Data management {19}
Resident data will be recorded directly into a custom-designed electronic case record file (eCRF). Data from paper records and diaries will be entered into the eCRF. Questionnaires will be considered source data. There will be no data entry into clinical records within the nursing home. Programming quality control processes will include checks for potential issues during import of raw data into the analysis software. A data validation plan (DVP) specifies the check that is to be performed on resident data for the clinical investigation. When all data from all endpoints of all residents have been entered, discrepancies solved and all reconciliation with the safety database is complete, the database will be locked, and the data will be analysed. Imputation methods will not be applied to the study data. No formal testing of outliers will be performed. All residents from all clusters will be pooled for analysis Data management and handling will be conducted according to the investigation-specific Data Management Plan (DMP) in accordance with applicable guidelines and standard operating procedures (SOPs). Any deviations, i.e. discrepancies and additions from the process defined in the DMP, will be described in an investigation-specific data management report (DMR).