临床试验听听看 ▎ICH GCP 4.11

药物临床试验网 · 公众号 · 药品 · 2017-08-09 17:00

正文

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都应当立即向申办者报告。即时报告应理解为迅速的详细书面报告。即时和随访报告中的受试对象鉴别应当采用采用指定给试验受试对象的独特号码，而不是受试对象姓名、个人身份号码和/或地址。研究者还应当服从关于管理当局和IRB/IEC报告非预期的药物严重不良反应的适用管理要求。
4.11.2 Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol.
在试验方案中被确定为对安全性评价是关键的不良事件和/或实验室异常应当按照报告要求和申办者在方案中说明的时限内向申办者报告。
4.11.3 For reported deaths, the investigator should supply the sponsor and the IRB/IEC with any additional requested information (e.g., autopsy reports and terminal medical reports).
对于所报告的死亡事件，研究者应当向申办者和IRB/IEC提供所需要的全部附加资料(如解剖报告和最终医学报告)。