Descripción

REVA (Remote Electronic Virtual Assessment) is a digital version of the traditional paper-based clinical workflow for reporting on developing conditions for subjects enrolled in Otsuka Pharmaceutical Development & Commercialization, Inc. sponsored clinical trials. If you have not signed an ICF for an Otsuka sponsored clinical trial please do not download the app. Study participants are permitted to use the REVA app only after they have reviewed, understood, and signed an informed consent form (ICF) to participate in the study. Please refer to your ICF for more information about the REVA app discuss any questions you have with study staff. Only use REVA as directed by study staff. REVA is not intended to be used to diagnose, prevent, or treat disease or other conditions. REVA does not provide medical advice. • NO COMMUNICATION FROM THE APP TO YOU WILL INCLUDE OR CONSTITUTE MEDICAL ADVICE. • DO NOT IGNORE OR DELAY OBTAINING PROFESSIONAL MEDICAL ADVICE BECAUSE OF INFORMATION GATHERED THROUGH USE OF THE APP. • IN CASE OF A HEALTH EMERGENCY, CALL FOR EMERGENCY SERVICES (911) OR GO TO YOUR LOCAL EMERGENCY ROOM. • IF YOU HAVE TECHNICAL ISSUES REGARDING THE APP PLEASE CONTACT THE STUDY DOCTOR IMMEDIATELY. • IN ORDER TO BETTER PROTECT YOUR PRIVACY, AVOID INCLUDING IDENTIFYING IMAGES IN THE BACKGROUND OF YOUR PICTURE (E.G., PHOTOGRAPHS OF YOURSELF OR FAMILY MEMBERS IN THE BACKGROUND, DOCUMENTS WITH IDENTIFYING INFORMATION, TATTOOS, ETC.) Version 1.x.x of the app is for reporting on rash-like symptoms. As a condition changes, a user can log into the app to fill out questionnaires and take pictures to update their study doctor.