Department of Veterans Affairs
VA Long Beach Healthcare System
APPLICATION FOR CONTINUING REVIEW
AND MODIFICATION FORM
BASIC SCIENCE & IRB EXEMPT STUDIES
Instructions: Complete all sections of this form.
If there are any missing or handwritten sections the form will be returned.
Principal Investigator: (Last, First, MI, Degree)
Project Number (MIRB):
Date:
Project Title:
.
1. PROJECT STATUS
Original Approval Date:
a. Status of project:
Continuing
Completed (Closure)
Terminated
Modification
b. Based on study results, has the risk/benefit ratio changed for this study?
Yes
No
If yes, explain.
c. Has there been a change in the PI, or the PI’s role in the study?
Yes
No
If yes, explain:
d. Has there been a change in the PI’s duties at the VA?
Yes
No
If yes, explain:
e. Have the physical or financial resources that are available to the study decreased
since the last review?
Yes
No
If yes, explain:
VALBHS Version Date: Nov. 2012
2. STUDY PROGRESS
a. Provide a brief description of original protocol:
b. Provide a summary of study progress, research results obtained thus far and any new scientific
findings.
c. Since last report has there been any change in the financial interests of the Principal Investigator,
any co-investigator or their spouse or dependent child(ren), with respect to the sponsor or other
entity external to the VA whose business interests are related to the data or results of this study?
Yes
No
N/A (unfunded)
If “yes”, describe in detail the change in
financial interest. Use the space here or attach a separate sheet.
d. Has the Principal Investigator been an author or co-author on any published or submitted articles
since the last continuing review of this project?
Yes
No
review packet.
If “yes”, include copies of all submitted/published work with this continuing
3. PERSONNEL
a. List all personnel associated with this project.
b. Has there been any change in staff since the last review?
Yes
No
If yes, list name (s) and reason(s):
VALBHS Version Date: Nov. 2012
4. PROJECT MODIFICATION
a. Describe the modification(s) requested including the reasons:
b. Describe the additional staff and their qualifications:
c. Describe deleted staff and reason why:
5. CERTIFICATION:
By signing this document, I attest that all the information I have provided is accurate to the best of
my knowledge. I certify that the benefits to be gained from this study are commensurate with the
risks involved. I will immediately report any complications arising from this study to the Research
and Development Committee. I certify that all investigators and research staff have completed an
approved educational program. I certify that none of the modification changes have been made
and that no changes will be implemented prior to R&D Committee review and approval.
Principal Investigator
(signature)
Date
REQUEST FOR MODIFICATION PORTION
_____ The modification required additional changes to secure approval.
_____ The modification has been reviewed and approved by the R&D Committee.
Comments:
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________
Christopher Reist, MD
ACOS/Research & Development
VALBHS Version Date: Nov. 2012
________________________
Date