ABSTRACT
Effective supervision of the clinical research management department can guarantee and improve the quality of the investigator initiated trials(IIT). The authors analyzed relevant clinical research regulations and literature and summarized the current situation of risk-based IIT project process quality management. On such basis, they determined the risk-based IIT project process quality management method in combination with the previous research of the research group.From 2021 to 2022, this method was used to implement process quality management for 353 IIT projects in Shanghai′s tertiary hospitals. More than 3 000 risk points were identified through centralized supervision, and then on-site supervision was carried out to correct the problems found. As proven by the results, the method could find existing problems in time and define the risk level of the project, and also formulate an individualized risk supervision plan accordingly, so as to effectively ensure the data reliability and scientific results. It is suggested that the clinical research management department implement risk based management for the whole process of IIT projects, increase funding and staffing, and implement hierarchical management for the projects by research types, so as to promote the sustainable development of IITs.
ABSTRACT
In the present study,the trachea of 17 new borns and 10 animals, including rabbits, dogs and monkeys were used. The neural elements were visualized by Cajal-Faworsky silver impregnation and osmic acid techniques. Specimens were cut in to sections by freezing microtome and stained by Gros—Bielchowsky method.Branches from the recurrent laryngeal and vagus nerves pass to the trachea,dividing and rejoining to form a mesh-like plexus outer to the cartilage. Fibers of the posterior parts of the plexus appear as a well-defined longitudinal chain of nerves. The branches from this plexus re-form a primary, secondary and tertiary plexuses in the membrane of cartilage plates, in the muscle, the submucous regions and the mucosa.Parasympathetic effector neurons were mostly found in the posterior and lateral wall, on rare occasions the anterior wall.A profuse supply of predominantly unmyelinated fibres innervates the muscle,blood vessels and glands, and the plexuses supplying these structure apparently communicate with each other. They also contain some thinly myelinated fibres.In the layer of smooth muscle the nerve fibres give off fine collaterals and end in knob-like or arrowheaded swellings. The fibres of subepithelial plexuses branch rectangularly and pass between the epithelial cells. All these fibers terminate in knobs which lie among the deep epithelial cells.