA system.

End-user support
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A support system is in place for HS-ERA users; information is on the PennERA web site at http://project.pennera.upenn.edu/help.asp.

Reference materials available
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HS-ERA reference materials, including Frequently Asked Questions (FAQ) and a Quick Reference Guide, are available on the PennERA web site. To access the documents, go to the PennERA Reference Materials page at https://rosetta.upenn.edu/cgi-bin/websec/websec_authform?app=RMDocs, authenticate with your PennKey and PennKey password, and see the "Human Subjects Electronic Research Application (HS-ERA)" section.

Questions
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If you have any questions, comments, or suggestions, please send an e-mail to hsera_help@lists.upenn.edu. For more information on HS-ERA, go to http://project.pennera.upenn.edu/project/current_phase/. For information on PennERA, please visit the PennERA web site at https://www.pennera.upenn.edu/.

--Marion Campbell, Todd Swavely, and Yvonne Higgins