Informational materials such as Investigator's Brochures, updated package inserts and any other materials requiring submission via a Notification (reportable event) in eProst should be submitted to the HSRO in a timely manner. The HSRO shall acknowledge receipt of such materials either by correspondence to the principal investigator or by executing the 'Acknowledged/Noted' activity in eProst. The HSRO shall make these items available to the IRB Chair or designee who shall determine whether further IRB action is required. If no further IRB action is required, the material shall be added to the study file kept by the HSRO. If further action is required, the IRB Chair or designee may request that the HSRO seek information or modifications from the principal investigator or he/she may refer the submission to the convened IRB for its deliberation and resolution. Investigators are reminded that all changes in research, including changes to study personnel, must be submitted as an Amendment and not in a Notification form. Notification forms communicating changes in research shall not be accepted by the HSRO.