UCLA CTSI PROTOCOL REGISTRATION (CPR) NOTICE
Reviewing IRB Protocol #
Version 3/19/2012
Instructions to the Lead Principal Investigator at the
Reviewing IRB
Instructions to the Principal Investigator at the Relying
IRB
1. Review UCLA CTSI IRB Decision Tree for an overview of the
process and points to consider when determining which IRB
should provide review. Consult with the appropriate IRB
Administrator at your institution to confirm which IRB would be
better suited to review the project and to answer any questions.
2. Complete this Notice and ensure that information about the
research at the other CTSI Unit is included.
3. Obtain signature of the Relying PI on the Notice.
4. Submit completed Notice as part of your regular submission
to your Reviewing IRB.
5. Once approved by IRB, you can begin the study at your site
only.
1. Review UCLA CTSI IRB Decision Tree for an overview of the
process and points to consider when determining which IRB
should provide review. Consult with the appropriate IRB
Administrator at your institution to confirm which IRB would be
better suited to review the project and to answer any questions.
2. Complete appropriate sections Notice. See additional
submission requirements at your site.
3. Forward signed copy of the Notice to the PI at Reviewing IRB.
4. Wait for Acknowledgment Letter from your institution’s IRB.
5. Once you have received an Acknowledgment Letter, you can
begin the study at your site.
A. Reviewing CTSI Unit Lead Principal Investigator:
1. Reviewing Unit Study Title:
2. Application Type
[ ] New
[ ] Modification
[ ] Renewal (Continuing Review)
3. CTSI Unit Location Which Will Provide IRB Review:
[ ] Cedars-Sinai Medical Center
[ ] LA BioMed at Harbor-UCLA Medical Center
[ ] Charles Drew University
[ ] UC Los Angeles
4. Funding Information
Specify name of sponsor (s):
Have funds been awarded?
[ ] Yes [ ] Pending [ ] No
5. Who is the Primary Awardee Institution?
6. Who is the PI on this award?
7. Lead PI on the IRB Application:
Name and degree
Title
Department
Mailing Address
Phone Number
E-mail Address
Contact Person:
Name and degree
Title
Department
Mailing Address
Phone Number
E-mail Address
Additional Contact Person (if any):
Name
Title
Department
Mailing Address (Box No.)
Phone Number
E-mail Address
8. Provide a general description of the entire study. The description should be no more than half a page.
B. Relying Unit Principal Investigator [Provide a separate form for each site]
1. CTSI Unit Location Which Will Rely on the Reviewing IRB Review:
[ ] Cedars Sinai Medical Center
[ ] LA BioMed at Harbor-UCLA Medical Center
2. Funding Information For Relying PI
[ ] Charles Drew University
[ ] UC Los Angeles (Westwood)
a. Type of Funding
[ ]Contract/Grant
[ ]Subcontract
[ ]Drug/device donation
[ ]Departmental
[ ]Gift
[ ]Student project
[ ]Other:
b. Award Information:
[ ]Federal Government
[ ]Other Gov. (e.g., State, local)
[ ]Industry
[ ]Other Private
[ ]CTSI Unit/UC-Wide program
[ ]Departmental Funds
[ ]Other:
Have funds been awarded?
[ ] Yes [ ] Pending [ ] No
Specify name of sponsor:
3. PI at the Relying CTSI Unit:
Name and degree
Title
Department
Mailing Address
Phone Number
E-mail Address
Name and degree
Title
Department
Mailing Address
Phone Number
E-mail Address
Name
Title
Department
Mailing Address (Box No.)
Phone Number
E-mail Address
Contact Person:
Additional Contact Person (if any):
4. Provide summary of the Relying PIs human subject research activities. Include any of the study
procedures, interventions, diagnostics, or analysis that the relying PI will perform at the relying site.
5. Will the Relying PI recruit and consent subjects?
[ ] Yes [ ] No
If yes, please provide below a brief discussion of the following:
a. Types and numbers of subjects, and
b. How, when, where, and by whom are potential subjects approached?
c. Provide a brief description of how informed consent is obtained.
C. Other Approvals/Regulated Materials:
[ ] Yes
Does this study require approval or authorization at the Relying CTSI Unit from any of the following
[ ] No
oversight or regulatory committees, or involve the use of regulated materials listed below?
If “Yes”, complete the applicable section(s) below and identify which CTSI Unit will or has provided the review.
Acknowledgment Letters will not be provided from the Relying IRB if the below approvals are not in place.
Cancer Center Protocol Review Committee
Approval date:
CTSI Unit:
Institutional Biosafety Committee (IBC)
IBC#:
Approval date:
Approval date:
RSC#:
Approval date:
Approval date:
CTSI Unit:
Name and IND#:
CTSI Unit:
Name and IDE# or NSR Determination:
CTSI Unit:
Human Stem Cells Oversight Committee
Radiation Safety Committee (RSC)
Radioactive Drug Research Committee
(RDRC)
List any Investigational Drugs and Biologics
List any Investigational Devices and NonSignificant Risk Devices
CTSI Unit:
CTSI Unit:
CTSI Unit:
D. Statement of Financial Interest: Does the Relying PI or any of the relying
investigators have any financial interests according to your unit’s policies related to this
study? Important Note: The Relying PI will follow his/her institution’s requirements.
[ ] Yes [ ] No
E. Relying Principal Investigator and Lead Principal Investigator Assurances to the Reviewing
IRB:
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We certify that the information provided in this application is complete and correct.
We have assessed the resources required for participation at each participating site and have confirmed that proposed
research activities can be completed.
We certify that we will follow the IRB-approved Protocol.
We will comply with all applicable federal and state laws regarding the protection of human subjects in research.
We will make sure that the personnel performing this study are sufficiently qualified by training and experience and adhere
to the provisions of this IRB-approved protocol.
We will not modify this protocol or any attached materials without first submitting an amendment to the previously approved
protocol and receiving subsequent IRB approval from the Reviewing IRB.
We accept responsibility for the conduct of this study at this site, the ethical performance of the project, and the protection of
the rights and welfare of the human subjects who are directly involved at this site.
We certify that each participating investigator has completed the human subjects training as required by his/her home
institution.
________________________________________________________________________________________
Lead Principal Investigator’s Signature
Date
________________________________________________________________________________________
Relying Principal Investigator’s Signature
Date