Data management in the implementation stage

During the implementation stage of the trial, see SOP Data Management section 4.2. A datahåndteringsrapport (data management report) must be written, and the various tasks, such as verification, validation, coding etc., must be performed in accordance with the data management plan. Any changes to the registration forms must be documented (see DEA Change Log). Once all data has been collected, the database is to be closed (see Database Lock Form).