All NEW STUDY applications must be submitted electronically using OSIRIS.

PAPER RENEWAL REQUIREMENTS - NEW INFORMATION

At this time all existing paper protocols that do not meet one of the exceptions noted below must be submitted electronically in OSIRIS at least 5 weeks prior to the expiration date. NOTE: Please read the exclusions carefully as they have changed.

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 OR submit the modification in paper prior to submission of the OSIRIS renewal.

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

• Study will be completed in 2009
• 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)
• Study is a research registry which is approved for the sole purpose of collecting information from participations for future contact. If you have questions about this exclusion, please contact the IRB Office
• Study is a coordinating center or data coordinating center
• Study was approved prior to 2005 - For this option, you must contact the IRB for permission to retain the submission in paper. Contact Jean Barone via e-mail (baronej2@upmc.edu) or by telephone (412-383-1480)