IDAS ePRO is the mobile application developed by MCR and specifically designed for integrating with IDAS eCRF.
The application allows the collection of data and patient-rated questionnaires and can be customised to fit study-specific needs. The application is available for both Android devices and Apple phones, and is freely available on both official stores. IDAS ePRO requires an active internet connection to work properly.
Accessing to IDAS eCRF, investigators will be able to easily generate a specific authentication code for every enrolled patient who is willing to use the application IDAS ePRO, The authentication code comes in a PDF document that can be printed and given to the patient.
The navigation between pages is carried on just like any other mobile application, with buttons, input fields and notifications. The patient is able to navigate only through specific pages and cannot access any other eCRF data, including other his own data filled in by the investigator. The data previously entered by the patient can be consulted and possibly modified, if necessary and foreseen.
Every data modification is saved in the IDAS eCRF audit trail. Once a data is entered via IDAS ePRO, it is immediately saved on IDAS eCRF, therefore there is no time gap between the patient data entry and the data availability within IDAS eCRF.
The whole communication process between IDAS ePRO and IDAS eCRF is guaranteed by a security connection via SSL protocol just like the standard access to IDAS eCRF via web browser. Once the patient has completed the clinical trial, or has withdrawn from the study, his access code is revoked on the server side and the mobile application will be immediately disconnected.