Review of Translated Consent Forms, PROs, and Other Patient-Facing Documents

This document outlines the different kinds of submissions for the review of translations and the submission requirements for each type of document.

Consent Forms

NCTN and NCORP study consent forms are translated by the CTSU into Spanish and submitted to the CIRB by the CTSU for the Study Team.  These submissions require a translated Spanish version of the CIRB-approved English consent form and a Certificate of Accuracy.  And a completed Translation Application.

Non-NCTN or non-NCORP translated consent forms are submitted via IRBManager to the CIRB directly by Study Teams. These submissions require a translated version of the CIRB-approved English consent form, a Certificate of Accuracy, and the CIRB approval letter for the English language consent form to verify prior approval. And a completed Translation Application.
 
The Certificate of Accuracy requires that the Translator/Vendor attests to the accuracy of the translation. Please ensure that the Certificate of Accuracy includes the Study number, reference to the name of the English consent form document(s), and its Protocol Version Date. The versioning on all three documents (the CIRB-approved English consent form(s), other language consent form(s), and the Certificate of Accuracy) must match. In the case of the Certificate of Accuracy for consent forms that version needs to be the Protocol Version Date. 

PROs and Other Patient-Facing Materials from an Outside Source

Outside sources are any entity that has created Patient Reported Outcome Questionnaires, Quality of Life Questionnaires, or other patient-facing materials that have been made available to the public and/or are commercially available in both English and other languages. A Study Team would not have created this in-house.  Outside sourced materials in both English and other languages may be submitted together and the translated other language versions do not require a Certificate of Accuracy because they have been made available in languages approved for use by the organization that created the material. Submissions will include completion of the Translation Application. 

Examples: FACIT, PROMIS, PRO-CTCAE, EORTC Patient Reported Outcomes Questionnaires. Also, NCCN Thermometer, Komen brochures, OMNIGene specimen collection instructions. 

These submissions should include the English version of the document and the translated versions of the documents for approval by the CIRB. At the discretion of the Study Team, the English and other language versions can be submitted separately. If outside-sourced translated materials are submitted separately after their equivalent English outside-source material has CIRB approval, provide the CIRB approval letter for the English outside-source material. 

PROs and Other Patient-Facing Documents created by the Study Team

This category is for PROs, recruitment materials, or other study documents (e.g., pill diary or drug handout) that are created by the Study Team and translated by the Study Team for use by all sites enrolling participants onto the study.

This category may also include documents created by an outside source (not created by the Study Team) that have been revised/modified and then translated by the Study Team.    

The submission of these documents includes the approval letter for the English language document(s), the translated version of the documents for approval by the CIRB, and a Certificate of Accuracy.  The CIRB’s request for the approval letter for the English language document verifies prior CIRB approval and confirms there are no changes to the English version of the document(s) prior to translation. Submissions will include completion of the Translation Application. 

The translated other language document/materials must have the same versioning as the CIRB Approved English document/material. The versioning may be indicated by a Protocol Version Date, version date, version number, or any combination of these. 

The Certificate of Accuracy requires that the Translator/Vendor attests to the accuracy of the translation and identifies the Study number, references the name(s) of the English document/study material and the version of the English material. The versioning on all three documents (the CIRB-approved English document/material, other language document/material, and the Certificate of Accuracy) must match. 

Combined Documents

Combination Documents are translated materials composed of at least two or more sub-sections. For example, there may be multiple different PROs included in one document. A combination document could consist of any of the following:

• PROs created and translated by the Study Team
• PROs created and translated by an outside source 
• PROs created and translated by the Study Team and documents created and translated by an outside source

Combination Documents composed solely of outside source instruments/materials would follow the same requirements for outside source translations outlined above. No Certificate of Accuracy is required. 

Combination Documents composed of outside source instrument/materials and either materials created by the Study Team or outside source instrument/materials modified by the Study Team must include Certificates of Accuracy for these latter types of sub-sections.  These types of Combination Documents cannot be submitted at Initial Review or Amendment Review. 

In the Translation Application, Study Teams will need to list the components of their combination document and any versioning unique per component.  Submissions of these types of combination documents would follow the same requirements as “PROs and Other Patient-Facing Documents created by the Study Team.”