Western IRB Procedures and Forms
PROCEDURE:
New Approval ( If protocol does NOT fall under the
authority of the Cancer Center)
1. Researcher completes the WIRB Submission Form
2. Simultaneously, a protocol information form (Appendix B) is sent to the IRBHSR. The IRB-HSR office will confirm current training and send back a training
certificate.
3. All documents are reviewed by the PI.
4. Documents are submitted online to WIRB by the study team.
5. Once WIRB has approved the protocol, the following documents will be
submitted to the IRB-HSR within 5 working days:
 WIRB Submission Form
 Sponsor’s protocol
 Approved consent form
 UVA HIPAA Stand-alone Authorization
 IRB-HSR/WIRB Investigator Agreement (Appendix A)
 Documentation of any local committee approvals required (e.g. Radiation
Safety Committee, Institutional Biosafety Committee, GCRC)
 Documentation of WIRB approval
6. An administrative review by IRB-HSR staff is completed. IRB-HSR staff verify
all documents are in order and approvals from all other applicable committees
have been received. (Appendix B)
7. Documentation of all subsequent approvals from WIRB is to be submitted to IRBHSR within 5 working days of receipt.
New Approval ( If protocol falls under the authority of
the Cancer Center)
1. The Principal Investigator notifies the Cancer Center IRB Coordinator/Study
Coordinator of the name of the Cooperative Group Trial he/she wishes to open.
2. The Cancer Center IRB coordinator/study coordinator in conjunction with the PI
completes the WIRB Submission Form and the consent form using the NCI
template.
3. Simultaneously, a protocol information form (Appendix B) is sent to the IRBHSR. The IRB-HSR office will confirm current training and send back a training
certificate.
4. All documents are reviewed by the PI.
5. Documents are submitted online to WIRB by the study team
6. Once WIRB has approved the protocol, the following documents will be
submitted to the IRB-HSR within 5 working days:
7. WIRB Submission Form
8. Sponsor’s protocol
9. Approved consent form
10. UVA HIPAA Stand-alone Authorization
11. IRB-HSR/WIRB Investigator Agreement (Appendix A)
12. PRC application form (Appendix C)
13. Documentation of any local committee approvals required (e.g. Radiation Safety
Committee, Institutional Biosafety Committee, GCRC)
14. Documentation of WIRB approval
15. IRB-HSR staff add a IRB-HSR # to the PRC Application Form and forward it to
the PRC office.
16. An administrative review by IRB-HSR staff is completed. IRB-HSR staff verify
all documents are in order and approvals from all other applicable committees
have been received. (Appendix B)
17. Documentation of all subsequent approvals from WIRB is to be submitted to IRBHSR within 5 working days of receipt.
Continuations

Upon receipt of a continuation approval from PI/WIRB, IRB-HSR staff
will:
i. Verify training completion
ii. Provide PI with Training Certification
Modifications

Upon receipt of a modification approval from PI/WIRB, IRB-HSR staff will
enter information into IRB Online and file documents.
Advertisements
All advertisements will be submitted to WIRB and approved prior to use.
 Upon receipt of an advertisement approval from PI/WIRB, IRB-HSR staff
will:
 Enter “Receipt” event in IRB-HSR IRB Online. Write in comment section
“WIRB Advertisement Approval”.
 File documents in IRB-HSR file.
Protocol Violations and Deviations
The PI is responsible for submitting protocol violations and deviations to the WIRB.
Adverse Events
Adverse events are to be submitted to WIRB by the PI according to WIRB policies.
Appendix A: Investigator Agreement for WIRB Protocols
UNIVERSITY OF VIRGINIA
IRB FOR HEALTH SCIENCES RESEARCH
INVESTIGATOR AGREEMENT FOR PROTOCOLS APPROVED BY
THE WESTERN IRB
Title of Study:
_____________________________________________________________________________________
BY SIGNING THIS DOCUMENT, THE INVESTIGATOR AGREES:
1. That no subjects will be recruited or entered under the protocol until the Investigator has received
approval from WIRB.
2. That any materials used to recruit subjects will be approved by the WIRB prior to use.
3. That any modifications of the protocol or consent form will not be initiated without prior written approval
from the WIRB, except when necessary to eliminate immediate hazards to the subjects.
4. That any serious deviation from the protocol will be reported promptly to the WIRB in writing.
5. That adverse events will be reported to WIRB according to their policies.
6. That the continuation status report for this protocol will be completed and returned to WIRB within the
time limit required.
7. That all subjects will sign a copy of the most current non- expired consent form.
8. That the IRB-HSR office will be notified within 30 days of a change in the Principal Investigator or of the
closure of this study.
9. That no personnel will be allowed to work on this protocol until they have completed the IRB-HSR
Online training and the IRB-HSR has been notified.
________________________
Principal Investigator
(Name Printed)
__________________________
Principal Investigator
(Signature)
___________
Date
BY SIGNING THIS DOCUMENT, THE CHAIR AGREES:
1.
2.
3.
To assume overall responsibility for the conduct of this investigator.
To work with the investigator, and with WIRB and the IRB-HSR as needed, to maintain compliance
with this agreement.
That the Principal Investigator is qualified to perform this study.
_____________________________
_____________________________
Department Chair/Division Head*
Department Chair/Division Head
(Name Printed)
(Signature)
*(Cannot be Principal Investigator or Sub-investigator)
__________
Date
The Committee reserves the right to terminate this study at any time if, in its opinion, (1) the risks of further
experimentation are prohibitive, or (2) the above agreement is breached.
For Use by IRB-HSR Office
IRB-HSR # __________
Revised 09-28-09
Page 1 of 1
Appendix B: WIRB/IRB-HSR Protocol Information Form
IRB-HSR/WIRB
Protocol Information Form
Sponsor Protocol #______________(If Applicable)
Title:__________________________________________________________________________
______
Do you/will you have a contract with an outside sponsor for this protocol?
Yes
No
If yes- name of group you will have contract
with:___________________________________________________________________
Is this protocol funded by a Grant?
Yes
No
If Yes- GHIC# for Approved Grant ______________
Does this study involve an investigational drug or use of a drug for an unapproved
indication/dose/route of administration?
Yes
No
Is this protocol part of an outside sponsored IND?
Yes
No
If Yes- IND#_____________________
Does this study involve an investigational device or use of an approved device for an
unapproved indication?
Yes
No
If Yes, Investigational Device Exemption
IDE#____________________________
Yes
No
If Yes, is this protocol part of a UVA Physician sponsored IDE?
If Yes,
School of Medicine Clinical Trials Office/DSMB approval required.
Does this study involve the use of radiation for research purposes?
Yes
No
If Yes, Radiation Safety Committee approval is required unless standard
wording from the IRB-HSR Website is used.
Will any part of this study be done in the GCRC?
Yes
No
If Yes, GCRC approval required. Attach one copy of GCRC submission.
GCRC#___________
Does this study involve the use of recombinant DNA, biological vectors or infectious agents?
Yes
No
If Yes, IBC approval required. IBC#____________
To avoid any conflict of interest are any IRB-HSR members/alternates listed on the protocol
or 1572 form?
Yes
No
If Yes, please list names below.
______________________________________
______________________________________
Will you be using any specimens from a human? Yes No
Will all collection (i.e. blood drawing) and processing (i.e. anything
that involves the specimen container to be opened) occur in a UVA
clinic/hospital or clinical lab?
Yes No
If No- attach approval from the Institutional Biosafety Committee
IBC#__________
If you need to register with the IBC go to
http://keats.admin.virginia.edu/bio/home.html
Revised 2-22-06
INVESTIGATORS
PLEASE NOTE:



If an individual is a UVA employee, please list his/her official UVA registered e-mail address. Do not list an alias e-mail
address on IRB-HSR forms. Ex: use srh@virginia.edu, not SRHoffman@virginia.edu.
ALL individuals having contact with subjects or their identifiable information for this protocol must be listed below.
All e-mails from the IRB-HSR regarding a protocol will be sent to the PI, Study Coordinator(s) , Department Contact and IRB
Departmental Coordinator (if applicable)
Principal Investigator: (First) _________________
(Last)____________________________________(Degree)____________
Phone ____________________ E-mail___________________________ Messenger Mail Address
_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Note: only 1 person may be listed as the PI by the IRB-HSR- please list others as sub-investigators. If the PI is NOT a faculty
member a faculty member must be listed as a sub-investigator. Students are not allowed to be the Principal Investigator.
Study Coordinator I: (First) ____________________
(Last)____________________________________(Degree)____________
Phone____________________ E-mail___________________________ Messenger Mail
Address__________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Study Coordinator II: (First) ____________________
(Last)____________________________________(Degree)____________
Phone____________________ E-mail___________________________ Messenger Mail
Address__________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Department Contact: (First) ___________________
(Last)___________________________________(Degree)____________
Phone___________________ E-mail_____________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Note: Usually a person who knows how to get in touch with the PI or Study Coordinator if they’re unavailable (i.e. PI secretary/department manager). The Department Chair
should not be listed as the Department Contact.
Departmental IRB Coordinator: (First) ___________________
(Last)___________________________________(Degree)____________
Phone___________________ E-mail_____________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sponsor/Granting Agency Name:
______________________________________________________________________
Address: ________________________________________ Phone: _______________________ Fax:
_________________
City, State, Zip:
______________________________________________________________________________________
Revised 12-18-06
Page 1 of 2
Sub-investigators
List ALL individuals who will have contact with subjects or will have access to research data that has identifying information
(e.g.-subject name or medical record number)
Sub-investigator: (First)
______________________(Last)__________________________________(Degree)_______
_
Phone_______________ E-mail___________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First)
______________________(Last)__________________________________(Degree)_______
_
Phone_______________ E-mail___________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First)
______________________(Last)__________________________________(Degree)_______
_
Phone_______________ E-mail___________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First)
______________________(Last)__________________________________(Degree)_______
_
Phone_______________ E-mail___________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First)
______________________(Last)__________________________________(Degree)_______
_
Phone_______________ E-mail___________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First)
______________________(Last)__________________________________(Degree)_______
_
Phone_______________ E-mail___________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Are there additional sub-investigators?
Revised 12-18-06
Yes
No
If Yes, attach additional pages.
Page 2 of 2
Appendix C: PRC Submission Form
UVA Cancer Center Protocol Review Committee/ Clinical Trials
Office
Protocol Submission Form
A.
General Information
IRB-HSR # _______
PI:
Date Submitted :
Protocol
Title:__________________________________________________________________
________________________________________________________________________
______
Sub-investigators on Study:
________________________________________________________
________________________________________________________________________
_______
Phase : Circle all that Intent-Check one
Type- Check one
apply
Pilot
Therapeutic
Pharmaceutical-other than NCI
sponsored
I-Non-Therapeutic
National Cooperative
Investigator Initiated (CRFs and AE
Group
forms must be submitted for
review)
II
Chemoprevention
III
Supportive Care
Does PI hold IND for study? ___ Yes ____No
Does this study involve only non-UVa patients? ____Yes ____ No
Is this a multi-center study? ___ Yes (if yes, what is the parent
institution:______________) ___ No
PRC Contact Information: (will be contacted regarding protocol review process and for
yearly reports)
Name_____________________________________ Phone Number: ___________________
E-mail Address_________________________________
What stage patient will be eligible for this study? Check all that apply: __1 __2 __3 __4
__All
What line of therapy is this? __First line __Second Line Plus (advanced, recurrent,
refractory pts.) __All
Will this study be conducted in the GCRC? Y N
If so, may we share PRC reviews with GCRC to expedite the GCRC review? Y
B.
N
Accrual Information
Is this study currently accruing at other institutions?
Yes
No
Date Opened
What is the expected study accrual period?
(Months)
What is the expected study duration (including the accrual period?)
(Months)
UVA Accrual Goal
Revised 3-16-04
Page 1 of 3
Objective Evidence supporting your ability to accrue to this study comes from:
Prior experience with similar patient population (specify previous study(s) and
accrual – be very specific!)
Tumor Registry data (specify)
Estimate of clinical population
Other
Are there overlapping eligibility criteria with another study?
There is no conflict
There is conflict which will be resolved by the following:
C.
Requested CTO Services
*If CTO resources are not requested, please skip this
section.
Please choose one of the following:
______ Study to be opened in CTO: CTO submits protocol to IRB, maintains and
updates IRB records, assists with protocol preparation (abbreviated protocol and
consent form), develops and processes study agreement, provides data
management/research nursing, coordinates site initiation visit and all
monitor/audit visits for life of study. Please attach data forms if available.
______ Study to be opened by PI: CTO submits protocol to IRB following PRC
approval, assists with protocol preparation (abbreviated protocol and consent
form).
______ Study to be opened by PI: CTO submits protocol to IRB following PRC
approval.
Please provide a description in the space below of the purpose and process of the trial in
layman’s terms to be posted on the website for patients. This should be no more than a
paragraph in length.
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
_______________________________________________________
*Please contact Beth Paris, CTO Manager, with any questions regarding CTO
procedures.
D. Agreement and Budget (Not required for
cooperative group trials)
The sponsor is
Have there been preliminary discussions/agreements?
Yes No
Who is the company contact for this study? (Please include name, telephone, fax and email if available)
What is the average number of cycles these patients will be on study?
What is the average survival time once placed on study?
Identify unusual tests or procedures to be covered by the study
Revised 3-16-04
E.
Page 2 of 3
Procedure for Protocol Submission
Protocols may be submitted to Catherine Reniere, Protocol Review Committee, in
the Health Evaluation Sciences Department, Rm. 3234, 3rd floor Multistory Building,
Box 800717. She may be contacted at ext. 3-6438 or by FAX at 924-8437 or by e-mail at
cr9b@virginia.edu. To expedite the review process, please submit your protocol in
electronic form if possible.
Deadlines for the monthly meetings are the first Monday of each month. The
Protocol Review Committee meetings usually occur on the third Monday of each month.
Protocols may be submitted at any time. Protocols submitted after the deadline will be
held for the following meeting.
The Principal Investigator should provide a brief cover letter outlining any unique
aspects of the study, in case other pertinent information concerning the protocol is not
covered by the PRC submission form. Abbreviated protocols are not acceptable for
treatment studies. It is not necessary to copy the Common Toxicity Criteria. Please
submit your protocol in electronic form if possible. If only a paper copy is available,
please provide 17 copies for the Committee.
If you need help or have further questions, please contact Catherine Reniere.
Revised 3-16-04
Page 3 of 3