| Requires English |
Native English speakers |
| Ability to read English |
| Ability to speak English |
| Ability to understand English |
| Legally authorized representative must read, speak, understand English |
| We have no non-English speaking patients in this population |
| Accommodates translation |
Mentions another language by name: Spanish, American Sign Language, Korean, Xhosa, Swahili, Luganda, French, Arabic, Mandarin, Cantonese, etc. |
| Non-English speakers will be accommodated |
| If applicable, [informed consent] will be provided in a certified translation of the local language |
| Non-English language speaking participants for whom an Institutional Review Board (IRB) approved short form is available |
| The informed consent form must be written in a language fully comprehensible to the prospective patient |
| Any oral or written information will be provided to participants in their own language |
| Patients unable to read/write English are eligible to participate in the overall study but will not be required to participate in the Patient-Reported Outcome questionnaires |
| Self-reported questionnaires will be administered in countries where the questionnaires have been translated into the native language of the region and linguistically validated |
| Standard Operating Procedures (SOPs) are in place pertaining to how to approach and consent participants of limited English proficiency |
