512-326-3001
Translation Services

Translation Services

IMPORTANT: TO AVOID INTEGREVIEW FROM TRANSLATING FOREIGN LANGUAGE DOCUMENTS THAT ARE NO LONGER BEING UTILIZED BY THE INVESTIGATIVE SITE, PLEASE NOTIFY INTEGREVIEW TO ARCHIVE.

When non-English speaking subjects are to be enrolled in a study, IntegReview will make every effort to ensure that documents provided to study subjects are translated in a language understandable to the subject or authorized representative.

INITIAL TRANSLATION (REQUEST) PROCESS:

You will be asked on IntegReview’s New Study Submission Form or Request for Translation Form to choose one of the following options:

1. IntegReview to translate – If IntegReview is chosen to provide the translation, an outside translation company of our choice will be utilized, and you will be asked to provide the following information:

Translation language(s)
Whether you require a back translation
Whether you require an American Translators Association accredited individual

OR
2. Investigator/CRO/Sponsor to translate – If you choose to provide your own translation, you will be asked to provide an affidavit to IntegReview, including the following information:

A certification of accuracy
A list of all the documents translated
When the translated document is an informed consent, an electronic copy of the translated IRB approved Informed Consent document

**Upon IRB approval of (English) revisions, you will be responsible for ensuring that all current IRB approved documents in a foreign language are translated to incorporate the revisions.

PLEASE NOTE: YOU MAY NOT SUBMIT A DOCUMENT IN A FOREIGN LANGUAGE UNTIL INTEGREVIEW HAS APPROVED THE ENGLISH VERSION.

PROCESS FOLLOWING INTEGREVIEW INITIATED TRANSLATION:

IntegReview will provide a certificate of accuracy, along with a copy of the translated document(s) to the investigator and Project Manager/Sponsor.
Upon IRB approval of (English) revisions to the informed consent or recruiting materials IntegReview will immediately begin processing the translation to the existing IRB approved foreign language versions. This allows IntegReview to ensure that all foreign language IRB approved documents are current.

PROCESS FOLLOWING INVESTIGATOR/CRO/SPONSOR INITIATED TRANSLATION:

You will be asked to provide the following information on the Request for Translation Form:

A list of all revised documents translated
Submission of the clearly indicated revised translated language either by highlights or tracked changes
A copy of the translated document(s)
A certificate of accuracy, including a listing of all documents translated
When the translated document is an informed consent, an electronic copy of the translated IRB approved Informed Consent document

**Upon IRB approval of (English) revisions, you will be responsible for ensuring that all current IRB approved documents in a foreign language are translated to incorporate the revisions.

Should you have other questions or concerns regarding the IntegReview Translation Policy, please call us at 512-326-3001 or send us an email at integreview@integreview.com.