Full
Outline
This expert consensus aims to standardize the review responsibilities and key points for institutional parties, including the Ethics Committees, Institutional Management Departments, and Investigators, in decentralized Clinical Trials (DCTs). As DCT approaches extend trials to participants' daily lives using digital technologies, traditional supervision faces new challenges. Based on the International Council for Harmonisation E6(R3) (ICH E6[R3]) and Chinese Good Clinical Practice (GCP) regulations, the consensus systematically outlines core review elements across the DCT lifecycle. Ethics Committees are required to focus on ethical rationale of the trial design, the substantive equivalence of electronic informed consent (eConsent), data privacy and security, and special protection of vulnerable populations. Institutional Management Departments should strengthen their review of regulatory compliance, third-party vendor management, end-to-end data quality control, and risk management. Investigators must ensure the scientific reliability of remote assessments, timely safety monitoring of trial participants, and their team's competency in implementing new technologies. The consensus emphasizes the need for a close collaboration mechanism among these three parties to promote the healthy and orderly development of DCT approaches in China while safeguarding participant rights and safety, thereby providing actionable guide for the industry.
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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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