PennAEs: New Tracking/Reporting Function Now Available
The Penn Human Subjects Adverse Events Reporting System (PennAEs) was enhanced as of February 8, 2006 to enable tracking/reporting on unanticipated problems posing risk to subjects or others. PennAEs is a web-based application that has been used extensively by researchers at Penn to track and collect adverse events in clinical trials and report on serious adverse events involving human subjects to the Institutional Review Boards (IRB). The new functionality will allow Principal Investigators to electronically submit reports involving risks to participants or others to the IRB. Such unanticipated events, problems, or effects on human subjects that may change the weight or the interpretation of the risks of a research study must be reported to the IRB as soon as they are identified, and the newly enhanced PennAEs system will better allow users to meet this reporting requirement.
What are unanticipated problems?
Unanticipated problems involve risks to participants or others and
• Refer to untoward or unanticipated events or new findings involving any aspect of a research study
• Are events involving anyone, including participants, research staff, or others not directly involved in the research
• Are always unanticipated by definition and the risks not discussed in the research protocol
• Can occur in either clinical or social and behavioral research, whether exempt, expedited, or full board review
• Require prompt reporting to the IRB, appropriate institutional officials, and the Department or Agency head if funded.
The ability to electronically track and submit reports of unanticipated problems to the IRB will facilitate reporting, meet regulatory requirements, and replace the manual process that is currently in place. In addition, it will assist investigators in handling the outcome of such events.
Access to the unanticipated problems tracking/reporting function is via an additional button on the opening screen of the PennAEs application. Existing users will log on to PennAEs as usual, authenticating with their PennKey ID and password before accessing the system with a standard web browser. New users who are not Principal Investigators who require access to PennAEs (data coordinators for example) will need to complete and submit a PennAEs Access Request Form located on the web at www.finance.upenn.edu/ftd/weblearn/PennAEs/pdf/pennae_access1.pdf.
Online Reference Materials
Updated reference materials, including a user guide and a glossary of terms, are available from the PennAEs online help site at www.finance.upenn.edu/ftd/weblearn/PennAEs/.
For more information about PennAEs, contact firstname.lastname@example.org or visit the PennAEs online help site at www.finance.upenn.edu/ftd/weblearn/PennAEs/.
—Robin H. Beck,
Vice President of Information Systems and Computing
—Andrew B. Rudczynski, Executive Director of Research Services and
Associate Vice President of Finance
—Joseph R. Sherwin, Director of the Office of Regulatory Affairs
Almanac, Vol. 52, No. 22, February 14, 2006