高级检索

T/JPMA 023—2024《疫苗临床试验安全性随访工作规范》解读

Interpretation of the standard Specification for Safety Follow-up of Vaccine Clinical Trials (T/JPMA 023—2024)

  • 摘要: 江苏省预防医学会于2024年9月2日发布T/JPMA 023—2024《疫苗临床试验安全性随访工作规范》并于2024年9月9日正式实施。该标准规定了疫苗临床试验对受试者免疫后开展安全性随访工作的主要内容和工作程序,适用于疫苗临床试验中对受试者免疫后的不良事件随访工作。预防用疫苗的安全性是临床试验重点关注和评价的内容之一,也是疫苗注册审评的重要内容。安全性随访观察工作实施质量直接影响疫苗评价的科学性。本文对标准的要点内容进行解读,为疫苗临床试验机构、试验现场及专业人员深入理解和推广应用提供指导。

     

    Abstract: The standard Specification for Safety Follow-up of Vaccine Clinical Trials (T/JPMA 023—2024) was published by Jiangsu Preventive Medicine Association on September 2, 2024 and officially implemented on September 9, 2024. This standard specifies the main procedures and key contents for safety follow-up after vaccination in vaccine clinical trials, and it is applicable to the follow-up of adverse events after vaccination in such trials. The safety of prophylactic vaccines is a critical focus in clinical trials and an important aspect of the vaccine registration review process. The quality of safety follow-up directly impacts the scientific validity of vaccine evaluations. This article interprets the key points of the standard and provides guidance for vaccine clinical trial institutions, trial sites, and professionals to enhance their understanding and promote the effective application of this standard.

     

/

返回文章
返回