Collection, Management and Reporting Procedures. The period of collection of adverse events starts from the time of signature of the Informed Consent Form (ICF) by the subject (and/or, for subjects who are minor, by the parents/legal representatives) until the end of the subject’s participation in the clinical study. If a Serious Adverse Event (SAE) is on-going at the final clinical trial visit, it should be followed by the Investigator until it has resolved or has reached a stable condition. After the subject completes the clinical study, the Investigator should also inform the Sponsor (see Sponsor’s contact details below) if he/she becomes aware of an SAE involving a subject who has participated in the clinical study. At each post-enrollment visit, the Investigator will question the subject about AEs using an open non-persuasive question to elicit reporting of AEs, for example “Have you noticed any change in your health since the last visit?” Direct questioning and examination will be performed when appropriate. The Investigator will obtain and maintain in the subject’s files all pertinent medical records, and (if applicable) information and medical judgment from colleagues who assisted in the treatment and follow-up of the subject. If necessary, the Investigator will contact the subject’s personal physician or hospital staff to obtain further details. As a minimum, Investigators are requested to report in the Case Report Form (CRF) and in the report all related adverse events (i.e. undesirable effects) and all Serious Adverse Events, whether related or not.
