The VLIRT® system can be readily adapted to meet your specific project needs for subject unblinding. Modifications to project systems are quickly mountable, with low impact on timelines. Throughout the trial, incidents of unblinding are closely managed by the system, ensuring data integrity and a complete record for biostatisticians and regulatory personnel. A table of User Role permissions prevents all but pre-authorized users from seeing any data that could be potentially unblinding.
In recent years there has been an upsurge in professional vigilance with regard to maintaining the study blind in clinical trials. Concern about incidental unblinding -- i.e., an unblinding or 'partial unblinding' that occurs accidentally in the course of modifying some other aspect of a trial-- has grown in proportion +
Problem: Protocol complexities often call for a customized approach to unblinding subjects in your clinical trial. First, authorized users need to receive an on-screen message with a very specific set of instructions when they begin to unblind a subject. Second, they need to be presented with a Yes/No option to +