Patient Reported Outcomes are more accurate and reliable when recorded electronically rather than on paper. Unfortunately, the solutions have historically required a separate mobile application that is costly and time-consuming to administer. With clinCORE, it is now possible for patients to enter their data directly into an EDC, providing immediate data access for sponsor and site personnel.

During study design, the forms used by patients are built alongside the other forms in the trial. Edit checks are programmed to test data validity, and to set the expected time windows for data entry. A patient may then be registered to our EDC by the site coordinator. The details of that user registration are blinded to all sponsor personnel. The patient gets email notifications whenever data is expected, then clicks on a link in that email and enters the required password to log on. The patient is then presented with the forms expected in that time window, enters the data through simple web dialogs, and is logged off automatically when the last form is completed. At this point the data is immediately available in our EDC and appears automatically in the data exports.

clinCORE’s EDC provides the benefits of contemporaneous patient data, without needing a separate ePRO system.