Primary Ciliary Dyskinesia (PCD) is a rare genetic disease characterised by bronchiectasis, rhinosinusitis, and ear disease. We developed harmonized (North America, Europe) pediatric health-related quality of life questionnaires for children (6-12 years), adolescents (13-18 years), and parent respondents. Methods: FDA and EMA Guidances were followed. Focus groups and open-ended interviews were conducted to evaluate the impact: n = 12 specialists in North America, n = 40 health care providers in Europe, and 14 children with PCD, plus parents. Open-ended interviews (children with PCD and parents) included: USA/Canada n = 55; UK/Ireland n = 17. Items were also rated for relevance and importance by patients (n = 110). Transcriptions were analyzed using Atlas.ti/Nvivo to generate saturation grids. Qualitative and quantitative data were used to generate items. Cognitive testing (USA/Canada n = 25; UK n = 44) refined the clarity and comprehensiveness of these measures. Results: Cognitive testing indicated the measures were comprehensive and easy to complete. Preliminary instruments consist of: 1) Child (37 items); 2) Adolescent (43 items); and 3) Parent (41 items) versions with 8-10 scales. Conclusions: PCD-QOL have demonstrated face validity and cross-cultural equivalence. Next, psychometric testing will determine their utility as outcome measures for global, multi-center trials.