Form 49 CIRB App for Translated Docs

CIRB APPLICATION FOR TRANSLATED DOCUMENTS

Attachment_B33_App_Translated_Docs

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

The purpose of the information collection is to conduct reviews of clinical trial studies. NCI guidelines mandate the participation of institutions
in the CIRB for Network group studies. You are being requested to complete this instrument so that we can conduct activities involved with
the operations of the NCI CIRB Initiative. Although your participation in Network group research and completion of the forms is voluntary, if
you wish to participate in the CIRB, you must complete all questions on the form. The information you provide will be combined for all
participants and reported as summaries. It will be kept private to the extent provided by law.

NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 30 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. Send 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 (0925-0753). Do not return the completed form to this address.

Complete and submit this form to request CIRB review of translated documents. If you
have any questions regarding the completion of this request, please contact the CIRB
Helpdesk at 888-657-3711 or ncicirbcontact@emmes.com.
In order for the CIRB to review and approve translated documents, the English language
version of the document must already have CIRB approval.
STUDY NUMBER:
STUDY TITLE:
PROTOCOL VERSION DATE:
This request should be based on the current CIRB-approved Protocol Version Date.
STUDY CHAIR:
The Study Chair requests CIRB review and approval of the following translated documents.
Please check all that apply:
Informed Consent Document (ICD). If submitting multiple ICDs, please list titles
below:
1.
2.
Other documents (please list below):
Application
July
2018 version dated 07/12/11_update date 07/6/14

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1.
2.

Additional Required Documents. Check off below when document is attached:
CIRB-approved English language document(s) corresponding to the translated
document
Translated version(s) of the CIRB-approved English language document
Translator’s Certificate(s) of Accuracy or equivalent document(s)

July 2018

Application version dated 07/12/11_update date 07/6/14

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