Common use of Study Material Translation Clause in Contracts

Study Material Translation. Certain study-related materials may be translated into local languages for HPTN studies involving non-English speaking participants. As a general rule, informed consent forms, community education materials, advertisements, questionnaires, interview forms, and other materials administered or distributed directly to study participants must be translated. The IoRs are responsible for ensuring that study site staff and participants are provided with all required study- related information in a language that is understandable to them. SSP manuals, in whole or in part, also may need to be translated for some sites in some studies. Study sites are responsible for completing all translation tasks unless otherwise arranged with the HPTN LOC, LC and/or SDMC. Translations are completed after the English versions are finalized. Translated informed consent forms must be submitted for protocol registration as described in the DAIDS Protocol Registration Manual.

Study Material Translation. Certain study-related materials may be translated into local languages for HPTN studies involving non-English speaking participants. As a general rule, informed consent forms, community education materials, advertisements, questionnaires, interview forms, and other materials administered or distributed directly to study participants must be translated. The IoRs are responsible for ensuring that study site staff and participants are provided with all required study- related information in a language that is understandable to them. SSP manuals, in whole or in part, also may need to be translated for some sites in some studies. Study sites are responsible for completing all translation tasks unless otherwise arranged with the HPTN LOC, LC and/or SDMC. Translations are completed after the English versions are finalized. Translated informed consent forms must be submitted for protocol registration as described in the DAIDS Protocol Registration Manual.