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All NEW STUDY applications must be submitted electronically using OSIRIS.

NEW PAPER RENEWAL REQUIREMENTS

All existing paper protocols that are due to expire after September 1, 2008 must be submitted electronically in OSIRIS at least 5 weeks prior to the expiration date.

This process is to be used only for paper protocols that are due for Renewal. This process will bypass the need for another scientific review or ancillary review (except for the review fee if industry sponsored). No modifications to the paper studies in conversion will be permitted at this time. Because of the way that OSIRIS is structured, investigators may need to provide additional information in response to questions that were not addressed in the original paper submission. If you wish to submit a modification, you will need to wait until the OSIRIS paper conversion approval has been obtained.

Renewals may remain in the paper format if any of the following criteria are met:

• Study will be completed in 2008
• Study is in data analysis only
• Study is limited to long-term follow-up (the IRB considers long-term follow-up to be limited to the review of medical records [i.e., information collected for clinical purposes] and review of survival status either by contacting the subject or querying the National Death Index)

If you have any questions, please contact Jean Barone, Assistant IRB Director, at baronej2@upmc.edu.

For further information about the conversion process please click here