In order to deeply implement the guidelines of the third session of the leading group of the medical product real-world data application piloting in 2021, and accelerate the real-world studies in Lecheng, on afternoon of April 1,2022, the Hainan Institute of Real World Data held a training session on the operation mechanism and related processes of Lecheng Ethics Committee and Hainan Real-World Data Platform. The conference was chaired by Yao Chen, vice president of Hainan Institute of Real World Data. Wang Chao, secretary of the Ethics Committee of Lecheng Pilot Zone, first introduced the background for the establishment of the committee, its articles of incorporation and relevant requirements in its actual operations, so that the attendees could better understand the working mechanism of the committee and better promote the ethical construction and review of Lecheng Pilot Zone.

Later, Yao Chen introduced the major concerns of real-world study ethical review from aspects such as data security, privacy protection and informed consent, reminding applicants, researchers and other relevant parties to pay more attention to these aspects and carry out research in compliance with relevant laws and regulations.
The Ethics Committee of Lecheng Pilot Zone was established under the guidance of the Health Commission of Hainan Province and initiated by the Lecheng Administration, with an aim to improve the ethical review capacity and multi-center clinical research review efficiency of Lecheng Pilot Zone, and accelerate the application of licensed imported medical products and the progressing of real-world study.
Finally, a training session was held on the use of Hainan Real-World Data Platform, which covered such aspects as account application and approval, project approval, data collection, and statistical analysis.The aim was to further enhance the understanding of the platform’s functions among its users including medical product enterprises, researchers and regulators, so as to promote the wide application of the platform and provide high-quality data support for real-world studies. As the first regional real world data platform established in China in accordance with the NMPA guidelines on real-world study, the platform will provide support for the real-world study for medical product registration and in-process and post-process supervision of regulatory authorities.
The conference was attended online by more than 100 people from various organizations such as medical institutions, medical product enterprises, CRO companies, and regulatory authorities, to further enhance the understanding of concerned parties in such aspects as ethical consideration, data quality control and safety protection in real-world studies.