Quorum Review Inc. - Additional Services - translation

By: Quorum Review  09-12-2011
Keywords: translation, clinical research, Consent Form

Quorum's Translation Services

As part of our dedication to enhancing the clinical research process while providing customers with world-class service, we offer a comprehensive range of translation services. These services provide customers with new and competitive options for their translation needs.

As required by applicable federal regulations, informed consent forms must be provided in a language understandable to the research participant (or his/her legally authorized representative). In addition, other materials provided to participants, including diaries, questionnaires, and recruitment materials, must also be provided in a language understandable to them.

Quorum supports the translations of informed consent forms and other study-related documents in over 100 languages and dialects. Our in-house translators also understand the regulatory requirements for participant protection. When you select Quorum to manage your translations in addition to reviewing your study, we can ensure quality standards are met and translations are completed in a timely manner. You will also save valuable time by eliminating the need to coordinate with outside translations vendors.

Quorum offers many options for the translation of study-related documents. Each service is designed to satisfy the needs of your study at different stages.

    Standard Forward-Translation Services
  • Quorum can assist you with the translation process after the finalization and approval of the English consent form and other English study-related documents. The translation process begins once the English version is approved by the customer and Quorum and/or when the customer requests the translation.

    Fast-Track Translations Service for Consent Forms
  • When the fast-track option is requested during the study submission process, Quorum can expedite your consent form translations so they are completed within 72 hours of the Board’s approval of your English language consent forms Fast track translations are fully certified.

    Standard Back-Translation Services
  • Quorum can assist you with the back-translation of a previously translated document to verify the quality of the initial translation.

    Translation Comparison Model
  • Quorum can review the quality of previously translated documents by comparing them to the original, English version. Quorum issues a certification of comparison detailing any significant differences between the original and translated documents. A translation comparison can be completed more quickly than a standard back-translation, reducing turnaround times by almost half.

Q.    When is a translation needed? >>

If a sponsor or site anticipates any non-English speaking individuals will participate in a Quorum Review IRB approved protocol, then translation of the informed consent document and participant recruitment material(s) into a language understandable to the individual is required. This requirement is in compliance with applicable regulations which state that an informed consent document should be in an understandable language to the subject (or authorized representative). Also, before a site requests translation of study documents, the site must confirm the sponsor/protocol allows enrollment of non-English speaking participants.

Q.    How do I request to have Quorum coordinate a translation? >>

When submitting a new study to Quorum, sponsors, CROs and single sites may request our translation services in the Central Study Questionnaire, Single Site Study Questionnaire, or Principal Investigator Generated Study Questionnaire. There are various options for when you prefer the translation process to begin. Please contact Quorum's Initial Study Support team for assistance with completing our submission forms. If you have already submitted to Quorum, you can update your translation preferences by submitting a Change Request Form for Sites.

Central study sites should contact their sponsor and ask them to request Quorum's translation services for the study. Please also indicate on your Site Information Questionnaire that you will be enrolling non-English speaking participants. If you have already submitted to Quorum you may submit a Site Information Change Request Form to request translations.

Q.    Our company has a preferred provider that we use for translations. Can I submit documents translated by them for review? >>

Q.    What is a valid translation certificate?  >>

Quorum generally requires translation certificates from an outside party contain the following elements:

  • Name and contact information of the company employing the translator.
  • The name of the document, including version and/or date if applicable, or other document identifier.
  • Source and target language (for example, English into Portuguese).
  • A statement of attestation that includes the following language (or very similar): "I hereby certify that the identified translated document is, to the best of my knowledge and belief, a true and accurate translation for the original source document."
  • Name, title and signature of the person certifying the translation.
  • Date of the certification.

Please contact your Study Manager if you have questions about your certificate.

Q.    What if I do not have a valid translation certificate? >>

Quorum is dedicated to streamlining the translation of study material while maintaining appropriate safeguards for participants. Please contact your Study Manager if you have questions about your translation certifications, or about our requirements for a valid translation certificate.

Q.    Does Quorum require translation of material for Canadian sites? >>

Submission of Canadian French material for studies conducted at Canadian sites may be accepted with a translation certificate, or with an attestation from the investigator, sponsor, CRO, or site that the Canadian French document is an accurate representation of the English document.

The attestation should state that the material was prepared by a business or employee of the investigator, sponsor, CRO, or site, who normally conducts business in Canadian French and English, and whose primary responsibility involves the creation, editing and/or translation of study-related material.

Q.    I don't have a staff member fluent in a participant's language, but I plan to enroll non-English speaking participants. Can their family interpret for them? >>

In order to enroll non-English speaking participants there must a non-family member, available on site, who is fluent in a language understood by the participant in order to assist in the consenting process.

Q.    How does Quorum bill for translations? >>

Quorum takes into a consideration many factors in the billing process. For translation projects, Quorum will charge per word fees, discounted per word fees for similar segments previously translated, and/or hourly fees in depending on the translation project. Additionally, Quorum has a standard handling fee that applies to all translations. Quorum strives to exceed industry standards while remaining competitive with the pricing of our translation service. Please contact your Study Manager or Quorum’s Initial Study Support team to request a quote, or if you have billing questions.

Keywords: clinical research, Consent Form, Consent Forms, translation

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