NeuroNEXT ADMINISTRATIVE PRE-REVIEW CHECKLIST
PI Name:_
____________________
Training Current?
Funded by Grant?
Yes
No
IRB-HSR #
No If no, who? _
Yes GIRB #
Is the PI an attending at UVa?
Yes
_____________
_________________________________________________________
List as Sponsor in database
No
Conflict of Interest Review
Are any IRB-HSR members/alternates listed on the protocol or 1572 form?
If yes, manually enter their names in IRB Online as having a conflict for this protocol.
Have you verified with School of Medicine (Wasserman) if there is a conflict?
This verification is required regardless of how PI answered the question below.
Yes
No
Yes
No
Has the PI stated on the NeuroNEXT Protocol Information Form that there is a Conflict of Interest?
Yes
No
Per the NeuroNEXT IRB AA (III.4.b) if a conflict exists, the SOM will provide the following information to the IRB-HSR.
The IRB-HSR will submit the information to NeuroNEXT CIRB:
i.
A copy of any report of investigator financial conflicts of interest (“FCOI Report”) made by UVa to NINDS
pursuant to the Public Health Service regulations on Promoting Objectivity in Research, 42CFR Part 50, Subpart
F ( the “Public Health Service Regulations”);
ii.
The specific information pertaining to the nature and management of reported FCOIs that is specified in 42CFR
part 50.605(b)(3) as will be in effect as of August 24, 2012, whether or not required under the current Public
Health Service Regulations or included in such FCOI Report; and
iii.
A description of any other steps (together with supporting information) that UVa has determined are necessary
to address financial interests of its investigators relating to the Clinical Study.
ADDITIONAL APPROVALS/REVIEWS
NONE
If any of the items below are applicable- they should be checked below and on regulatory page of IRB Online.
Forward approvals and any additional requirements from these groups to NeuroNEXT CIRB
Cancer Center Protocol Review Committee (PRC)
NA
Pending Approval
On file
Institutional Biosafety Committee (IBC)
NA
Pending Approval
On file
New Medical Device Form
NA
Pending Application
On File
Radiation Safety/ HIRE/ RDRC
NA
Pending Approval
On file
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Approval New Protocol Event Process:
1. Manually assign a IRB-HSR # and enter information from Protocol Information Form into IRB Online.
2. Designate IRB of Record as NeuroNEXT CIRB (Partners)
3. Enter Type as applicable per NeuroNEXT CIRB review type.
4. Change status to “Open to Enrollment”
5. Enter approval and expiration dates. These must be the same dates as the NeuroNEXT CIRB
approval/expiration date.
6. Remove Next 5 Year Review date.
7. Do not enter Last Meeting or Next Meeting Date.
8. Enter event “Approval New Protocol”, under Type "Expedited" into the IRB-HSR IRB Online.
9. Write in comment section “Receipt of Approval from NeuroNEXT CIRB.
10. No IRB-HSR Assurance is utilized as the IRB-HSR is NOT the IRB of record.
11. Verify all approvals from UVa applicable committees have been received and note them on the
regulatory page.
12. Confirm approval of HIPAA and Injury language in consent and sign the NeuroNEXT form approving
the language.
13. Verify current training completion and create the Training Certificate and email to study team.
14. Save all submitted documents and the forms noted below on the U drive under Current IRB Protocols &
Consents/ NeuroNEXT CIRB:
 Training certification form
 Admin Pre-Review Checklist
Administrative Staff Completing Form at Pre-review:
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Date