e-FORM

e-FORM includes two main features that directly involve patients in clinical studies:

• e-ICF (electronic informed consent)
• e-PRO (Patient Reported Outcome)

A Patient Reported Outcome (PRO) is an assessment tool used in clinical studies to collect information directly from patients regarding outcomes such as symptoms, health-related quality of life, and treatment satisfaction.
More precisely, a PRO is defined as any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. The outcome can be measured in absolute terms (e.g., severity of a symptom) or as a change from a previous measurement.
e-PRO includes outcomes such as:

• Pain
• Fatigue
• Depression
• Aspects of well-being (functional and psychological)
• Treatment satisfaction
• Quality of life
• Physical symptoms such as nausea and vomiting

e-PRO questionnaires are filled out by patients in a controlled manner, following the methods and timelines established by the study protocol.
The compilation of questionnaires in a planned and controlled manner improves the quality of the collected data.
The individual patient questionnaire is, in effect, an e-CRF form and must be configured and managed accordingly.
To facilitate understanding by patients, PRO forms are fully localized. In some cases, patient evaluations must be provided within precise timeframes.
e-PRO is designed with a user interface that is simple and intuitive, and is optimized for smartphones, and includes email notifications to remind patients to complete the questionnaires

• Allows patients to fill out questionnaires (patient diary) in a controlled manner, following the methods and timings established by the protocol.
• Collects information directly from the patient on outcomes such as symptoms, quality of life, and treatment satisfaction.
• It is defined as any outcome related to the patient's health status reported by the patient without any interpretation by a clinician or other healthcare provider.
• Includes outcomes such as pain, fatigue, depression, aspects of well-being (functional and psychological), treatment satisfaction, quality of life, and physical symptoms such as nausea and headache.
• The compilation of questionnaires in a temporally planned and formally controlled manner results in a higher quality of collected data.
• The individual patient questionnaire is, in effect, an e-CRF form and, as such, must be configured and managed.
• Full localization of the PRO forms is provided so that the patient can better understand the questions asked by the system.
• Some patient evaluations must be given according to a very strict and precise timeline.
• If required, e-PRO questionnaires can be filled by patient only and/or by the investigator whenever the patient is not capable to do on his/her own.

Both features are designed to be accessible through a simple and intuitive user interface, also optimized for smartphones. There are also email notification mechanisms to remind patients to complete questionnaires on time.