The questionnaire design process in the European Human Biomonitoring Initiative (HBM4EU) González Alzaga, Beatriz Hernández Jérez, Antonio Francisco Lacasaña Navarro, Marina HBM4EU Human biomonitoring Environmental exposures Study design Questionnaire development Data collection Exposure characterization Standardised procedures This document was created for the HBM4EU project. HBM4EU has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 733032. The Swiss participation in this European Program is funded by the Swiss State Secretary for Education Research and Innovation (SERI). Background: Designing questionnaires is a key point of epidemiological studies assessing human exposure to chemicals. The lack of validated questionnaires can lead to the use of previously developed and sub-optimally adapted questionnaires, which may result in information biases that affect the study’s validity. On this ground, a multidisciplinary group of researchers developed a series of tools to support data collection within the HBM4EU initiative. The objective of this paper is to share the process of developing HBM4EU questionnaires, as well as to provide researchers with harmonized procedures that could help them to design future questionnaires to assess environmental exposures. Methods: In the frame of the work package on survey design and fieldwork of the HBM4EU, researchers carried out procedures necessary for the development of quality questionnaires and related data collection tools. These procedures consisted of a systematic search to identify questionnaires used in previous human biomonitoring (HBM) studies, as well as the development of a checklist and evaluation sheet to assess the questionnaires identified. The results of these evaluations were taken into consideration for the development of the final questionnaires. Results: The main points covered by each of the sections included in HBM4EU questionnaires are described and discussed in detail. Additional tools developed for data collection in the HBM4EU (e.g. non-responder questionnaire, satisfaction questionnaire, matrix-specific questionnaire) are also addressed. Special attention is paid to the limitations faced and hurdles overcome during the process of questionnaire development. Conclusions: Designing questionnaires for use in HBM studies requires substantial effort by a multidisciplinary team to guarantee that the quality of the information collected meets the study’s objectives. The process of questionnaire development described herein will contribute to improve the harmonization of HBM studies within the social and environmental context of the EU countries. 2022-03-01T07:28:58Z 2022-03-01T07:28:58Z 2021-12-31 info:eu-repo/semantics/article Beatriz González-Alzaga... [et al.]. The questionnaire design process in the European Human Biomonitoring Initiative (HBM4EU), Environment International, Volume 160, 2022, 107071, ISSN 0160-4120, [https://doi.org/10.1016/j.envint.2021.107071] http://hdl.handle.net/10481/73038 10.1016/j.envint.2021.107071 eng info:eu-repo/grantAgreement/EC/H2020/733032 http://creativecommons.org/licenses/by-nc-nd/3.0/es/ info:eu-repo/semantics/openAccess Atribución-NoComercial-SinDerivadas 3.0 España Elsevier