Translation Services: FAQs
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.
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.
Our company has a preferred provider that we use for translations. Can I submit documents translated by them for review?
Yes, a customer may use their own vendor to translate study documents. Quorum generally accepts valid translation certificates, including those from professional translation companies and in-house translation teams employed by a sponsor, CRO, site, or institution. In addition, Quorum generally accept translation certificates from an individual employed by a sponsor, CRO, site, or institution who is fluent in English and the source language, provided that the employee’s primary responsibility involves the translation of study related documents. Quorum reserves the right to require a back translation or a translation comparison of any translated material submitted to verify the accuracy of the translation. Please contact your Study Manager or InitialStudySupport@quorumreview.com for more information.
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.
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.
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.
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.
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.