Form 2 IRB Certification

Attachment_A02_IRB Certification

OMB# 0925-0753
Expiration Date 07/31/2021

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comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705
Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (OMB#0925-0753). Do not
return the completed form to this address.

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Attachment_A02_IRB Certification

Cancer Trials Support Unit
INSTITUTIONAL REVIEW BOARD
CERTIFICATION
1) Protocol #: (Lead Group #)

OMB# 0925-0753
Expiration Date 07/31/2021

Submit to the CTSU Regulatory Office via the
Regulatory Submission Portal: www.ctsu.org.
2) Protocol Version Date:

3) Protocol Title:
4) Institution Name (List all institutions covered by IRB approval that will conduct this study.
Attach supplemental list if necessary.)
Indicate # sites on supplemental sheet if applicable:

6) Principal Investigator:

5) NCI Institution Code

7) NCI Investigator #:

This activity has been reviewed and approved by the IRB in accordance with the Common Rule and any other governing regulations or
subparts:
8) Approval Type:
9) Review Type:
Original ☐

Amendment ☐

Renewal ☐

Full Board ☐
Expedited* ☐
*Provide OHRP Expedited Review Category in Box 10

10) Expedited Review Categories (Pick only one for Box #9):
(45CFR46.110.8a-c: Continuing review of research previously approved by a convened IRB)
8.a Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all researchrelated
interventions; and (iii) the research remains active only for long-term follow-up of subjects
8.b Where no subjects have been enrolled and no additional risks have been identified
8.c Where the remaining research activities are limited to data analysis
10a) Other Expedited Review Categories outlined on OHRP's website:
11) Date of IRB or Designee Review from box 9:

12) Approval Period: Effective Date must be on or after Box 13
date.
Effective:
Expiration:
15) Comments:

13) Was the protocol approved with contingencies? ☐ YES ☐ NO
Provide date all contingencies were
approved by the IRB or Designee:
14) OHRP IRB Registration Number (8 digits long):
IRB
The official signing below certifies that the information provided above is correct and that, as required, future reviews will be
performed & certification will be provided. Questions #1 through #20 must be completed for this form to be accepted.
Check here if the person signing this form is an IRB signatory as documented on the institutional assurance with OHRP. ☐
16) Name of IRB Signatory:
17) Name of approving IRB:
18) Title of IRB Signatory:

19) Phone:

20) Signature:

21) Date:

In Reference to Protocol #:
Final_July_2018
Authorized by CTSU for local reproduction

Attachment_A02_IRB Certification

Cancer Trials Support Unit
INSTITUTIONAL REVIEW BOARD
CERTIFICATION
Additional Institution Names (List all additional institutions covered
by IRB approval that will conduct this study.)
Ex. University of Texas
1)
2)
3)
4)
5)
6)
7)
8)
9)
10)
11)
12)
13)
14)
15)
16)
17)
18)
19)

Final_July_2018
Authorized by CTSU for local reproduction

OMB# 0925-0753
Expiration Date 07/31/2021

Submit to the CTSU Regulatory Office via the
Regulatory Submission Portal: www.ctsu.org.
NCI Institution
Code
TX002