FULL BOARD SUBMISSION CHECKLIST
REQUIRED documentation for all New Full Board 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.
 One (1) original of the IRB-HSR consent(s) including IRB-HSR# in header
 One (1) original of the IRB-HSR Short forms (if applicable)
 One (1) copy of PRC approval notice and Response Letter from PRC (if applicable)
 One (1) copy of the School of Medicine (SOM) Clinical Trials Office Review (if required: need for IND/IDE)
 One (1) copy of the SOM Clinical Trials Office Approval (if required: PI of IND/IDE or PI of multisite trial)
 One (1) copy of Radiation Safety Committee (HIRE) Review (if required)
 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) copy of Data Security Plan
 One (1) 5 Year Update Summary Form (5 Year updates only)
 One (1) Request for Modification Form (5 Year updates only-if applicable)
 One (1) Document Submission Form (if applicable)
At the time of hard copy submission, ALL documents, as noted on the form, should be included on a CD
for submission. Detailed instructions may be found on the form.
Three additional PACKETS (all items stapled) that include ALL PROTOCOL BULDER GENERATED DOCUMENTS:
 IRB-HSR protocol cover sheet with questions
 IRB-HSR consent(s) , including Short forms (if applicable) with IRB-HSR # in header
 IRB-HSR protocol OR IRB-HSR application with IRB-HSR# in header
Website: http://www.virginia.edu/vpr/irb/hsr/index.html
Phone: 434-924-2620 Fax: 434-924-2932 Box 800483
Version date: 03-31-16
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