EXPEDITED SUBMISSION CHECKLIST
REQUIRED documentation for all New Expedited Protocols and Five Year Updates at the time of hard copy submission
Incomplete submissions will result in delay of IRB-HSR review. Some circumstances may require the submission of other material
in addition to the items listed below.
IRB-HSR Routing Form with Contact Information
One ORIGINAL packet that includes

One (1) original Protocol Cover sheet with questions

One (1) original IRB-HSR protocol or IRB-HSR application, signed and dated by the PI and Department Chair (DC) and includes
IRB-HSR # in header. Note: DC signature not required for Five Year Updates.

Two (2) original of the IRB-HSR consent including IRB# in header

One (1) copy of PRC approval notice and Response Letter from PRC (if applicable)

One (1) copy of the School of Medicine Clinical Trials Office Review (if required: need for IND/IDE)

One (1) copy of the School of Medicine Clinical Trials Office Approval (if required: PI of multisite trial)

One (1) Certificate of Confidentiality Application (if applicable)

One (1) Conflict Management Plan from Conflict of Interest Committee (if applicable)

One (1) New Medical Device Application (if applicable)

One (1) 5 year Update Summary Form (5 Year updates only)

One (1) Request for Modification Form (5 Year updates only)

One(1) Document Submission Form
You are required to complete and EMAIL the Document Submission Form to the IRB pre-reviewer. This form should include a log of
all additional documents including (but not limited to):
 Sponsor protocol,
 Surveys/questionnaires,
 FDA correspondence,
 Lab/study/Device manuals,
 Any additional item(s) that the sponsor or UVA study team wants the IRB to acknowledge
At the time of hard copy submission, ALL documents, as noted on the form, may be included on a CD for submission. Hard copies of
these documents are NO longer required. Detailed instructions may be found on the form.
Website: http://www.virginia.edu/vpr/irb/hsr/index.html
Phone: 434-924-2620 Fax: 434-924-2932 Box 800483
Version date: 04-23-14
Page 1 of 1