Clinical Trial Institution Office Conducts Specialized Training to Empower Professional Secretaries for Efficient Performance

To further standardize the management of professional clinical trial filings at HeYou Hospital and enhance the practical capabilities of secretaries from various professional departments in understanding filing policies, executing procedures, and preparing materials, on December 24, the Clinical Trial Institution Office organized a specialized training session for secretaries of clinical trial filing departments. A total of 12 secretaries from different clinical professional departments participated in this training.

During the training, the secretary of the Institution Office systematically interpreted the core requirements, application conditions, essential materials, site and facility standards for professional filings, based on the latest versions of policy documents such as the "Regulations on the Administration of Drug Clinical Trial Institutions" and the "Measures for the Administration of Filing of Medical Device Clinical Trial Institutions." The training also provided a detailed overview of the overall arrangement and key timelines for the hospital's filing work. In response to common issues encountered in previous filings, such as non-standard materials, poor process衔接, and inaccurate grasp of deadlines, the training conducted an in-depth analysis, clarified material review standards and precautions, and assisted participants in accurately understanding the key points and difficulties of the filing work.

In the next step, the Clinical Trial Institution Office will continue to follow up on the filing progress of each department, promote the development of internal department SOP training for filing professional departments, and provide one-on-one guidance and support to ensure the standardized and efficient advancement of the filing work, laying a solid foundation for the clinical trial filing work of HeYou Hospital.

(Contributed by Quan Dongling, Clinical Medical Research Center Reviewed by Jian Gang)