Informed consent is one of the key operations in a clinical trial, due to its paramount importance in either clinical and ethical aspects.
It is also one of the most time-consuming procedure, as a full and clear informative must be provided to the patient, before the enrollment and the first visit. Furthermore, in multicentric clinical trials it is difficult to provide similar and consistent information for all the patients in the different investigational sites.
Basic trial information describe the type of procedures the patients will be subject to, in which aspects of the trial his/her compliance is foundamental, and the conduct to be maintained during the whole duration of the study. Moreover, risks and benefits of the investigation must be fully elucidated.
The Video-Assisted Informed Consent (VIC) provide the patients with the basic trial information, with the possibility to discuss and clarify any doubt with the investigator, once the video has been watched. The VIC can be delivered directly to the patient on his/her mobile or shared on wider screens within the investigational site.