Form 6U Reviewer Worksheet of Translated Documents REV

REVIEWER WORKSHEET/CIRB OUTCOME LETTER

FOR TRANSLATED DOCUMENTS

OMB#: 0925 – 0625

Expiry Date: 01/31/2014

Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of your participation in the National Cancer Institute (NCI) Central Institutional Review Board (CIRB) Initiative is protected by The Privacy Act of 1974, as amended. The purpose of the information collection is to conduct reviews of clinical trial studies. Although your participation in NCI-sponsored 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 (0925-0625). Do not return the completed form to this address.

 

STUDY NUMBER:      

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

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

Forward for review by the convened CIRB

Additional Comments:      

R eviewer Name Role

Version dated 07/12/11 Page 2 of 2