Brief Introduction of the Institution
Beijing Tiantan Hospital, affiliated to Capital Medical University, is a tertiary comprehensive hospital with a focus on neurology. It is the unit of the Institute of Neuroscience of the Chinese Academy of Medical Sciences. The drug clinical trial institution of our hospital was established in 1997. After 2004, it was renamed as the National Drug Clinical Trial Institute (hereinafter referred to as the institution) of Beijing Tiantan Hospital by the State Food and Drug Administration (NMPA). So far, our school has been certified by NMPA for a total of 14 (including neurology, neurosurgery, cardiovascular, endocrine, digestive, anesthesia, medical imaging (diagnosis), maternity, general surgery, orthopedics, respiratory, critical care Emergency medicine (infectious diseases, cardiovascular and cerebrovascular diseases), pediatrics (pediatric neurosurgery), can undertake Phase I-IV drug clinical trials, as well as device-based clinical trials. In addition, our hospital rebuilt the Phase I clinical laboratory in October 2017, with 50 existing beds, which can be used for the design, implementation and reporting of Phase I clinical trials of innovative drugs. In 2018, NMPA reviewed the institution again, and the hospital also completed the filing of the medical device clinical testing organization.
The hospital's medical equipment is advanced, and many patients from Beijing and all over the country are admitted every year, providing sufficient source conditions for drug clinical trials. Our institution has set up a drug clinical trial agency office, established a management system, design specifications and standard operating procedures corresponding to drug clinical trials. The main investigators of our hospitals for testing various drugs, biological products or devices all have subtropical highs. The medical staff with the above titles has rich clinical experience and clinical trial experience. The management personnel and professional technicians have all received the training of drug clinical trial technology and GCP knowledge, and carried out drug clinical trials in accordance with GCP requirements. The hospital has complete clinical and new drug research infrastructure and technical conditions, and has the team and supporting conditions for conducting drug clinical trials to ensure the quality of clinical trials.
The hospital was approved in August 2013 and formally established the “National Center for Clinical Medical Research of Nervous System Diseases”, which is a major measure for the country to deepen the reform of the medical system and implement the “Twelfth Five-Year Plan for Medical Science and Technology Development”. And the National Health and Family Planning Commission to strengthen the medical science innovation system to enhance the clinical research capabilities to create a high-level clinical and translational research of neurological diseases, specifically responsible for promoting the national clinical research of neurological diseases and the transformation of new technologies and methods.
Our Medical Ethics Committee applied for and obtained the SIDCER/FERCAP Ethics Committee certification in 2010. Through the integration with the international, the ethics committee's work flow and procedures were standardized, and the chief audit committee responsibility system was implemented. In 2013, it passed the three-year review and inspection, which guaranteed the level and quality of the drug clinical trial ethical review. For more details, please refer to the Medical Ethics Committee section of the official website of Beijing Tiantan Hospital.