2.11. Plans to promote participant retention and complete follow-up
EVENT
Follow-up will be performed either at homecare or during hospital admission. Notably, patients will be required to attend to the outpatient clinic 5 to 7 days after being discharged from the emergency department (as a safety measure); however, we do not think this will imply a considerable extra-effort that would prevent patients to complete follow-up. In each medical follow-up visit (be it face-to-face or by phone), the clinical investigator in charge will remind the patients of the importance of correctly following the study procedures and encourage them to carry on in the clinical trial.Protocol deviations will be documented and explained in detail by the study team. In the event of a “serious” protocol violation, the monitoring team will record all protocol breaches/deviations. The sponsor will review all protocol deviations and assess whether they represent a “serious” violation according to Good Clinical Practice guidelines. The sponsor will inform the IRB of any protocol breach/deviation that could impact on patient safety and on data integrity.