1. Notifications to be made by the responsible investigator / investigator: 1.1. While conducting clinical trial the responsible investigator/investig
{"Image DocumentName": "Order of MoH Ukraine # 523 from", "Image ImageDescription": "1. Notifications to be made by the responsible investigator / investigator: 1.1. While conducting clinical trial the responsible investigator/investigator shall report all serious adverse events to the sponsor except for those that the protocol or investigator\u2019s brochure identifies as such not requiring immediate reporting. The initial and follow-up reports shall identify subjects by unique code numbers assigned to them for the study The responsible investigator/investigator shall also report the sponsor any adverse events and/or laboratory abnormalities identified in the clinical trial protocol as critical to safety evaluations according to the requirements and within the time periods specified by the sponsor in the protocol.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}