临床试验听听看 ▎ICH GCP 4.11

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4.11 Safety Reporting 安全性报告 4.11.1 All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports should be followed promptly by detailed, written reports. The immediate and follow-up reports should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects' names, personal identification numbers, and/or addresses. The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) and the IRB/IEC. 除了试验方案或其他文件(如研究者手册)认为不必即时报告的那些严重不良事件(SAE)以外，所有SAE都 ………………………………