COMPLETING THE TRANSLATION APPLICATION

Instructions, Study ID, Study Title, Event, and Study Chair

• The first three questions (Study ID, Study Title, and Study Chair) are prepopulated.
• The current Protocol Version Date is entered by the CIRB Operation Office when starting the application.  
   

Application

• Indicate the type of submission. Once the selection is made, additional questions related to that type of submission will appear. Study Teams may have more than one type of submission.  
• The first selection “Spanish Consent Form Translation form CTSU” is only for the translation submission of NCTN/NCORP consent forms by CTSU. 
• The second selection “Spanish or Other Language Consent Form from Study Team” is only to be used for consent forms translated by the Study Teams.
• The third selection “Translation of CIRB-approved materials by the Study Team (includes documents created by the Study Team OR obtained from an Outside Source and then translated (or modified) by the Study Team)” is for the following:
  1. Translations of documents created or modified by the Study Team, or
  2. Combination documents of two or more Patient Reported Outcome (PRO) / Quality of Life (QOL) sections that may include any of these three types:
     1. Outside Source PRO/QOLs,
     2. Study Team created PRO/QOLs, and/or
     3. Study Team modified outside source PRO/QOLs. 
• The fourth selection “Translation by an Outside Source created by an Outside Source being used as provided by the Study Team” is for documents obtained for use without modification or translation by the Study Team OR combination documents of at least two outside source PRO/QOLs. 
   

Spanish Consent Form Translation from CTSU Submission

1. Enter the Protocol Version Date (PVD) for the consent form(s) being submitted.  
2. Enter the number of consent form(s) being submitted.  If more than one, provide the identifier for each consent form being submitted (e.g., Phase I and Phase II).
3. Indicate if the PVD was the only change made to the consent form(s).  If there are multiple consent forms for the given study and some changed and some had only the PVD change, indicate the consent forms where only the PVD changed.
4. The Spanish consent form(s) should be attached.
5. The certificate(s) of accuracy should be attached as applicable for any consent forms with revised translated sections.  Ensure that the study number, consent forms translated, and the PVD are accurately captured on the certificate(s) of accuracy and are consistent with the consent form(s) being submitted.
6. Provide any other information regarding the submission, if applicable.

Spanish or Other Language Consent Form Translation from the Study Team

1. Enter the number of consent form(s) being submitted.  If more than one, provide the identifier for each consent form being submitted (e.g., Phase I and Phase II).
2. Indicate if the PVD was the only change made to the consent form(s). If there are multiple consent forms for the given study and some changed and some had only the PVD change, indicate the consent form(s) where only the PVD changed. Attach the consent form(s) and indicate the language(s) being provided for approval.
3. The certificate(s) of accuracy should be attached.  Ensure that the study number, consent form(s) translated, and the PVD are accurately captured on the certificate(s) of accuracy and are consistent with the consent form(s) being submitted.
4. Attach a copy of the CIRB approval letter for the English version of the translated consent form(s) being submitted.
5. Provide any other information regarding the submission, if applicable.

Document(s) created by the Study Team and/or Outside Source document(s) translated by the Study Team and/or Outside Source Materials Modified and Translated by the Study Team

1. These documents require submission and CIRB approval of the English version before submission of the translated versions.
2. Provide a list of translated documents.  For each document indicate the language, include the name of the document and the version of the document.  If there are multiple documents combined into one document, list the subsections of the combined documents, and indicate which are from an outside source and which are created/translated by the Study Team.
3. The certificate(s) of accuracy should be attached.  Ensure that the study number, documents translated, and the versioning of the documents are accurately captured on the certificate(s) of accuracy and are consistent with the study materials being submitted.
4. Attach a copy of the CIRB approval letter for the English version of the translated participant /recruitment materials being submitted.
5. Provide any other information regarding the submission, if applicable.

Translation by an Outside Source being used as Provided

1. Provide a list of outside source instrument(s)/document(s).  Include for each document, the language,  the name of the document and the version of the document.  If there are multiple documents combined into one document, list the subsections of the combined document(s).  All sections of the combined document must be obtained and translated by an outside source.
2. Attach a copy of the translated documents.
3. Attach a copy of the CIRB approval letter for the English version of the translated outside source instrument(s)/document(s) being submitted. If the English version has not been previously approved, attach a copy of the English instrument(s)/document(s).
4. Provide any other information regarding the submission, if applicable.