With the development of medical science, clinical trials play an essential role in pharmaceutical research and development as well as treatment optimization. To accelerate the high-quality development of the hospital, Shenzhen Bao'an Women's and Children's Hospital established a GCP base for drug and medical device clinical trials in May 2024. Funded by Bao’an Association for Science and Technology and organized by the GCP Office of Shenzhen Bao'an Women's and Children's Hospital, a series of themed activities entitled “Responsibility in Mind, Standardization in Action — GCP Protects Patient Safety” were carried out from September to October 2024.
Training Course: Interpretation and Practical Exchange of the Latest GCP Regulations
The training course was held on September 5, 2024, aiming to further standardize the conduct of clinical trials and improve the overall quality of trial implementation. A total of 80 relevant personnel, including principal investigators, research physicians and research nurses, attended the event to share experience and exchange professional insights.
Cheng Xiaoli, Director of the Clinical Trial Institution Office, presided over the meeting and delivered an opening speech. She pointed out that clinical research training is instructive to clinical practice. It can not only strengthen researchers’ awareness of Good Clinical Practice (GCP), but also improve the efficiency of clinical research. She encouraged all participants to make full use of this training opportunity to enhance their professional competencies.
Qian Wenjing, Director of the Ethics Office of The Second People’s Hospital of Shenzhen, shared key considerations concerning medical ethics. Zhang Jinhua, Director of the Pharmacy Department of Shenzhen Songgang Hospital, elaborated on investigators’ responsibilities in clinical trials. Zhang Che, Director of the Pharmacy Department of South China Hospital Affiliated to Shenzhen University, discussed common challenges and solutions in GCP practice, focusing on the implementation and precautions of In Vitro Diagnostic (IVD) trials. Finally, Fan Xiaomei, Director of the Pharmacy Department of Shenzhen Bao'an Women's and Children's Hospital, analyzed major issues regarding source data management in clinical trials.
The on-site discussion was active and enthusiastic. Participants commented that the training was informative, practical and highly instructive. The lectures clarified numerous doubts encountered in daily clinical trials and provided solid guidance for future clinical trials and scientific research.
The training effectively strengthened the GCP and ethical awareness of clinical researchers, improved their theoretical proficiency and practical capabilities, and consolidated key inspection points for drug and medical device clinical trials. It further promoted the high-quality development of clinical trials in the hospital.
Salon: Interpretation and Practical Exchange of the Latest GCP Regulations
On October 23, 2024, the GCP salon, funded by Bao’an Association for Science and Technology and hosted by the hospital’s GCP Office, was successfully held. The event gathered institutional directors, GCP office secretaries, drug administrators and medical device administrators from multiple medical institutions across Shenzhen. Participants conducted in-depth discussions on common difficulties and challenges faced by research teams, institutional offices and ethics committees, and explored potential strategies for further in-depth cooperation.
Chaired by Cheng Xiaoli, the salon invited Professor Wu Jianlong, Chief Pharmacist and Director of the Pharmacy Department of The Second People’s Hospital of Shenzhen. Professor Wu delivered a report on promoting clinical research through the development of drug clinical trials, analyzing the current status and future prospects of GCP work.
Professor She Dingping, Chief Pharmacist and Director of the GCP Office of The Second People’s Hospital of Shenzhen, interpreted the 2024 Trial Measures for the Supervision and Inspection of Medical Device Clinical Trial Institutions. He analyzed the quality management of clinical trials and illustrated core management elements from five dimensions: authenticity, ethics, scientificity, standardization and traceability. Additionally, he summarized key points for clinical trial data verification and cited practical cases to address common difficulties in quality management, winning positive feedback from all attendees.
The salon built a high-quality communication platform for the hospital’s clinical researchers to exchange ideas with external GCP experts. Combined with real cases, participants deepened their understanding of clinical research quality management, which is expected to further elevate the overall quality of clinical research.
Although the 2024 GCP Latest Regulation Interpretation and Practical Exchange Event has concluded, the pursuit of rigorous GCP standards is an ongoing journey. The activity theme — “Responsibility in Mind, Standardization in Action — GCP Protects Patient Safety” — serves as the code of conduct for all clinical trial practitioners.
It is firmly believed that continuous learning and practice will help researchers address increasingly complex challenges in clinical research and fully protect the rights and interests of all trial participants.
All staff will strive to improve the quality of clinical research, accelerate medical progress and optimize treatment options for patients. Moving forward with one heart and one mind, the team will keep pursuing excellence and make greater contributions to the cause of human health.