Documentation
It is the responsibility of the investigator to ensure that the study is conducted in accordance with the professional code for physicians, the Declaration of Helsinki in its current version, and the study protocol and that the data are properly documented. All data collected in this study must be entered into the eCRF by appropriately authorized persons. This also applies to data from persons who have been excluded from the study. The study site records participation on a patient identification list. This list is used for the identification of the participating persons and contains the patient number, full name, date of birth, and date of admission to the RESPECT trial. The patient identification list remains at the trial centre after the study is completed.Using the audit trail in the REDCaP® online database, all data and corrections are automatically logged with the date, time, and the person making the entry so that former entries can be retrieved at any time.Records and documents related to the RESPECT trial (e.g. documentation of informed consent, worksheets, and other relevant documents) must be retained by the investigator for 10 years in accordance with Good Clinical Practice.