2 IRB Certification

Attachment_A02_IRB Certification

OMB# 0925-0753

Expiration Date 05/31/2024

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Cancer Trials Support Unit INSTITUTIONAL REVIEW BOARD CERTIFICATION	Submit to the CTSU Regulatory Office via the Regulatory Submission Portal: www.ctsu.org.
1) Protocol #: (Lead Group #)	2) Protocol Version:
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:		5) NCI Institution Code
6) Principal Investigator:	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: Original ☐ Amendment ☐ Renewal ☐	9) Review Type: 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 research- related 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 11 date and on or after box 13 date, if applicable. Effective: Expiration:
13) Was the protocol approved with contingencies? ☐ YES ☐ NO Provide date all contingencies were approved by the IRB or Designee:	15) Comments:
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.
16) Name of IRB Signatory:	17) Name of approving IRB:
18) Title of IRB Signatory:	19) Phone:
20) Signature:	21) Date:

Cancer Trials Support Unit INSTITUTIONAL REVIEW BOARD CERTIFICATION	Submit to the CTSU Regulatory Office via the Regulatory Submission Portal: www.ctsu.org.
In Reference to Protocol #:
Additional Institution Names (List all additional institutions covered by IRB approval that will conduct this study.)	NCI Institution Code
Ex. University of Texas	TX002
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