Management status of suspected unexpected serious adverse reaction reports in clinical trial sites
10.3760/cma.j.cn114015-20211124-01187
- VernacularTitle:临床试验中心对可疑且非预期严重不良反应报告的管理现状
- Author:
Juan LIAO
1
;
Yuanji MA
1
;
Hong TANG
1
Author Information
1. 四川大学华西医院感染性疾病中心，成都 610041
- Publication Type:Journal Article
- Keywords:
Clinical trial;
Safety management;
Drug monitoring;
Drug-related side effects and adverse reactions;
Adverse drug reaction reporting systems
- From:
Adverse Drug Reactions Journal
2022;24(4):192-196
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To understand the management status of suspected unexpected serious adverse reaction (SUSAR) reports in clinical trial sites in China after the release of the 2020 edition of Good Clinical Practice (new GCP).Methods:The serious adverse event (SAE)/SUSAR reporting requirements files in each site as of June 30, 2021 were downloaded after logging into the "summary of SAE/SUSAR reporting requirements in national sites under the new GCP" platform on an APP named Yaoyanshe (药研社). The requirements on SUSAR reporting management from above files in each site were extracted, including the acceptance process of the SUSAR reports submitted by the clinical trial sponsor and the processing process after receiving the reports (whether the investigator is required to sign for reading and evaluating theSUSAR reports, the time limit and form/format for the investigator to submit the SUSAR reports to the clinical trial institution and the ethics committee, and the processing method in the clinical trial institution and the ethics committee after receiving the SUSAR reports). The collected data were analyzed by descriptive statistics.Results:The SUSAR reporting requirements files in the analysis were collected from 194 sites in 30 provincial administrative regions across the country. In the acceptance process of SUSAR reports submitted by the sponsor, 69.6% (135/194) of the sites required the investigators to sign for reading and evaluating the SUSAR reports, 24.2% (47/194) required the sponsor to submit the SUSAR reports to the clinical trial institution and/or ethics committee, and 6.2% (12/194) had no clear requirements. In the processing process after receiving the reports, 85.1% (165/194) of the sites required the investigators to submit the SUSAR reports to the clinical trial institution and the ethics committee at the same time, 13.4% (26/194) only required the investigators to submit them to the ethics committee, and 1.5% (3/194) had no clear requirements. Except that 1.0% (2/194) sites had no explicit requirements, for lethal/life-threatening SUSAR, 94.3% (183/194), 2.6% (5/194), and 2.1% (4/194) sites required investigators to submit the reports within 7 days, monthly, and quarterly, respectively. Except that 2.6% (5/194) sites had no explicit requirements, for non lethal/life-threatening SUSAR, 54.6% (106/194), 12.9% (25/194), 29.4% (57/194), and 0.5% (1/194) sites required investigators to submit the reports within 15 d, monthly, quarterly, and semiannually, respectively. Requirements on the form/format of SUSAR reports for investigators in submitting were different among sites. Only 12.9% (25/194) of the sites required the ethics committee to filing or meeting in handling of SUSAR reports, and 5.7% (11/194) required feedback on the handling opinions from the ethics committee.Conclusions:Requirements on SUSAR reporting are of great differences among sites. The management of SUSAR reports in some sites does not meet the requirements in the new GCP, which may affect the risk control in clinical trials and need to be further standardized.
