Full
Outline
To analyze the requirements of different sponsors for serious adverse event (SAE) reporting in clinical trials and the existing problems of suspected unexpected serious adverse reaction (SUSAR) report submission after the implementation of new edition of GCP thus to give possible suggestions to guide the trial parties in drug trial safety alert work and clinical trial risk control and improve the management of SAE/SUSAR.
SAE reports of 60 applicants and SUSAR reports of 64 applicants from July 1, 2020 to December 31, 2020 were collected. Taking the report submitted by the same sponsor in the same format as one valid study sample, 62 valid original SAE reports and 87 SUSAR reports were included for the analysis.
In the submitted SAE forms, 61.3% used the template designed by the sponsors, 32.3% used the original CFDA SAE report template, 6.4% used SAE reports derived directly from EDC. Differences existed in SAE forms provided by different sponsors. For the design of these SAE forms, there were problems such as field duplicate, unreasonable setting of field options, logistic problems, missing necessary fields, handwritten filling out, unclear fonts, and so on. Among the SUSAR reports received by the institute, 38 applicants reported individual SUSAR cases, 5 out of which (13.116%) used self-made form templates, 10 out of which used the original CFDA form template (26.31%), and 23 sponsors using the CIOMS form template (60.53%), showing that CIOMS template was the most commonly used for case reports. The 49 sponsors who submitted the column matrix used different formats, fields, and varied in time of submission.
There is no unified template for the SAE report form in the industry. Sponsors need to strengthen the normative design and filling guidelines for the SAE report form, so that the researchers can fill out the SAE report more efficiently and ensure the data quality of individual case safety reports. There are significant differences in the SUSAR reports submitted to institutions and ethics committees among different applicants. Some forms are not sufficient to meet the requirements of security information review, and the time limit and frequency of submitting SUSAR reports are different. Under the above-mentioned situation institutions and ethics committees may not be able to accurately determine the risk levels of the clinical trials and subjects. So the SAE/SUSAR report forms need to be further unified and standardized.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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