The aim of the AMS -ePRO system is to enable patients to enter online (on their own smartphones, tablets or computers) their health related data in response to a questionnaire (e.g. for Quality of Life) or diary, in addition to the study data recorded by the investigational sites in studies.
The AMS -ePRO system shall be used whenever patient diaries or patient questionnaires should be completed directly by the patients. The patients will be trained on the system and their user accounts will be created by the investigational sites. The sites will also deactivate the patient user account as soon as all required diary / questionnaire data are available, or when the patient terminates the study. The patient can enter (and change) diary / questionnaire data during a defined time window. Afterwards the data will be locked to prevent further editing. The site can review the patients' data at any time, and a printout of the patients' diaries and questionnaires can be generated by the site for inclusion in the patient’s health record. Programmed online/interactive checks make sure that the entered diary / questionnaire data are logical and clean.
The diary / questionnaire data held in the AMS -ePRO system can be exported and then analysed together with the other study data from the sites. An audit trail will be maintained to record all user actions. The use of this ePRO system will be included in the informed consent process and described in the patient information sheet of affected projects. The patient personal data will be handled confidential and will saved in a protected area, all according to data protection laws.