In April 1986, our hospital was approved to establish the Clinical Pharmacology Base of the Ministry of Health. In April 1997, it became the first unit in the national traditional Chinese medicine industry to establish the "National Clinical Trial and Research Center for New Drugs (Traditional Chinese Medicine)" (referred to as the GCP Center). In September 1999, it was renamed as the "National Drug Clinical Research Base". On June 16, 2006, it obtained the qualification accreditation of a drug clinical trial institution jointly carried out by the State Food and Drug Administration and the Ministry of Health, and passed the qualification accreditation review in 2009, 2012 and 2016. On October 16, 2019, 12 professional groups were added.Now, we can undertake registered clinical trial projects in most disciplines, including internal medicine (such as cardiovascular disease, digestive disease, respiratory disease, nephrology, endocrinology, rheumatology and autoimmunity disease, hematology, neurology, psychiatry, and surgery (such as general surgery, orthopedics, urology, thoracic surgery, neurosurgery, cardiovascular surgery), gynecology and obstetrics, pediatrics, dermatology and venereology, ophthalmology, otolaryngology, oncology, oral medicine, emergency medicine, intensive care medicine, anesthesiology, acupuncture and moxibustion, rehabilitation medicine, etc. We can also undertake phase I clinical trial projects.
The office is located in Room 1803 of the advanced study and training building, with a quality control room, monitoring room, and archive room equipped with corresponding equipment and facilities. Currently, there are 6 full-time personnel.
The institution shall establish a leading group for archive management work, equipped with full-time and part-time archivists. The existing special archives warehouse is about 70 ㎡, equipped with anti-theft doors, and uniformly equipped with file intensive cabinets, antimagnetic anti-theft safes, central air conditioners, Dehumidifier, Gaseous fire suppression systems, and temperature Hygrometer, meeting the requirements of anti-theft, light, rat, insect, dust, moisture, fire, and high temperature in the archives room. The institutional archives room has a 24 square meter file reading room, equipped with a computer, photocopying and printing integrated machine, file management software, file reading tables and chairs, and other related file supplies. Various systems for file management, utilization, borrowing, and confidentiality have been established and improved.
The institution has established a comprehensive centralized pharmacy operation mechanism for clinical trials, achieving specialized and integrated management of drugs used in clinical trials throughout the hospital. The clinical trial centralized pharmacy covers an area of approximately 150 square meters and is equipped with an office area, reception area, isolation area, cool area, refrigerated area, and recycling area. The functions of different areas are separated and restricted access by unauthorized personnel is ensured. The data is stored in a locked data file cabinet and cannot be accessed by unauthorized personnel. In order to meet the different requirements of temperature and humidity for the storage of investigational drugs, the clinical trial centralized pharmacy is equipped with special drug storage cabinets, shade cabinets and medical refrigerators with locks to ensure that drugs meet the storage conditions through the use of air conditioners and Dehumidifier; Equipped with a temperature and humidity monitoring system, it can continuously monitor the environment and refrigerator for 24 hours, and is equipped with a temperature and humidity abnormal alarm system.
The institution obtained the ISO9001:2015 Quality Management System Certification for the first time in 2017 and obtained it again in 2020. Personnel in various positions of the institution always adhere to the ISO9001:2015 standard, carry out various quality management work, and continuously improve the construction of the quality management system during the work process. Through continuous optimization and upgrading of management procedures, and timely summary of experience, the institution was approved by the Guangdong Provincial Market Supervision Administration as the construction unit of the "Guangdong Province Drug Clinical Trial Institution Management Standardization Pilot" in March 2021. It is the only drug clinical trial institution in our province that has obtained the qualification for pilot construction, marking that our drug clinical trial institution has the basic conditions for implementing standardization demonstration. Through the implementation of standardization pilot work, we will further promote the transformation of our hospital's drug clinical trial institutions from normalization to standardization, gradually realizing the standardization of institutional software and hardware construction, daily business management, etc., and achieving the construction of a standardized system for institutional quality management. This will provide strong support for the data quality of clinical trial projects, while promoting the institution to move towards a virtuous cycle of self adjustment and self-improvement.
The office is located in Room 1803 of the advanced study and training building, with a quality control room, monitoring room, and archive room equipped with corresponding equipment and facilities. Currently, there are 6 full-time personnel.
The institution shall establish a leading group for archive management work, equipped with full-time and part-time archivists. The existing special archives warehouse is about 70 ㎡, equipped with anti-theft doors, and uniformly equipped with file intensive cabinets, antimagnetic anti-theft safes, central air conditioners, Dehumidifier, Gaseous fire suppression systems, and temperature Hygrometer, meeting the requirements of anti-theft, light, rat, insect, dust, moisture, fire, and high temperature in the archives room. The institutional archives room has a 24 square meter file reading room, equipped with a computer, photocopying and printing integrated machine, file management software, file reading tables and chairs, and other related file supplies. Various systems for file management, utilization, borrowing, and confidentiality have been established and improved.
The institution has established a comprehensive centralized pharmacy operation mechanism for clinical trials, achieving specialized and integrated management of drugs used in clinical trials throughout the hospital. The clinical trial centralized pharmacy covers an area of approximately 150 square meters and is equipped with an office area, reception area, isolation area, cool area, refrigerated area, and recycling area. The functions of different areas are separated and restricted access by unauthorized personnel is ensured. The data is stored in a locked data file cabinet and cannot be accessed by unauthorized personnel. In order to meet the different requirements of temperature and humidity for the storage of investigational drugs, the clinical trial centralized pharmacy is equipped with special drug storage cabinets, shade cabinets and medical refrigerators with locks to ensure that drugs meet the storage conditions through the use of air conditioners and Dehumidifier; Equipped with a temperature and humidity monitoring system, it can continuously monitor the environment and refrigerator for 24 hours, and is equipped with a temperature and humidity abnormal alarm system.
The institution obtained the ISO9001:2015 Quality Management System Certification for the first time in 2017 and obtained it again in 2020. Personnel in various positions of the institution always adhere to the ISO9001:2015 standard, carry out various quality management work, and continuously improve the construction of the quality management system during the work process. Through continuous optimization and upgrading of management procedures, and timely summary of experience, the institution was approved by the Guangdong Provincial Market Supervision Administration as the construction unit of the "Guangdong Province Drug Clinical Trial Institution Management Standardization Pilot" in March 2021. It is the only drug clinical trial institution in our province that has obtained the qualification for pilot construction, marking that our drug clinical trial institution has the basic conditions for implementing standardization demonstration. Through the implementation of standardization pilot work, we will further promote the transformation of our hospital's drug clinical trial institutions from normalization to standardization, gradually realizing the standardization of institutional software and hardware construction, daily business management, etc., and achieving the construction of a standardized system for institutional quality management. This will provide strong support for the data quality of clinical trial projects, while promoting the institution to move towards a virtuous cycle of self adjustment and self-improvement.
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