Form 50 Reviewer Worksheet Translated Docs

REVIEWER WORKSHEET/CIRB OUTCOME LETTER
FOR TRANSLATED DOCUMENTS

Attachment_B34_Rev_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 15 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.

STUDY ID:
STUDY TITLE:
PROTOCOL VERSION DATE:
STUDY CHAIR:
CIRB Operations Office Verification of Complete Submission
Staff Member completing verification:
(Note: upon posting remove member name and add the word “Verified”.
Check off below to indicate required documents are attached:
A completed Request to Review Translated Documents (specific to this request)
The CIRB-approved English language document corresponding to the translated document
A translated copy of the CIRB-approved English language document
Translator’s Certificate(s) of Accuracy or equivalent document(s)
A copy of the CIRB approval letter for the English language document and protocol with corresponding
Protocol Version Date (from CIRB Operations Office files)

Review
Reviewer:
(Note: upon posting remove reviewer line)
The reviewer must confirm the following by checking off each of the boxes below:
The submitted English language document is CIRB-approved
The Protocol Version Date, if applicable, corresponds with the CIRB-approved protocol

July
2018
Version
dated 07/12/11 Updated 7/6/17

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A Translator’s Certificate of Accuracy or equivalent document is provided

If all of the above are confirmed, then the translated document may be approved.
Determination
Check one:
Approve
Date of Approval:
Forward for review by the convened CIRB
Additional Comments:

Reviewer Name

July
2018
Version
dated 07/12/11 Updated 7/6/17

Role

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