Data Collection Procedures

To accomplish the specific aims of the project, data will be stored in a database system after each completed collection step and transferred to central data management for further data processing and merging. Each participant will be assigned a unique identification code consisting of a number identifier that will be used for data merging. After data collection, data validation checks will be performed as agreed in a data validation plan, and data cleaning procedures will be used as applicable to ensure the best achievable quality of data for analysis purposes. Only the study staff working with the fieldwork provider will be able to identify the participants based on the identification codes. Only deidentified data will be transferred from the fieldwork provider to the central data management. All electronic data files will be kept on secure servers with backup processes in place. Personal data of participants must be strictly kept separately from study data and is accessed only by authorized staff for the purposes of the study conduct. Before starting data collection, the involved staff will receive training on the background and objectives of this study, on eligibility criteria, on the participant selection procedure, on ethical obligations, on completion and validation of the procedure, and on the data collection platform. Local fieldwork staff will be trained for each relevant data collection process and logistic-related procedure.

Eligible participants are informed about the study purpose, their requested tasks, time of involvement, data confidentiality, and data protection. Once they stated their willingness to participate, they will proceed with the screening and study enrollment. Enrolled participants have the right to stop their participation at any time without any penalty. Preferably, the reason for the premature end of participation will be recorded. Participants who drop out will not be replaced. Every effort will be made to protect participant confidentiality according to the General Data Protection Regulation.