Full
Outline
The “subcenter contract” is the basis of multi-center research initiated by investigators. It is a crucial contract document for agreeing on the mutual power and responsibilities of the various institutions participating in the study. This paper analyzed the general characteristics of 158 subcenter contracts for investigator initiated trials (IIT) and assessed the common problems. All the 158 IIT subcenter contracts were in Chinese text, most contracts were signed with university affiliated hospitals and prefecture-level hospitals, most contracts were signed with oncology hospitals and general hospitals, and most of the contracts adopted unified templates of the leading units. Among the 40 template contracts, the common problems were as follows: 45.9% of the contracts did not mention the way of providing research drugs, 51.3% did not specify the adverse drug reaction monitoring and reporting responsibilities during the study, 60% did not mention the subject damage liability, 50% did not state who were responsible for data preservation after the end of the study, misplacement of the regulations that IIT should follow or refer to, missing or unclear key elements of the contract, unclear responsibility for clinical research and supervision, etc. According to the above analysis results, this paper respectively put forward thoughts and suggestions on the legal and regulatory basis to be followed by IIT, the provision of research drugs, adverse reaction monitoring report, the confidentiality and preservation of research data, intellectual property sharing, subject damages, and the key elements of research contract.
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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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