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Human Subjects Electronic Research Application (HS-ERA)

A secure, web-based protocol application for Human Subjects research has been developed for the research community at Penn. This application, called the Human Subjects Electronic Research Application (HS-ERA), is part of the PennERA (Electronic Research Administration) initiative to build an integrated and automated environment for pre- and post-award processes for enhanced administrative support of, and to meet regulatory requirements for, grants.

What is HS-ERA?

The Human Subjects Electronic Research Application (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. HS-ERA includes electronic notifications to internal review entities and the ability for the IRB member to review protocols.

Who should use HS-ERA?

HS-ERA can be used by members of the research community involved in Human Subjects Protocol creation, submission, routing, or approval, including members of the Institutional Review Boards (IRB), the Office of Human Research (OHR), and ITMAT's Clinical and Translational Research Center (CTRC). The following other internal review entities with appropriate access may also use this application to view a protocol:

  • OEHRS (all radiation exposure questions)
  • IDS (only when appropriate)
  • Gene Transfer
  • CACTIS (CT only)
  • CAMRIS (MRI only)
  • Investigational agent or device in the OR
  • CTSRMC (cancer patients)
  • COI (Conflict of Interest)
  • Specimen Processing by Pathology
  • Analysis of Biological Fluids
  • Research Involves Apheresis or Cell Collection
  • CTRC
  • ORS
Benefits of HS-ERA

Key benefits of HS-ERA include:

  • Streamlined submission process, eliminating the need for researchers to copy and deliver multiple copies of a protocol to other University review units, and eliminating duplicative data entry
  • Enhancing regulatory compliance through integration of organizations that support Human Subjects research, including CHOP, CTRC, OHR, and ORS
  • Ability for Investigators to reuse data and reduce manual efforts associated with the submission of protocols
  • Improved process efficiency and accuracy through electronic routing for approvals and review and automatic generation of alerts/notifications based on status changes
  • Easy access to review progress and status of the protocol review
  • Secure access to information, including historical data
  • Ability for IRB Board Members to electronically review Human Subject Protocols
Unanticipated Problems functionality

HS-ERA incorporates the capability to report unanticipated problems posing risk to human subjects including reportable adverse events. As such, the former system for reporting adverse events, PennAEs, has been retired. Users are able to report unanticipated problems both for protocols created in HS-ERA or for those currently existing in the PennERA system.

Access

HS-ERA is available to all researchers at Penn with a valid PennKey and Password. See the HS-ERA Access page at https://medley.isc-seo.upenn.edu/hsProtocol/jsp/fast.do

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Questions

Questions about HS-ERA can be addressed to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

 
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