Principal Investigator:
Study Title:


1.  Will any information from this project be submitted to the FDA or held for inspection by the FDA? No Yes If Yes, STOP and contact

2.  Will any member of this research team record patient names, ID numbers, or other linkage codes with the data abstracted from the medical records (even temporarily)? No Yes
If Yes, STOP – This project does not meet criteria for an exemption. A new application must be created and submitted for Expedited review with formal requests for waiver of consent and HIPAA Authorization

3.  Are all data currently in existence as of the date the application is submitted for IRB review?

No, STOP – This project does not meet criteria for an exemption. A new application must be created and submitted for Expedited review with formal requests for waiver of consent and HIPAA Authorization
Yes, List the specific date range of records to be studied: Click here to enter start of date range to Click here to enter end of date range

4.  Describe the extent to which this medical record review is consistent with the PI’s UPMC/UPP patient care responsibilities:

a.  Name the individual(s) who will conduct the medical record review (as PI or under the supervision of the PI):

5.  Specify the inclusion/exclusion criteria for the selection of medical records:

6.  Specify the approximate number of individual patient medical records that will be requested:

7.  Describe the location/source of the medical records to be accessed:

8.  If data will come from, or will be sent to, another institution, you must consult with the University of Pittsburgh Office of Research regarding any necessary transfer agreements (www.research.pitt.edu). If you intend to share data, this must be addressed in OSIRIS item 5.8.

9.  Additional information, clarification, or comments for IRB review:


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Final Process

·  Save this document to your computer and upload into OSIRIS item E2.0

·  You must answer Yes to OSIRIS item 2.14 to describe variables and 2.14.2 to justify the request for a waiver of HIPAA Authorization

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University of Pittsburgh §Human Research Protection Office § 3500 Fifth Avenue § Phone 412-383-1480 § www.hrpo.pitt.edu
v. 1.30.2016 2of 2