LINGUISTIC VALIDATION AND EPRO – VALUE OF COLLABORATION
Author(s)
Zarzar KM1, Dawsey R21TransPerfect, Durham, NC, USA, 2TransPerfect, Atlanta, GA, USA
Presentation Documents
OBJECTIVES: As the use of clinical outcomes assessments in global studies continues to rise, and electronic modes of administration proliferate, collaboration between ePRO and linguistic validation providers becomes critical to the success of global initiatives. This cooperation enables the incorporation of the electronic mode of administration into the cognitive interviewing stage of linguistic validation, allowing respondents to view the content in context. Collaboration between ePRO and linguistic validation providers also yields time and cost efficiencies to the sponsor. METHODS: A review of prior collaboration with four ePRO providers was conducted to provide insight into key areas for efficiency prior to initiation of a large-scale linguistic validation project involving ePRO. Prior to project initiation, a detailed workflow was outlined, a review of relevant ePRO file formats was conducted, and processes and milestones were developed with input from the linguistic validation provider, the ePRO provider, and the sponsor to ensure deadlines were met. RESULTS: Reviews of prior projects revealed early collaboration was commonly impeded as the development of the ePRO platform often initiates on different timelines than linguistic validation process. Common reasons include differing contracting timelines from the sponsor for each service, and addition of countries or languages after ePRO contract execution. By building a collaborative project workflow ahead of project initiation, the ePRO and linguistic validation partners can identify cost and timeline efficiencies in 1) the source content, 2) uploading the translated language directly into ePRO platforms, 3) use of ePRO mode in cognitive interviews, 4) post-localization testing of fonts and characters, and 5) proofreading of the final screenshots. CONCLUSIONS: Timeline restrictions resulting from study deadlines and contracting processes can limit the benefit to be achieved by collaboration between ePRO and linguistic validation partners. Early planning, and contracting of each provider with the expectation of collaboration will enable cost and timeline efficiencies, and process improvements.
Conference/Value in Health Info
2011-11, ISPOR Europe 2011, Madrid, Spain
Value in Health, Vol. 14, No. 7 (November 2011)
Code
PRM46
Topic
Methodological & Statistical Research
Topic Subcategory
PRO & Related Methods
Disease
Multiple Diseases