On September 14, our drug clinical trial institution successfully passed the on-site inspection by the expert group of the Guangdong Provincial Drug Administration Evaluation and Certification Center, which marks that our hospital has officially passed the qualification certification by the national drug clinical trial institution.
On September 14, our drug clinical trial institution successfully passed the on-site inspection by the expert group of the Guangdong Provincial Drug Administration Evaluation and Certification Center, which marks that our hospital has officially passed the qualification certification by the national drug clinical trial institution.
Elaborate preparations to accelerate the progress of GCP business
Since the establishment of GCP in early 2022, the leaders have attached great importance to improving the organizational structure in strict accordance with the requirements of the "Pharmaceutical Administration Law of the People's Republic of China", "Quality Management Practice for Drug Clinical Trials", "Administrative Regulations for Drug Clinical Trial Institutions" and other regulations and norms. With establishment of drug clinical trial institution and drug clinical trial ethics committee, formulation of GCP management system, standard operating procedures (SOP) and other standardized documents, the staffs of the institution office, ethics office and professional department are actively selected and sent out for training and study, and experts are invited for guidance. To improve the overall quality of the institution, ethics and researchers, in-hospital training and online training are held many times, to ensure the quality of late-stage clinical trials.
Through more than half a year of preparation, under the leadership of the hospital leaders and the joint efforts of all hospital personnel, the drug clinical trial institution of our hospital has recently completed the recordation on the national recordation management information platform, and successfully passed the first inspection by the provincial drug administration after the recordation.
High-speed development has been affirmed, and quality medical care has been further improved
On the morning of September 14, the expert group of the Evaluation and Certification Center of Guangdong Provincial Drug Administration carried out an on-site evaluation of the qualification of our clinical trial institution.Wang Jichen, president of Guangzhou Royallee Cancer Center and director the institution attended the evaluation meeting, with Zhang Haiyuan, deputy director of the institution, Zhang Yunhong, vice president and director of ethics committee, professor Wang Fangjun, deputy director of ethics committee; professor Ma Lanying, member of ethics committee, and Professor Wu Aiguo, director of oncology surgery, etc.
At the meeting, president Wang Jichen delivered a welcome speech to the expert group on behalf of the hospital and reported on the construction of the drug clinical trial institution. Vice president Zhang Yunhong reported to the expert group on the work of our medical ethics committee. Director Ma Lanying made a report on the preparation of the department on behalf of the oncology professional group.
President Wang Jichen, institution director
Zhang Yunhong, director of ethics committee
Ma Lanying, medical oncology professional group
The expert group conducted a strict GCP knowledge assessment on the institution, the ethics committee and the five professional groups, and asked relevant personnel on-site various questions about drug clinical trials.
Subsequently, the expert group conducted on-site inspections of the institutional office, the GCP center pharmacy, the GCP reference room, the ethics committee office, the ethics committee reference room, and five professional groups.
On-site inspection
The heads of each professional group made a detailed report on the room layout, software and hardware facilities, etc. The expert group carefully reviewed the establishment of system documents, personnel files, training records, drug management and storage, and quality control of institution, ethics, and five professional groups, and asked questions on site.
Finally, the expert group gave feedback on the qualification of drug clinical trial institution of Guangzhou Royallee Cancer Center. The experts fully affirmed the construction achievements of the GCP, and pointed out that, as a new GCP institution, it is necessary to strictly follow the new version of GCP and ethics review. To meet the requirements of relevant laws and regulations, strengthen daily supervision and management, and steadily advance the work.
Never forget the original intention, abide by the hospital motto, and seek development
President Wang Jichen thanked the expert group for their recognition, and promised that in the future, our hospital will, as always, abide by the hospital motto of "respect for life", closely focus on the "patient-centered" service concept, firmly grasp the goals of safe medical care and quality medical care, and strictly in accordance with the relevant regulations of the new version of GCP and ethical review, further improve the management and quality assurance system of drug clinical trials, strictly control the quality of clinical research, and ensure the safety and scientificity of drug clinical trials for the benefit of patients.
